`Protecting and Promoting Your Health
`
`Small Business Assistance:
`Frequently Asked Questions for New
`Drug Product Exclusivity
`
`1. What is new drug product exclusivity?
`
`New Drug Product Exclusivity is provided by the Federal Food, Drug, and Cosmetic Act under
`section 505(c)(3)(E) and 505(j)(5)(F). Exclusivity provides the holder of an approved new drug
`application limited protection from new competition in the marketplace for the innovation
`represented by its approved drug product. This limited protection precludes approval of certain 505
`(b)(2) applications or certain abbreviated new drug applications (ANDAs) for prescribed periods of
`time. Some exclusivity provisions also provide protection from competition by delaying the
`submission of 505(b)(2) applications and ANDAs for certain periods of time. Exclusivity is available
`for new chemical entities (NCEs), which by definition are innovative, and for significant changes in
`already approved drug products, such as a new use. New drug product exclusivity includes two
`categories of exclusivity (described in Q & A #6) both NCE and "other significant changes"
`exclusivity.
`
`2. Why is new drug product exclusivity also known as the Hatch/Waxman exclusivity?
`
`On September 24, 1984 the President signed into law the Drug Price Competition and Patent Term
`Restoration Act of 1984 (Hatch/Waxman Amendments). Title 1 of the Hatch/Waxman Amendments
`amended the Federal Food, Drug, and Cosmetic Act (the Act) to expand the universe of drugs for
`which FDA would accept ANDAs. The Hatch/Waxman Amendments also provided for New Drug
`Product Exclusivity and are often referred to as Hatch/Waxman exclusivity since Senator Hatch
`and Congressman Waxman sponsored the amendments in Congress to encourage research and
`development, as well as to speed entry of generic drugs into the market.
`
`3. What is a 505(b)(2) application?
`
`A 505(b)(2) application is one described under section 505(b)(2) of the act as an application for
`which one or more of the investigations relied upon by the applicant for approval "were not
`conducted by or for the applicant and for which the applicant has not obtained a right of reference
`or use from the person by or for whom the investigations were conducted" (21 U.S.C. 355(b)(2)).
`This provision expressly permits FDA to rely for approval of an NDA, on data not developed by the
`applicant such as published literature or the agency’s finding of safety and effectiveness of a
`previously approved drug.
`
`505(b)(2) applications are submitted under section 505(b)(1) of the act and are therefore subject to
`the same statutory provisions that govern 505(b)(1) applications that require among other things,
`"full reports" of safety and effectiveness.
`
`4. What is an abbreviated new drug application (505)(j)?
`
`CFAD Exhibit 1070
`CFAD v. NPS
`IPR2015-01093
`
`http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm069962.htm
`
`1
`
`
`
`An abbreviated new drug application is described under section 505(j) of the Act as an application
`that contains information to show that the proposed product is identical in active ingredient, dosage
`form, strength, route of administration, labeling, quality, performance characteristics and intended
`use, among other things to a previously approved application (the reference listed drug (RLD).
`ANDAs do not contain clinical studies as required in NDAs but are required to contain information
`establishing bioequivalence to the RLD. In general, the bioequivalence determination allows the
`ANDA to rely on the agency’s finding of safety and efficacy for the RLD.
`
`5. What is a full new drug application 505(b)(1)?
`
`A 505(b)(1) application is described by section 505(b)(1) of the act as an application that contains
`full reports of investigations of safety and effectiveness, in addition to other information. The data
`in the application is either owned by the applicant or is data for which the applicant has obtained a
`right of reference.
`
`6. What are the time periods of new drug product exclusivity?
`
`A 5-year period of exclusivity is granted to new drug applications for products containing chemical
`entities never previously approved by FDA either alone or in combination. No 505(b)(2) application
`or ANDA may be submitted during the 5-year exclusivity period except that such applications may
`be submitted after 4 years if they contain a certification of patent invalidity or noninfringement. A
`3-year period of exclusivity is granted for a drug product that contains an active moiety that has
`been previously approved, when the application contains reports of new clinical investigations
`(other than bioavailability studies) conducted or sponsored by the sponsor that were essential to
`approval of the application. For example, the changes in an approved drug product that affect its
`active ingredient(s), strength, dosage form, route of administration or conditions of use may be
`granted exclusivity if clinical investigations were essential to approval of the application containing
`those changes.
`
`7. What is the definition of a "new clinical investigation"?
`
`FDA interprets "new clinical investigation" as an investigation in humans, the results of which (1)
`have not been relied upon by FDA to demonstrate substantial evidence of effectiveness of a
`previously approved drug product for any indication or of safety in a new patient population and (2)
`do not duplicate the results of another investigation relied upon by FDA to demonstrate a
`previously approved drug’s effectiveness or safety in a new patient population. A clinical
`investigation that provides a "new" basis for approval of an application can qualify for exclusivity. In
`this context, "new" is intended to convey a lack of prior use of a clinical investigation rather than
`any temporal requirement.
`
`8. What is the definition of a "new chemical entity"?
`
`A new chemical entity means a drug that contains no active moiety that has been approved by
`FDA in any other application submitted under section 505(b) of the Act.
`
`9. What is the definition of an "active moiety"?
