Case 2:15-cv-01740-JRG-RSP Document 1 Filed 11/09/15 Page 1 of 13 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF TEXAS
`MARSHALL DIVISION
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`
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`WARNER CHILCOTT (US), LLC,
`WARNER CHILCOTT COMPANY, LLC,
`AND QUALICAPS CO., LTD.,
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`
`
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`COMPLAINT FOR PATENT INFRINGEMENT
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`Plaintiffs Warner Chilcott (US), LLC, Warner Chilcott Company, LLC (collectively,
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`“Warner Chilcott”), and Qualicaps Co., Ltd. (“Qualicaps”), (collectively, “Plaintiffs”), by their
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`attorneys, for their complaint against Mylan Pharmaceuticals, Inc. (“Mylan Pharmaceuticals”),
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`Mylan Laboratories Limited (“Mylan Limited”), and Mylan, Inc. (“Mylan, Inc.”), (collectively,
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`“Defendants” or “Mylan”) allege as follows:
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`Nature of the Action
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`1.
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`This is a civil action for patent infringement arising under the patent laws
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`of the United States, 35 U.S.C. § 100 et seq., and in particular under 35 U.S.C. § 271(a-c, e).
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`This action relates to Abbreviated New Drug Application (“ANDA”) No. 207826 filed by or for
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`the benefit of Mylan with the U.S. Food and Drug Administration (“FDA”) for approval to
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`market a generic version of Warner Chilcott’s DELZICOL® pharmaceutical product,
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`
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`Civil Action No. 2:15-cv-1740
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`Plaintiffs,
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`v.
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`MYLAN PHARMACEUTICALS, INC.,
`MYLAN LABORATORIES LIMITED,
`AND MYLAN, INC.,
`
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`Defendants.
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`
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 1
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`Case 2:15-cv-01740-JRG-RSP Document 1 Filed 11/09/15 Page 2 of 13 PageID #: 2
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`mesalamine delayed release capsules, 400 mg, that is sold in the United States (the “Generic
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`Product”).
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`2.
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`This is also an action under 28 U.S.C. §§ 2201-02 for a declaratory
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`judgment of patent infringement arising under the patent laws of the United States, 35 U.S.C. §
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`100 et seq., and in particular under 35 U.S.C. § 271(a-c, e).
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`The Parties
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`3.
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`Plaintiff Warner Chilcott (US), LLC is a limited liability company
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`organized and existing under the laws of the state of Delaware with offices at 100 Enterprise
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`Drive, Rockaway, NJ 07866.
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`4.
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`Plaintiff Warner Chilcott Company, LLC is a limited liability company
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`organized and existing under the laws of Puerto Rico with offices at Union St., Road 195, Km
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`1.1, Fajardo, Puerto Rico.
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`5.
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`Plaintiff Qualicaps Co., Ltd. is a corporation organized and existing under
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`the laws of Japan with offices at 321-5, Ikezawacho, Yamatokoriyama, Nara, Japan.
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`6.
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`On information and belief, Defendant Mylan Pharmaceuticals, Inc. is a
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`corporation organized and existing under the laws of West Virginia with its principal place of
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`business at 781 Chestnut Ridge Road, Morgantown, West Virginia 26505.
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`7.
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`On information and belief, Defendant Mylan Laboratories Limited is a
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`corporation organized and existing under the laws of India with its principal place of business at
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`Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad 500034, India.
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`8.
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`On information and belief, Defendant Mylan, Inc. is a corporation
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`organized and existing under the laws of Pennsylvania with its principal place of business at
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`1000 Mylan Boulevard, Canonsburg, Pennsylvania 15317.
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`
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`–2–
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 2
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`9.
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`On information and belief, Mylan Pharmaceuticals is a wholly owned
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`subsidiary of Mylan, Inc.
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`10.
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`On information and belief, Mylan Limited is a wholly owned subsidiary of
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`Mylan, Inc.
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`11.
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`On information and belief, Mylan, Inc., Mylan Pharmaceuticals, and
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`Mylan Limited are agents of each other and/or work in active concert either directly or through
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`one or more of their wholly owned subsidiaries and/or agents to develop, manufacture, distribute,
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`market, offer to sell, and sell generic drug products for sale and use throughout the United States,
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`including within Texas and this judicial district.
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`12.
