CENTER FOR DRUG EVALUATION AND
`RESEARCH
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`APPLICATION NUMBER:
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`207620Orig1s000
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`ADMINISTRATIVE and CORRESPONDENCE
`DOCUMENTS
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`Form Approved: OMB No. 0910-0513
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`Department of Health and Human Services
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`Expiratlon Date: 10l31l2016
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`Food and Drug Administration
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`See OMB Statement on Page 3.
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`PATENT INFORMATION SUBMITTED WITH "THE FILING
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`NBA UMBER
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`OF AN NBA, AMENDMENT, 0R SUPPLEMENT
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`For Each Patent That Claims a mug Substance
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`(Active lngredient}, Drug Product (Formulation and Composition)
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`anrflor Method of Use
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`. NTINDA ‘OLDER
`NA E OF APPLI
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`Novartis Pharmaceuticals Corporation
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`The following is provided in accordance with Section 505(1)) and (c) of the Federal Food, Drug, and Cosmetic Act.
`T ' DE NAME (OR PROPOSED TRADE NAME)
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`To Be Determined
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`sraervernrsr
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`50mg, 100mg, 200mg (sacubitrih’valsartan)
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` This patent declaration form is required to be submitted to the Food and Drug Administration {FDA} 1with an NBA application,
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`amendment, or supplement as required by 21 CFR 314.53 at the address provided in 21 CFR 314.53id}(4}.
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`Within thirty (30) days after approval or an MBA or supplement. or within thirty (30) days of issuance of a new patent. a new patent
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`deciaration must be submitted pureuantio 21 CFR 314.53tc}(2}(ii) with all of the required information based on the approved MBA or
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`supplement The information submitted in the declaration iorrn submitted upon or after approval will be the cniy lnfomration relied
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`upon by FDA for listing a patent in the Orange Book.
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`For hand-written or typewriter verslons (only) of this report: if additional space is required for any narrative answer lie, one that
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`does not require a "Yes" or "No" response). Please attach an additional page referencing the question number.
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`FDA will not list patent information if you submit an incompiete patent declaration or the patent declaration indicates the
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`parent is not eligible for listing.
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`For each parent submitted for the pending NBA, amendment, or supplement referenced above, you must submit all the
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`information described below. if you are not submitting any patents for this pending NBA, amendment, or supplement,
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`complete above section and sections 5 and 6.
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`- 1. GENERAL
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`a. Unlted States Patent Number
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`in. Issue Date of Paton
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`Ad-ress (ofPalenl Iwner)
`d. Name 0 atent I
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`Lichtstrasse 35 CHAOSG Basel Switzerland
`Novartis AG
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`Citylstate
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`FAX Number {ifavar'iable}
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`I 0114161324 3001
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`e. ‘ameo agar-r orrepiT'fisen owe
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`nited Slates anthorized to
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`receive notice of patent certification under section 505(b}(3}
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`and thxB) of'the Federal Food. Drug. and Cosmetic Act
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`and 21 CFR 314.52 and 314.95 (if patent owner or NDA
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`appiicanllholder does not reside or have a place of
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`business within the United States)
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`" - me
`“ 1“ Wumrfifavar‘leole)
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`ephone um-r
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`862-778-8300
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`. St a patent re erence. a. we a patent! t as been su-mitte prevrouay or he
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`approved NDA or supplement referenced above?
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`date a new expiration date?
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`FORM FDA 3542a (11:13)
`Page 1
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`PEG PUNflbIrlg Sen-nu um; «ii-om EI‘
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`or
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`c. Exoiral on Date of Patent
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`[:| Yes
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`E No
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`Reference ID: 3791157
`Reference ID: 3791157
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`For the patent referenced above, provide the following infannation on the drug substance, drug product and/or method of
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`use that is the subject of the pending NDA, amendment or supplement
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`2.311% Substance (Active ingrodlont)
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`2.1 Does the patent claim the drug substance thatIs the active ingredient in the drug product
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`desoribod'in the pending NEDA. amendment. or supplement?
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`2.2 Does the patent claim a (rug substance ihaiis a different polymorph of the active
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`ingredient described in the pending NBA. amendment. or supplement?
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`2-3 ifthe answer 10 Question 2.2 is ”Yes," do you oertify that. as of the date of this declaration. you have test
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`data demonstrating that a drug product containing the poiymorph will perform the some as the drug product
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`described in the NBA? The type attest data required is described at 21 CFR 314.53(b).
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`[:3 Yes
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`2.4 Specify the poiymorphlo formis) claimed by the patent for Which you have the test results described in 2.3.