`
`An active moiety means the molecule or ion, excluding those appended portions of the molecule
`that cause the drug to be an ester, salt (including a salt with hydrogen or coordination bonds), or
`other noncovalent derivative (such as a complex, chelate, or clathrate) of the molecule,
`responsible for the physiological or pharmacological action of the drug substance.
`
`http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm069962.htm
`
`2
`
`
`
`10. What is the definition of "Conducted or sponsored by the applicant"?
`
`An investigation conducted or sponsored by the applicant means that before or during the
`investigation, the applicant was named in Form FDA 1571 filed with FDA as the sponsor of the
`investigational new drug application under which the investigation was conducted, or the applicant
`or the applicant’s predecessor in interest, provided substantial support for the investigation. An
`applicant who has purchased exclusive rights to a study should be able to obtain new drug product
`exclusivity. Applicants cannot qualify for exclusivity by simply collecting and submitting to FDA
`information from the literature or buying the results of tests already done and submitting them to
`FDA without obtaining exclusive rights for those tests.
`
`11. What types of applications can receive 5 year and 3 year periods of exclusivity?
`
`Full new drug applications under 505(b)(1) and 505(b)(2) can receive 5 years of exclusivity for a
`new chemical entity drug product. A 505(b)(1), 505(b)(2) application or a supplement to a new drug
`application can receive 3 years of exclusivity.
`
`12. Is the original applicant required to conduct the complete study to obtain exclusivity?
`
` No, FDA interprets the Act to allow for exclusivity where the applicant has conducted or sponsored
`the study by providing 50 percent of the funding or by purchasing exclusive rights to the study.
`
`13. Do the new drug product exclusivity provisions of the Act provide any protection from
`the marketing of a duplicate version of the same drug product if the duplicate version is the
`subject of a full new drug application submitted under 505(b)(1) of the Act?
`
`No, the new drug product exclusivity provisions do not provide any protection under these
`conditions.
`
`14. Are there other types of exclusive marketing available?
`
`Yes, there is orphan drug exclusivity, pediatric exclusivity, 180-day generic drug exclusivity, and
`patent protection (For an explanation of orphan drug exclusivity, pediatric exclusivity, and patent
`term extension/also referred to as patent term restoration. See the Small Business Assistance:
`Economic Assistance and Incentives (/Drugs/DevelopmentApprovalProcess/SmallBusi-
`nessAssistance/ucm069929.htm) web page.
`
`15. Can the six months of pediatric exclusivity be added to the 5 or 3 years of new drug
`product exclusivity?
`
`Yes, pediatric exclusivity is the only exclusivity that runs from the end of other exclusivity protection
`(New Drug Product and Orphan Drug) or patent protection. A six-month pediatric exclusivity that
`attaches after a patent term is not a patent extension; it is a FDA-enforced exclusivity period that
`begins at the termination of the patent.
`
`16. How do you apply for New Drug Product Exclusivity?
`
`There is no requirement to apply. The Center for Drug Research and Evaluation (CDER) makes
`exclusivity determinations on all relevant applications. There is a procedure in CDER that provides
`review of all relevant applications, with or without a request from the applicant, for an exclusivity
`determination.
`
`http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm069962.htm
`
`3
`
`
`
`17. Where do you find information on drugs that have received New Drug Product
`Exclusivity?
`
`The Orange Book & Supplements/Electronic Orange Book, has an addendum with patent and
`exclusivity information. The Orange Book, Approved Drug Products with Therapeutic Equivalence
`Evaluations,identifies drug products approved on the basis of safety and effectiveness by the Food
`and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act. See the
`electronic Electronic Orange Book (http://www.accessdata.fda.gov/scripts/cder/ob/de-
`fault.cfm).
`
`18. Where do you find the regulations for New Drug Product Exclusivity?
`
`The regulations are at 21 CFR 314.108 (http://frwebgate.access.gpo.gov/cgi-bin/get-cfr.cgi?TI-
`TLE=21&PART=314&SECTION=108&YEAR=2001&TYPE=TEXT).
`
`More in CDER Small Business and Industry Assistance
`(/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/default.htm)
`
`2015 REdl: Generic Drugs Forum
`(/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm435895.htm)
`
`2014 GDUFA and You Conference
`(/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm386570.htm)
`
`2013 GDUFA and You Conference
`(/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm351382.htm)
`
`CDER Small Business and Industry Assistance (SBIA) Regulatory Education for Industry (REdI)
`Conference "Prescription Drug Labeling - Challenges and Issues
`(/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm465115.htm)
`
`FDA Small Business Regulatory Education for Industry (REdI) Conference Fall 2013
`(/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm364584.htm)
`
`FDA Small Business Regulatory Education for Industry (REdI) Conference Spring 2014
`(/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm396875.htm)
`
`FDA Small Business Regulatory Education for Industry (REdI) Conference Spring 2015
`(/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm440627.htm)
`
`FDA Small Business Regulatory Education for Industry (REdI): Generic Drugs Forum 2016
`(/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm487373.htm)
`
`FDA Small Business and Industry Assistance Regulatory Education for Industry (REdI) Conference
`Fall 2014 (/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm409987.htm)
`
`General Information on CDER Small Business and Industry Assistance (CDER SBIA)
`(/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm053133.htm)
`
`Small Business and Industry Education Series
`(/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm345107.htm)
`
`http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm069962.htm
`
`4
`
`
`
`http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm069962.htm
`
`5