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`On information and belief, Mylan Limited manufactured the Generic
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`Product relied upon in ANDA No. 207826 to purportedly demonstrate bioequivalence to Warner
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`Chilcott’s DELZICOL® product.
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`13.
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`On information and belief, Mylan Limited and Mylan, Inc., participated in
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`operations related to preparing ANDA No. 207826 and/or contributed employees to the
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`preparation of ANDA No. 207826.
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`14.
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`On information and belief, if ANDA No. 207826 is approved by FDA the
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`Generic Product will be manufactured by Mylan Limited for sale by Mylan within the United
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`States, including within this judicial district.
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`15.
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`On information and belief, Mylan Pharmaceuticals Inc. and Mylan
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`Limited are within the control of Defendant Mylan, Inc. for purposes of responding to discovery
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`in this action.
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`–3–
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 3
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`Jurisdiction and Venue
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`16.
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`This is a civil action for patent infringement arising under the patent laws
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`of the United States, Title 35 of the U.S. Code, for infringement of U.S. Patent No. 6,649,180
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`(“the ’180 patent”).
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`17.
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`This Court has jurisdiction over the subject matter of this action pursuant
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`to 28 U.S.C. §§ 1331, 1338(a), 2201 and 2202.
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`18.
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`On information and belief, Mylan prepared ANDA No. 207826 with the
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`intention of seeking to market the Generic Product throughout the United States, including
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`within this judicial district.
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`19.
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`On information and belief, Mylan, either directly or through an agent,
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`regularly does or solicits business in this jurisdiction, engages in other persistent courses of
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`conduct in this jurisdiction, and/or derives substantial revenue from services or things used or
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`consumed in this jurisdiction.
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`20.
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`On information and belief, Mylan plans to sell the Generic Product in
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`Texas and seek Medicaid reimbursements for sales of the Generic Product in Texas.
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`21.
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`On information and belief, Mylan Pharmaceuticals is a licensed drug
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`distributor in Texas, license numbers 0039237 and 0038090, and has established contacts with
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`Texas wholesalers, retailers, and state agencies to further the sales of its products.
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`22.
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`On information and belief, Mylan’s drug products are listed on the Texas
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`Department of State Health Services’ Drug Formulary.
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`23.
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`On information and belief, Mylan Pharmaceuticals is actively registered
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`with the Texas Secretary of State to conduct business in Texas.
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`24.
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`On information and belief, Mylan Pharmaceuticals has a registered agent
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`in Texas located at 211 East 7th Street, Suite 620, Austin, Texas 78701-3218.
`–4–
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 4
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`25.
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`On information and belief, Mylan markets and sells generic drugs
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`throughout Texas, including in this judicial district. On information and belief, since 2014
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`Mylan and/or its affiliates have sold over $1.3 billion worth of Mylan’s products in Texas, well
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`over $100 million of which were sold in this judicial district. On information and belief, Mylan
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`has and continues to achieve substantial sales of generic drugs in both Texas and this judicial
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`district.
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`26.
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`On information and belief, Mylan, Inc. has further availed itself to the
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`laws of Texas through its subsidiary, Mylan Institutional, Inc., which is located at 12720 Dairy
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`Ashford Road, Sugar Land, Texas 77478.
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`27.
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`On information and belief, the acts of Mylan Pharmaceuticals and Mylan
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`Limited complained of herein were done at the direction of, with the authorization of, and/or
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`with the cooperation, participation, and assistance of Mylan, Inc.
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`28.
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`On information and belief, Mylan has customers who are residents of the
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`State of Texas and of this judicial district, who use and have used Mylan products in the State of
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`Texas and in this judicial district, and from whom Mylan has derived substantial revenue.
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`29.
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`On information and belief, Mylan knows and intends that its proposed
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`Generic Product, once approved by FDA, will be distributed and sold in Texas and will displace
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`sales of Warner Chilcott’s DELZICOL® product causing injury to Warner Chilcott. Mylan also
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`intends to take advantage of its established channels of distribution in Texas for the sale of its
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`proposed Generic Product. On information and belief, these channels of distribution were
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`arranged by Mylan to take advantage of the Texas market, the third-largest market for
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`prescription drugs in the United States.
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`
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`–5–
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 5
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`30.