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`2.5 Does the patent claim only a metabolite of the active ingredient pending in the NDAor supplement?
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`(Complete the information‘In section 4 below if the patent claims a pending method of using the pending
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`drug produotto administer the metabolite.)
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`D Yes
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`No
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`2.6 Does the patent oiaim only an intermediate?
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`2.? if the patent referenced in 2.1 is a produ ct-by-proooss patent. is the product defined in the
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`patent novel? (An answer is required only tithe patent is a produci—by-procoss patent.)
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`3. Drug Product (Compositioanonnulatlon)
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`3.1 Does the patent oiaim the drug product. as defined in 21 CFR 314.3. in the pending NBA, amendment.
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`or supplement?
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`3.2 Does the potent claim oniy an intermediate?
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`3.3 if the patent referenced in 3.1 is a pmdlmi—byprocess patent. is the product oiaimed in the
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`patent novel? {An answer is required only it the patent is a product-hypmoess patent.)
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`I] Yes
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`4. Method of Use
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`Sponsors must submit the information in section 4 for each method of using the pending drug product for which approval is being
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`sought that is defined by the patent. For each pending method of use claimed by the patent, provide the following information:
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`4.1 Does the patent claim one or more methods of use for which approval is being sought in
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`the pending NBA. amendment. or supplement?
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`E] Yes
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`tines (Do) the patent olalmts) referenced in 4.2 claim a
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`pending method of use for which approval is being sought
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`[j Yes
`1:] No
`in the pending NBA. amendment. or supplement?
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`4.2a lithe answerto 4.2 is
`Use: (Submit indication or method of use information as identified spocfiootfy in the proposed labeling.)
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`"Yes," identify with speci-
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`ficity the use with refer-
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`ence to the proposed
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`iaoeling for the drug
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`product.
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`4.2 Patent Claim Numberts) {as listed in the patent)
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`5. No Relevant Patents
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`For this pending NDA, amendment. or supplement. there are no reievantpatenls that claim the drug substance (active ingredient).
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`drug product (formulation or oomposflr'on) or methocks) of use, for which the applicant is seeking approval and with respect to which
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`a_ olairn of patent infringement could reasonably be asserted it a person not licensed by the owner of the patent engaged in the
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`manufacture, use. or sale ofthe drug product.
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`FORM FDA 35423 [11i13)
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`Reference ID: 3791157
`Reference ID: 3791157
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`6.2 Authorized Signature of NBA ApplicantiHolcier or Patent Owner (Attorney. Agent, Representative or
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`other Authoriggd Officr‘ai) (Provide lnfonnation below)
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`6. Declaration Certification
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`6.1 The undersigned declares that this is an accurate and complete submission of patent information for the NDA.
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`amendment, or supplement pending under section 505 of the Federal Food, Drug, and Cosmetic Act. This time-
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`sensitive patent information is submitted pursuant to 21 CFR 314. 53. latest that i am familiar with 21 CFR 314.53 and
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`this submission complies with the requirements of the regulation. l verify under penalty ofperjury that the foregoing is
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`true and correct.
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` Warning: A willfully and knowingly false statement is a criminal offense under 18 U.S.C. 1001.
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`Date Signed
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`foéfieex
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`Authorized Official
`{:3 NBA Applicant'sil-lotder‘s Attorney, Agent (Representative) or other
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` El Patent Owner‘s Attorney Agent (Representative) or Other Authorized
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`David Kurlandsky
`Address
`7 CltylState
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`One Health Plaza
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`East Hanover, New Jersey
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`up one Number
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`862478-5896
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`E-Mail Address (if available)
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`973-781—8064
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`david.kurlandsky@novartis.oom
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`This section applies only to requirements of the Paperwork Reduction Act 01‘1995,
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`“DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADbRESS BELOW."
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`The burden time for this coilection of information is estimated to average 20 hours per response, including the time to
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`review instructions, search existing data sources, gather and maintain the data needed and complete and review the
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`collection of information. Send comments regarding this burden estimate or any other aspect of this information collection,
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`including suggestions for reducing this burden, to:
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`PRASrafififda.irks,gov
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` "An agency may not conducr or sponsor. and a person is nor required to respond to, a collection of
`lnfonnotlon unless it displays a currently valid OMB number. "
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`FORM FDA 3542a (11113)
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`Page 3
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`Reference ID: 3791157
`Reference ID: 3791157
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`

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`I INFORMATION AND INSTRUCTIONS FOR FORM 3542a
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`PATENT INFORMATION SUBMITTED WITH THE FILING
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`OF AN NBA, AMENDMENT OR SUPPLEMENT
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`16} Answer this question if applicable. If patent owner and NBA
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`applicant/holder reside in the United States, leave space
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`blank.
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`2.5) A patent for a metabolite ofthe approved active ingredient
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`metabolite, the patent may be submitted as a method of use
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`General Information
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`liorm 3542a should be used when submitting patent information
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`supplements prior to approval.
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`Form 3542 should be used allot NDA or supplement approval.
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`This focm is to be submitted within 30 days afler approval ofan
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`information relating to an approved supplement under 2] CFR
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`3 l4.53(d) to change the formulation, add a new indication or
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`approval. Patents issued after dmg approval are required to be
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`_ submitted within 30 days of patent issuance for the patent to be -
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`considered "timely filed. "
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`Only information from Form 3542 will be used for Orange Book
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`Forms should be submitted as described in 21 CFR. 314.53.
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`Sending an additional copy of form 3542 to the Orange Book
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`Staff will expedite patent publication in the Orange Book. The
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`Orange Book Staff address (cs of April 2007) is: Orange Book
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`Staff, Office of Generic Drugs OGDI'HF13-610, 7620 Standish
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`Place, Rockvillc, MD 20855.
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`The receipt date is the date that the patent information is date
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`stamped in the centre] document room. Patents are considered
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`listed on the date received.
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`‘ Additional copies ofthese forms may be downloaded from the
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`Internet at: http:/fu'wwfdagov/apneamfmarechor‘ces/fdafirmr/
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`fa'aformerme
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`First Section
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`Complete all items in this section.
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`1. General Section
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`Complete all items in this section with reference to the patent
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`1c) Include patent expiration date. including any Hatch-Waxman
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`patent extension olrcady'grantcd. Do not include any
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`applicable pediatric exclusivity, The agency will include
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`pediatric exclusivities where applicable upon publication.
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`describes the authorized signature.
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`4. Method of Use
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`use of the drug product that is the subject of the pending NDA,
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`amendment, or supplement {pending method of use).
`4.2) For each pending method of use claimed by the patent;
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`identify by number the claim(s) in the patent that claim the
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`pending use of the drug. An applicant may list together
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`multiple patent claim numbers and information fur each
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`pending method of use, if applicable. However. each
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`pending method of use must be separately listed within this
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`section ol'the form.
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`4.2a) identity the precise words ofthe approve] labeling that
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`describe with specificity the patented method ofuse.
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`5. No Relevant Patents
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`Complete this section only ifapplicablc.
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`6. Declaration Certification
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`it!) Include Full address of patent owner. if patent owner resides
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`outside the US. indicate the country in the zip code black.
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`6.2) Authorized signature. Check one ofthe four boxes that best
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`FORM FDA 354211 (11113)
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`Page 4
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`Reference ID: 3791157
`Reference ID: 3791157
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`Department of Health and Human Services
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`Food and Drug Administration
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`PATENT ENFORMATION SUBMITTED WiTH THE FILING
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`OF AN NBA, AMENDMENT, OR SUPPLEMENT
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`For Each Patent That Claims a Drug Substance
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`(Acrrve Ingredient), Drug Product (Fonnularion and Composition)
`andl'or Method of Use
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`Form Approved: OMB No. 0910-0513
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`Expiration Date: i0l31l2mfi
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`See OMB Slatement on Page 3.
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`N‘Wams Phamceum‘s Cmm‘m
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`The following is provided in accordance with Section 505m and (c) of the Federal Food, Drug, and Cosmetic Act.
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`TRADE NAME (OR PROPOSED TRADE NAME)
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`To Be Determined
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`ACTIVE iNGREDlENTiS
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`(sacuhitrillvalsartan)
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`STRENGTH(S)
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`50mg, 100mg, 200mg
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`This patent declaration form is required to be submitted to the Food and Drug Administration (FDA) with an NBA application.
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`amendment, or supplement as required by 21 CFR 314.53 at the address provided in 21 CFR 314.53id)(4).
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`Within thirty (39) days after approval of an NBA or supplement. or within thirty {30) days of issuance of a new patent, or new patent
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`declaration must be submitted pursuantto 21 CFR 314.53icii2xii} with all of the required information based on the approved MBA or
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`upon by FDA for listing a patent in the Orange Book.
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`For hand-written or typewriter versions (only) of this report: If additional space is required for any narrative answer (is... one that
`does not require a "Yes" or “No“ response]. please attach an additional page retarencing the question number.
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`FDA will not list patent information ifyou submit an incomplete patent declaration or the patent declaration indicates the
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`patent is not eligible for listing.