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`On information and belief, by virtue of at least, inter alia, Mylan’s
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`continuous and systematic contacts with Texas, including but not limited to the above-described
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`contacts, this Court has general and specific personal jurisdiction over Mylan. These activities
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`satisfy due process and confer personal jurisdiction over Mylan consistent with Texas law.
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`31.
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`Venue is proper in this judicial district pursuant to 28 U.S.C. §§ 1391 and
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`1400(b).
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`Regulatory Requirements for New and Generic Drugs
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`32.
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`A person seeking to market a new drug that has not previously been
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`approved by FDA (a “pioneering” drug) must file a New Drug Application (“NDA”) with FDA
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`demonstrating that the drug is safe and effective for its intended use. 21 U.S.C. § 355(b).
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`33.
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`A person seeking to market a generic copy of a drug that previously has
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`been approved by FDA may follow a truncated approval process by filing an ANDA for a
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`generic version of that drug. In the ANDA, the applicant must demonstrate, among other things,
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`bioequivalence of the generic copy with the pioneering drug. 21 U.S.C. § 355(j)(2)(A)(iv).
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`34.
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`Unlike an NDA applicant, an ANDA applicant is not required to include
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`safety and effectiveness data. Instead, the ANDA applicant is permitted to rely on the approval
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`of the NDA applicant’s drug—in essence, piggybacking on the NDA application for purposes of
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`safety and effectiveness conclusions. 21 U.S.C. § 355(j).
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`35.
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`Nor does an ANDA applicant establish any new conditions of use for the
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`proposed drug product. Instead, an ANDA applicant may seek approval only for conditions of
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`use that previously have been approved in connection with an approved NDA. 21 U.S.C.
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`§ 355(j)(2)(A)(i).
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`
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`–6–
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 6
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`The Approved Drug Product
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`36. Warner Chilcott is the current holder of NDA No. 204412 for mesalamine
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`delayed release capsules, 400 mg, which was approved by FDA on February 1, 2013. Warner
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`Chilcott markets the approved drug product under the trade name DELZICOL®.
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`37. Warner Chilcott’s DELZICOL® product is approved for the treatment of
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`mildly to moderately active ulcerative colitis in patients 12 years of age older and for the
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`maintenance of remission of ulcerative colitis in adults.
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`38.
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`A true, correct, and complete copy of the prescribing information for
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`Warner Chilcott’s DELZICOL® product approved in NDA No. 204412 is attached as Exhibit A.
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`39.
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`The ’180 patent is listed in FDA’s Orange Book—formally known as
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`Approved Drug Products With Therapeutic Equivalence Evaluations—in connection with NDA
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`No. 204412.
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`40.
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`Qualicaps is the owner of the ’180 patent. Warner Chilcott Company,
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`LLC has an exclusive license to manufacture DELZICOL® under the ’180 patent.
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`41. Warner Chilcott currently markets mesalamine delayed release capsules,
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`400 mg, in the United States under the trademark DELZICOL®. The DELZICOL® product
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`falls within the claims of the ’180 patent.
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`ANDA No. 207826
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`42.
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`On information and belief, on or before September 28, 2015, Mylan
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`Pharmaceuticals submitted to FDA an ANDA (ANDA No. 207826) with a paragraph IV
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`certification under section 505(j)(2)(A)(vii)(IV) of the Federal Food, Drug, and Cosmetic Act
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`(“FDCA”), 21 U.S.C. § 355(j)(2)(A)(vii)(IV), for mesalamine delayed release capsules, 400 mg,
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`purportedly bioequivalent to Warner Chilcott’s DELZICOL® product. The purpose of the
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`–7–
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 7
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`ANDA is to obtain approval under section 505(j) of the FDCA to engage in the commercial
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`manufacture and sale of the Generic Product.
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`43.
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`On information and belief, Mylan Pharmaceuticals sent Warner Chilcott
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`(US), LLC and Qualicaps a letter dated September 28, 2015 (the “Notice Letter”). The Notice
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`Letter represented that Mylan Pharmaceuticals had submitted to FDA ANDA No. 207826 with a
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`paragraph IV certification for the ’180 patent.
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`44.
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`On information and belief, the purpose of the ANDA and paragraph IV
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`certification is to obtain approval under section 505(j) of the FDCA to engage in the commercial
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`manufacture and sale of the Generic Product before the expiration of the ’180 patent, listed in the
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`Orange Book for NDA No. 204412. Hence, Mylan Pharmaceuticals’ purpose in submitting
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`ANDA No. 207826 is to market the product described therein before the expiration of the ’180
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`patent.
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`Count 1: Infringement of the ’180 Patent
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`45.
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`Plaintiffs incorporate by reference each of the preceding paragraphs as if
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`fully set forth herein.
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`46.
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`The ’180 patent, entitled “Hard capsule formed of cellulose ether film with
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`a specific content of methoxyl and hydroxypropoxyl groups,” was duly and legally issued by the
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`United States Patent and Trademark Office on November 18, 2003. The Orange Book presently
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`shows that the ’180 patent’s term ends on April 13, 2020. Qualicaps is the owner of the ’180
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`patent. Warner Chilcott Company, LLC has an exclusive license to manufacture DELZICOL®
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`under the ’180 patent. A true, correct, and complete copy of the ’180 patent is attached hereto as
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`Exhibit B.
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`–8–
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 8
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`47.
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`On information and belief, Mylan Pharmaceuticals submitted ANDA No.
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`207826 to FDA seeking approval to engage in the commercial manufacture, use, offer for sale,
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`and sale of the Generic Product before the expiration of the ’180 patent.
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`48. Mylan’s manufacture, use, offer for sale, or sale of such a product would
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`infringe the claims of the ’180 patent under 35 U.S.C. § 271(a), (b), and/or (c).
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`49.
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`On information and belief, as part of the ANDA filing, Mylan
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`Pharmaceuticals purportedly provided a written certification to FDA that the claims of the ’180
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`patent are invalid, unenforceable, and/or will not be infringed by the manufacture, use, or sale of
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`Mylan’s generic version of Warner Chilcott’s DELZICOL® product.
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`50. Mylan Pharmaceuticals gave written notice of its certification of
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`invalidity, unenforceability, and/or non-infringement of the ’180 patent, alleging that the claims
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`of the ’180 patent are invalid, unenforceable, and/or would not be infringed by the Generic
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`Product, and informing Warner Chilcott (US), LLC and Qualicaps that Mylan seeks approval to
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`engage in the commercial manufacture, use, and sale of a product bioequivalent to Warner
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`Chilcott’s DELZICOL® product prior to the expiration of the ’180 patent.
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`51. Mylan has infringed the ’180 patent under 35 U.S.C. § 271(e)(2)(A) by
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`virtue of submitting ANDA No. 207826 with a paragraph IV certification and seeking FDA
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`approval of ANDA No. 207826 to market the Generic Product prior to the expiration of the ’180
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`patent.
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`52.
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`On information and belief, if Mylan commercially uses, offers for sale, or
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`sells the Generic Product, or induces or contributes to such conduct, it would further infringe the
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`’180 patent under 35 U.S.C. § 271(a), (b), and/or (c) unless enjoined by the Court.
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`–9–
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 9
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`53.
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`Unless Mylan is enjoined from directly and indirectly infringing the ’180
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`patent, Plaintiffs will suffer substantial and irreparable harm for which there is no adequate
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`remedy at law.
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`54.
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`This case is exceptional, and Plaintiffs are entitled to an award of
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`attorneys’ fees under 35 U.S.C. § 285.
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`Count 2: Declaratory Judgment of Infringement of the ’180 Patent
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`55.
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`Plaintiffs incorporate by reference each of the preceding paragraphs as if
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`fully set forth herein.
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`56.
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`Plaintiffs’ claims also arise under the Declaratory Judgment Act, 28
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`U.S.C. §§ 2201 and 2202.
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`57.
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`There is an actual case and controversy between Plaintiffs on the one side,
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`and the Mylan on the other, creating a justiciable case and controversy for which this Court may
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`grant declaratory relief consistent with Article III of the United States Constitution.
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`58.
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`On information and belief, Mylan has made, and will continue to make,
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`substantial preparations in the United States, including Texas, to manufacture, sell, offer to sell,
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`and/or import the Generic Product.
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`59. Mylan’s actions indicate a refusal to change the course of their actions in
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`the face of acts by Plaintiffs.
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`60.
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`Any commercial manufacture, use, offer for sale, sale, and/or importation
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`of the Generic Product before the ’180 patent expires will constitute direct infringement and/or
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`contribute to and/or actively induce the infringement by others of the ’180 patent.