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`For each patent submitted for the pending NBA, amendment. orsupplement referenced above, you must submit all the
`information desarlbed below. if you are not submitting any parents for this pending NDA, amendment. or supplement,
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`complete above section and sections 5 and 6.
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`1. GENERAL
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`a. United States slant umber
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`8,181,659
`d. Name of Patent Owner
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`Novartis AG
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`b. issue Date of Patent
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`January 24, 2012
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`Address {of Patent Owner)
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`Lichtstmsse 35 (EH-4056 Basel Switzerland
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`6. Expiration Date of Patent
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`January 14, 2023
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`E—Mail Address (ifevailabie)—_
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`3 -p one ‘
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`ten previousy ori -
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`" Var dress {i aveiable)
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`1:] Yes
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`niled States authorized to
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`receive notice of patent codification undersection 505(b}(3)
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`and 21 CFR 314.52 and 314.95 or patent owner or NDA
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`applicantlhoider does not reside or have a place of
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`approved NDA or supplement referenced above?
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`- date a new expiration date?
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`FORM FDA 3542a (11l13)
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`Reference ID: 3791157
`Reference ID: 3791157
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`For the patent referenced above, provide the foiiowiny information on the drug substance, drug product endior method of
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`use that is the subject of the pending NBA, amendment, or supplement
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`2. Drug Substance (Active Ingredient)
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`2.1 Does the patent claim the drug substance that"Is the adiva ingredient'in the drug product
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`described'In the pending NDA. amendment. or supplement?
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`1:; yes.
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`2.3 if the answer to question 2.2 is "Yes." do you certify that. as cfthe date of this declaration. you have lost
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`dais demonstrating that a drug product containing the potymorph will perform the same as the drug product
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`described in the NBA? The type of lest data required is described at 21 CFR 314.5361).
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`2.4 Specify the polymorphic form(s) claimed by the patent for which you have the test results desonhad in 2.3.
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`2.2 Does the patent claim a drug substance thatis a different poiyrnurph ottho actiure
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`ingredient described in the pending NDA. amendment. or swplomant?
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`2.5 Does the patent claim only a metabolite of the active Ingredient pending in the NDA or supplement?
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`(Con-Iplele the information in section 4 below if the patent claims a pending method of using the pending
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`drug product to administerthe metabolite.)
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`3. Drug Product [CompositioniFonnulatiom
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`3.1 Doesthe patent claim the drug product. as defined in 21 CFR 314.3, In the pending NDA. amendment,
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`or supplement?
`Yes
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`3.2 Does the patent claim only an intermediate?
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`DYes
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`3.3 If the patent referenced in 3.1 is a product-by—process patent. is the product claimed in the
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`patem novel? (An answer is required only it the patent Is a product-by—process patent.)
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` Sponsors must submit the information in section 4 for each method ofusing the pend‘mg drug product for which approval is being
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`sought that is claimed by the patent. For each pending method of use claimed by the patent, provide the following information:
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`4.1 Does the patent claim one or more methods of use for which approval ls being sought in
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`the pending NBA. amendment. or supplement?
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`{.2 Patent Claim Numhefls) (as iisiecl in the patent)
`Does (Do) the patent claimts} referenced In 4.2 claim a
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`pending method of use for which approval is being sought
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`in the pending NBA. amendment, or supplement?
`I] Yes
`[3 No
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`Use: (Submit indication or method of use inicnnation as identified specificoiiy in the Proposed labeling.)
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`"You." idoniliy with specie
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`ficity the use with tater-
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`enoe to the proposed
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`labeling for the drug
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`product.
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`' as Does the patent claim only an intermediate?
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`2.? if the patent referenced in 2.1 is a product-by-process patent. is the product claimed in the
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`patent novel? (An answer is required only ifthe patent is a product-impresses patent.)
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`' [:3 Yea
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`C] No
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`5- No Relolrant Patients
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`For this pending NBA. amendment. or supplement, there are no relevant patents that claim the drug substance (active ingredient).
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`dnzg product (formulation or composition) or meihodts) of use. for Mitch the applicant is seeking approval and with respect to which
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`a claim of patent infringement could reasonably be asserted it a person not licensed by the owner ofthe patent engaged In the
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`manufacture use. or sale of the drug product.
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`FORM FDA 3542a [11H 3}
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`Page 2
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`Reference ID: 3791157
`Reference ID: 3791157
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`

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`I 6. Declaration Certification
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`6.1 The undersigned declares that this is an accurate and complete submission ofpatent information for the NDA.