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`61.
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`On information and belief, Mylan will engage in the commercial
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`manufacture, use, offer for sale, sale, and/or importation of the Generic Product immediately and
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`imminently upon approval of ANDA No. 207826.
`–10–
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 10
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`62.
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`On information and belief, Mylan actively and knowingly caused to be
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`submitted and/or assisted with, participated in, contributed to, and/or directed the submission of
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`ANDA No. 207826 to FDA, while knowing of the ’180 patent.
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`63.
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`The submission of ANDA No. 207826 by Mylan constituted direct
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`infringement of the ’180 patent under 35 U.S.C. § 271(e). Under 35 U.S.C. §§ 27l(b) and
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`271(e)(2)(A), Mylan induced the infringement of the ’180 patent by actively and knowingly
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`causing to be submitted and/or assisting with, participating in, contributing to, and/or directing
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`the submission of ANDA No. 207826 to FDA and knowing that the submission of ANDA No.
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`207826 would constitute direct infringement of the ’180 patent. Mylan’s knowing and purposeful
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`activities of causing to be submitted and/or assisting with, participating in, contributing to, and/or
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`directing the filing of ANDA No. 207826, while knowing that its submission would constitute
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`direct infringement, constitute induced infringement of the ’180 patent.
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`64.
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`Plaintiffs are entitled to a declaratory judgment that future commercial
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`manufacture, use, offer for sale, sale, and/or importation of the Generic Product will infringe the
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`’180 patent.
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`65.
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`Unless Mylan is enjoined from directly and indirectly infringing the ’180
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`patent, Plaintiffs will suffer substantial and irreparable harm for which there is no adequate
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`remedy at law.
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`66.
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`This case is exceptional, and Plaintiffs are entitled to an award of
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`attorneys’ fees under 35 U.S.C. § 285.
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`WHEREFORE, Plaintiffs seek the following relief:
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`Prayer for Relief
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`A.
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`A judgment that Mylan has infringed the ’180 patent under 35 U.S.C.
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`§ 271(e)(2)(A);
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`–11–
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 11
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`Case 2:15-cv-01740-JRG-RSP Document 1 Filed 11/09/15 Page 12 of 13 PageID #: 12
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`B.
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`An order pursuant to 35 U.S.C. § 271(e)(4)(A) providing that the effective date of
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`any FDA approval of ANDA No. 207826 is not earlier than the expiration date of the ’180
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`patent, or any later expiration of exclusivity for the ’180 patent to which Plaintiffs are or become
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`entitled;
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`C.
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`A permanent injunction restraining and enjoining Mylan and its officers, agents,
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`servants, employees, parents, subsidiaries, divisions, affiliates, and those persons in active
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`concert or participation with any of them, from making, using, selling, offering to sell, or
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`importing any product that infringes the ’180 patent, including the product described in ANDA
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`No. 207826;
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`D.
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`A judgment declaring that making, using, selling, offering to sell, or importing the
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`product described in ANDA No. 207826, or inducing or contributing to such conduct, would
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`constitute infringement of the ’180 patent by Mylan pursuant to 35 U.S.C. § 271(a), (b), and/or
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`(c);
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`E.
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`A declaration under 28 U.S.C. § 2201 that if Mylan, its officers, agents, servants,
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`employees, licensees, representatives, and attorneys, and any other persons acting or attempting
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`to act in active concert or participation with them or acting on their behalf, engages in the
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`commercial manufacture, use, offer for sale, sale and/or importation of the product described in
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`ANDA No. 207826, it will constitute an act of direct and/or indirect infringement of the ’180
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`patent;
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`F.
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`A finding that this is an exceptional case, and an award of attorneys’ fees in this
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`action pursuant to 35 U.S.C. § 285;
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`G.
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`H.
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`Costs and expenses in this action; and
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`Such further and other relief as this Court determines to be just and proper.
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`–12–
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 12
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`Case 2:15-cv-01740-JRG-RSP Document 1 Filed 11/09/15 Page 13 of 13 PageID #: 13
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`Respectfully submitted,
`
`/s/ Michael E. Jones
`_______________________
`Michael E. Jones
`mikejones@potterminton.com
`Texas Bar No. 10929400
`POTTER MINTON, PC
`110 North College, Suite 500
`Tyler, TX 75702
`
`Of Counsel:
`George F. Pappas
`Jeffrey B. Elikan
`Michael N. Kennedy
`COVINGTON & BURLING LLP
`One CityCenter
`850 Tenth Street, NW
`Washington, DC 20001
`(202) 662-6000
`
`Attorneys for Plaintiffs
`Warner Chilcott (US), LLC,
`Warner Chilcott Company, LLC,
`and Qualicaps, Co., Ltd.
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`
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`
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`Dated: November 9, 2015
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`–13–
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 13
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`Case 2:15-cv-01740-JRG-RSP Document 1-1 Filed 11/09/15 Page 1 of 17 PageID #: 14
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`EXHIBIT A
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 14
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`Case 2:15-cv-01740-JRG-RSP Document 1-1 Filed 11/09/15 Page 2 of 17 PageID #: 15
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`-------------------------DOSAGE FORMS AND STRENGTHS-----------------­
`Delayed-release capsules: 400 mg (3)
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`
`
`---------------------------CONTRAINDICATIONS---------------------------------­
`Patients with known hypersensitivity to salicylates or aminosalicylates or to
`
`
`
`any of the ingredients of DELZICOL capsules (4, 5.3)
`
`
`
`
`
`------------------------WARNINGS AND PRECAUTIONS----------------------­
`
`• Renal Impairment (for example, minimal change nephropathy, acute and
`
`
`
`
`
`chronic interstitial nephritis, renal failure): Assess renal function at
`
`
`
`beginning of treatment and periodically during treatment (5.1)
`
`
`
`• Mesalamine-induced Acute Intolerance Syndrome: Has been reported.
`
`
`
`
`
`Observe patients closely for worsening of these symptoms while on
`
`
`
`
`treatment (5.2)
`
`• Hypersensitivity Reactions: Use caution when treating patients who are
`
`
`hypersensitive to sulfasalazine. Mesalamine-induced cardiac
`
`
`hypersensitivity reactions (myocarditis and pericarditis) have been
`
`
`
`
`reported (5.3)
`
`• Hepatic Failure: Has been reported in patients with pre-existing liver
`
`
`
`
`
`disease. Use caution when treating patients with liver disease (5.4)
`
`• Prolonged Gastric Retention in Patients with Upper Gastrointestinal
`
`
`
`Obstruction: May lead to a delay in onset of action (5.5)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`04/2014
`
`
`
`
`
` HIGHLIGHTS OF PRESCRIBING INFORMATION
` These highlights do not include all the information needed to use
`
`
`
`
`
`
` DELZICOL safely and effectively. See full prescribing information for
` DELZICOL.
`
`
` DELZICOL (mesalamine) delayed-release capsules, for oral use
` Initial U.S. Approval: 1987
`
`
`
`----------------------------RECENT MAJOR CHANGE-----------------------­
`
`Indications and Usage, Treatment of Mildly to Moderately Active
`
`
`
`Ulcerative Colitis (1.1)
`
`04/2014
`
`
`Dosage and Administration, Dosage for Treatment of Mildly
`
`
`to Moderately Active Ulcerative Colitis (2.1)
`04/2014
`
`
`
`
`Dosage and Administration, Dosage for Treatment of Mildly
`
`
`
`to Moderately Active Ulcerative Colitis (2.1)
`10/2014
`
`
`
`Dosage and Administration, Dosage for Maintenance of Remission
`
`10/2014
`of Ulcerative Colitis (2.2)
`
`
`Dosage and Administration, Important Administration
`
`Instructions (2.3)
`
`Dosage and Administration, Testing Prior to DELZICOL
`
`Administration (2.4)
`04/2014
`
`
`
`---------------------------INDICATIONS AND USAGE------------------------­
`
`
`
`DELZICOL is an aminosalicylate indicated for:
`
`
`