`amendment, or supplement pending under section 505 of the Federai Food, Drug, and Cosmetic Act. This time-
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`sensitive patent information is submitted pursuant to 21 CFR 314.53. iattest that i am famiiiar with 21 CFR 314.53 and
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`this submission compiies with the requirements of the regulation. I verify under penalty of perjury that the foregoing is
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`true and correct.
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`Warning: A wiiifuil‘y and knowingiy fame statement is a criminal offense under 18 U3. C. 1001.
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`Authorized Signature of NBA Applicantit-toider or Patent Owner (Niamey, Agent. Representative or
`other/Authorized Official) (Provide i omrarion beiow)
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`mmng
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`Date'Signe-d
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`f H x
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`Alf/gig/§:ff;§f V
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`taration directly to the FDA. A patent owner who is not the NDA applicant!
`NOTE: Only an NBA applicanuhordér may submit this L
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`holder is authorized to sign the declaration but may not submit it directiy to FDA. 21 CFR 314.53(c)(.4) and (own.
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`Check applicabie box and provide information below.
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`informairon mics: r‘r dr‘splafir a currently valid OMB number. "
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`Cl NDA Applicant’siHotder‘s Attorney. Agent (Representative) or other
`D NDA ApplicanliHolder
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`Authorize d Oificiai
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`8 Patent Owner‘s Attorney. Agent (Representative) or Other Authorized
`E] Patent Owner
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`Officiai
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`Name
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`David Kurtandsky
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`Address
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`One Health Plaza
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`CityiState
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`East Hanover, New Jersey
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`' lP Code
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`07936
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`FAX Number (if avaiiabie}
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`973-781-8064
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`TelephonENumber
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`862-778—5806
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`E—Mail Address (if availabie}
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`david.kurlandsky@uovartis.com
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`This section applies only to requirements of the Paperwork Reduction Act of 1995.
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`*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.“
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`The burden time for this collection of informanon is estimated to average 20 hours per rcslaonsc, including the time to
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`review instructions, search existing data sources. gather and maintain the date needed and complete and rcvrcw the
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`COllctrtlon of information Send comments regarding this burden estimate or any other impact of this information collection,
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`including suggestions for reducing this burden, £0:
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`Department of Health and Human Services
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`Food and Drug Administration
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`Office of Chief Information Officer
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`Paperwork Reduction Act (PRA) Staff
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`PMS:afl@fda.hhr.gor
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`"Ari agency may not conduct or Sponsor. and a person is not required to respond in, a coiiecil'on of
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`FORM FDA 35423 (11113)
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`'
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`Page 3
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`Reference ID: 3791157
`Reference ID: 3791157
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`

`

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`iNFORMATlON AND INSTRUCTIONS FOR FORM 3542a
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`PATENT INFORMATION SUBMITTED WITH THE FILING
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`OF AN NBA, AMENDMENT DR SUPPLEMENT-
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`1e) Answer this question if applicable. if patent owner and NDA
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`applicantfholder reside in the United States, leave space
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`blank.
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`2. Drug Substance (Active Ingredient)
`Compiete all items in this section if the patent claims the drug
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`substance that is the subject of the pending NDA, amendment, or
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`supplement.
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`2.4} Name the polymorphic form of the drug identified by the
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`patent.
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`2.5) A patent for a metabolite ofthe approved active ingredient
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`may not be submitted. Ifthe patent claims no approved
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`method ofusing the approved drug product to administer the
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`metabolite, the patent may be submitted as a method of use
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`patent depending on the responses to section 4 ot‘this form.
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`Answer this question only {Ithe patent is a product-by-
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`process patent.
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`describes the authorized signature.
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`General information
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`' To submit patent information to the agency the appropriate
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`patent declaration form must be used. Two forms are available
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`for patent submissions. The approval status ofyour New Drug
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`Application will determine which form you should use.
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`Form 3542a should be used when submitting patent information
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`with original NBA submissions, NDA amendments and NBA
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`supplements prior to approvai.
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`Form 3542 should be used after NDA or supplement approval.
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`This form is to be submitted within 30 days after approvai of an
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`application. This form should also be used to submit patent
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`information relating to an approved supplement under 21 CFR
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`314.53(d) to change die formulation, add a new indication or
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`other condition of use. change the strength. or to make any other
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`patented change regarding the drug, drug product, or any
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`method of use.
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`Form 3542 is also to be used for patents issued nfier drug
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`approvat. Patents issued alter drug approval are required to be
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`submitted within 30 days of patent issuance for the patent to be
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`considered "timely tiled."
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`Only information from form 3542 will be used for Orange Book
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`publication purposes.
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`Forms should be submittedas described in 21 CFR 314.53.
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`Sending an additional copy of form 3542 to the Orange Book
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`St