`
`• Treatment of mildly to moderately active ulcerative colitis in patients 12
`
`years of age older (1.1)
`
`• Maintenance of remission of ulcerative colitis in adults (1.2)
`
`
`
`
`----------------------DOSAGE AND ADMINISTRATION-------------------­
`
`• For the treatment of mildly to moderately active ulcerative colitis (2.1)
`
`
`o Adults: 800 mg three times daily with or without
`
`
`
`
`
` food (2.4 grams/day) for 6 weeks
`
`
`o Pediatric Patients 12 years or older: Total daily dose
`
`
`
`
`
` is weight-based up to a maximum of 2.4 grams/day
`
`
` with or without food (see table below); twice daily
`
`
`
` dosing for 6 weeks
`
`
`
` Maximum Daily Dose
`
` Weight Group
` Daily Dose
`
`
` (grams/day)
`
` (mg/kg/day)
`
` (kg)
`
` 1.2
`
`
` 36 to 71
`
` 17 to <33
`
`
` 2.0
`
` 37 to 61
`
`
`
` 33 to <54
`
` 2.4
` 27 to 44
`
`
`
` 54 to 90
`
` • For the maintenance of remission of ulcerative colitis in adults, 1.6 g
`
`
`
`
`
` daily, in divided doses ( 2.2)
`• Do not open, crush, break, or chew the capsules. Swallow whole with
`
`
`
`
`
`water (2.3)
`
`
`• Two DELZICOL 400 mg capsules should not be substituted with one
`
`
`
`
`
`
`mesalamine delayed-release 800 mg tablet (2.3)
`
`
`• Assess children for the ability to swallow capsules (2.3)
`
`
`
`
`• Recommend that renal function be evaluated prior to initiation of
`
`
`
`
`
`
`DELZICOL (2.4, 5.1)
`
`
`
`
`--------------------------------ADVERSE REACTIONS----------------------------­
`
`
`
` The most common adverse reactions (observed in greater than
` or equal to 5% of adults in clinical trials) were abdominal
`
`
`
`
`
` pain, eructation, pain, back pain, rash, dyspepsia, rhinitis, flu
` syndrome, asthenia, flatulence, vomiting, fever, arthralgia,
`
`
` constipation, and gastrointestinal bleeding (6.1)
`
`
`Adverse reactions in children were similar (6.1)
`
`
`
`To report SUSPECTED ADVERSE REACTIONS, contact
`
`Warner Chilcott at 1-800-521-8813 or FDA at 1-800-FDA­
`
`1088 or www.fda.gov/medwatch
`
`
`
`----------------------------DRUG INTERACTIONS-------------­
`-------------------
` • Nephrotoxic agents including NSAIDs: Renal reactions
`
`
` have been reported (7.1)
` • Azathioprine or 6-mercaptopurine: Blood disorders have
`
`
`
` been reported (7.2)
`
`------------------------USE IN SPECIFIC POPULATIONS----------------------­
`
`
` • Renal Impairment: Use DELZICOL with caution in patients with a history
`
`
`
`
`
` of renal disease (5.1, 7.1, 8.6)
`
`• Geriatric Patients: Monitor blood cell counts in geriatric patients (8.5)
`
`
`
`
`
`
`
`
`
`
`See 17 for PATIENT COUNSELING INFORMATION.
`Revised 10/2014
`
`
`
`_____________________________________________________________________________________
`6
`ADVERSE REACTIONS
`
`FULL PRESCRIBING INFORMATION: CONTENTS*
`
`
`
`
`6.1
`Clinical Trials Experience
`
`1
`INDICATIONS AND USAGE
`
`
`
`6.2
`Postmarketing Experience
`
`
`
`
`Treatment of Mildly to Moderately Active Ulcerative Colitis
`1.1
`
`DRUG INTERACTIONS
`
`
`1.2
`Maintenance of Remission of Ulcerative Colitis in Adults
`
`Nephrotoxic Agents, Including Non-Steroidal Anti-
`7.1
`
`DOSAGE AND ADMINISTRATION
`
`Inflammatory Drugs
`
`
`
`
`
`Dosage for Treatment of Mildly to Moderately Active
`2.1
`
`
`Azathioprine or 6-mercaptopurine
`7.2
`
`Ulcerative Colitis
`USE IN SPECIFIC POPULATIONS
`
`Dosage for Maintenance of Remission of Ulcerative Colitis
`
`
`
`8.1
`Pregnancy
`
`in Adults
`
`
`8.3
`Nursing Mothers
`
`
`Important Administration Instructions
`2.3
`
`
`8.4
`Pediatric Use
`
`
`
`
`Testing Prior to DELZICOL Administration
`2.4
`
`
`Geriatric Use
`8.5
`DOSAGE FORMS AND STRENGTHS
`
`
`
`8.6
`Renal Impairment
`CONTRAINDICATIONS
`
`OVERDOSAGE
`
`WARNINGS AND PRECAUTIONS
`
`
`DESCRIPTION
`
`
`
`5.1
`Renal Impairment
`
`CLINICAL PHARMACOLOGY
`
`
`
`
`5.2
`Mesalamine-Induced Acute Intolerance Syndrome
`
`
`
`12.1
`Mechanism of Action
`
`
`5.3
`Hypersensitivity Reactions
`
`
`12.3
`Pharmacokinetics
`
`
`5.4
`Hepatic Failure
`NONCLINICAL TOXICOLOGY
`
`
`
`
`
`5.5
`Prolonged Gastric Retention in Patients with Upper
`
`
`
`
`Carcinogenesis, Mutagenesis, Impairment of Fertility
`13.1
`
`
`Gastrointestinal Obstruction
`
`
`13.2
`Animal Toxicology and/or Pharmacology
`
`
`
`
`
`
`2.2
`
`
`2
`
`3
`
`4
`
`5
`
`
`
`7
`
`8
`
`
`10
`
`11
`
`12
`
`
`13
`
`
`
`
`Reference ID: 3649013
`
`
`
` 1
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 15
`
`

`
`Case 2:15-cv-01740-JRG-RSP Document 1-1 Filed 11/09/15 Page 3 of 17 PageID #: 16
`
`
`
` 14
`
`
`
`
` CLINICAL STUDIES
`
` Treatment of Mildly to Moderately Active Ulcerative Colitis
`
`
` 14.1
`
`
`14.2
`Maintenance of Remission of Ulcerative Colitis
`
`
`
`*Sections or subsections omitted from the full prescribing information are not listed.
`__________________________________________________________________________________________
`
`
` 16
`
` 17
`
`
` HOW SUPPLIED/STORAGE AND HANDLING
`
` PATIENT COUNSELING INFORMATION
`
`
`
`Reference ID: 3649013
`
`
`
` 2
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 16
`
`

`
`Case 2:15-cv-01740-JRG-RSP Document 1-1 Filed 11/09/15 Page 4 of 17 PageID #: 17
`
`
`
`
`
`
`
` FULL PRESCRIBING INFORMATION
`
` 1 INDICATIONS AND USAGE
`
`
`
` 1.1 Treatment of Mildly to Moderately Active Ulcerative Colitis
`
`
`
`
` DELZICOL® (mesalamine) delayed-release capsules are indicated for the treatment of mildly to
`
`
` moderately active ulcerative colitis in patients 12 years of age and older.
`
`
` 1.2 Maintenance of Remission of Ulcerative Colitis in Adults
`
`
`
`
` DELZICOL® (mesalamine) delayed-release tablets are indicated for the maintenance of remission of
`
`
`
`
` ulcerative colitis in adults. The safety and effectiveness of DELZICOL for the maintenance of remission
`
`
`
`
`
` of ulcerative colitis in pediatric patients have not been established.
`
`
`
`
`
`
`
`
`
` 2 DOSAGE AND ADMINISTRATION
` 2.1 Dosage for Treatment of Mildly to Moderately Active Ulcerative
`
`
` Colitis
`
`
`
`
`
` Adults
`
` For adults, the recommended dosage of DELZICOL is two 400 mg capsules to be taken three times daily
`
`
`
`
`
`
`
` with or without food (total daily dose of 2.4 grams), for a duration of 6 weeks [see Clinical Studies
`
`(14.1)].
`
`
`
`Pediatrics
`
`
`
`For pediatric patients 12 years of age and older, the recommended total daily dose of DELZICOL is
`
`
`
`weight-based (up to maximum of 2.4 grams/day). DELZICOL capsules are to be taken twice daily with
`or without food for a duration of 6 weeks [see Clinical Studies (14.1)].
`
`
`
` Pediatric Dosage by Weight
`
`
`Weight Group
`Daily Dose
`
` (mg/kg/day)
`
` (kg)
`
` 17 to <33
`
` 36 to 71
`
` 33 to <54
`
` 37 to 61
`
`
` 27 to 44
` 54 to 90
`
`
`
` Maximum Daily Dose
` (grams/day)
`
`
` 1.2
`
` 2.0
`
` 2.4
`
`
` 2.2 Dosage for Maintenance of Remission