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Published on January 12, 2009

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Exclusivity - Pediatrics - 505(b)(2)s : Exclusivity - Pediatrics - 505(b)(2)s Leanne Cusumano Regulatory Counsel Center for Drug Evaluation and Research 301-594-2041pdit@cder.fda.gov FDA What is exclusivity? : What is exclusivity? Exclusivity is marketing protection. Exclusivity prevents the marketing of an identical generic or 505(b)(2) product for a certain period of time (all 505 blocked by orphan) Exclusivity is enforced by FDA Exclusivity prevents either the submission or approval of an application How many types of exclusivity are there? : How many types of exclusivity are there? Hatch-Waxman New molecular entity - 5 year New use - 3 year applications supplements 1st filed ANDA - 180 day marketing Orphan Drug Exclusivity - 7 year Pediatric Exclusivity What is pediatric exclusivity? : What is pediatric exclusivity? Pediatric exclusivity is an incentive developed by Congress to encourage sponsors to conduct pediatric studies. Pediatric exclusivity does not stand alone - it attaches only to existing exclusivity or patents. Effect of Pediatric Exclusivity : Effect of Pediatric Exclusivity attaches to exclusivity or patent life of the active moiety as EXCLUSIVITY extension adds 6 months of exclusivity possible delay of generic approvals once submitted, maximum of 90 days six month period runs during delay Applications to Which Pediatric Exclusivity Applies : Applications to Which Pediatric Exclusivity Applies Applications containing the active moiety held by the same sponsor Unapproved applications upon approval Later-filed NDAs & Supplements data earned prior ped. ex and essential to approval of later-filed NDA or supp. Moieties in Multiple Products : Moieties in Multiple Products Monotherapy montherapy exclusivities monotherapy patents Combination Therapy combination protections each montherapy’s protections How does a sponsor qualify for pediatric exclusivity? : How does a sponsor qualify for pediatric exclusivity? FDA issues an official Written Request for pediatric studies Sponsor conducts studies in accordance with a Written Agreement or commonly accepted scientific principles Sponsor files reports of studies that meet the terms of the Written Request Written Requests : Written Requests FDA assesses what studies on the moiety are needed to produce a health benefit in the pediatric population. Recommend sponsors provide a proposed pediatric study request as a first step. Written Request may or may not reflect some or all elements in the sponsor’s proposal. FDA can issue a Written Request without a sponsor’s request. Can you earn more than one 6-month period of pediatric exclusivity? : Can you earn more than one 6-month period of pediatric exclusivity? Response to the Written Request is a supplement for a new use. A new use is a use that is not included in the approved labeling of an approved drug, including a new pediatric population. The supplement qualifies for 3-year Waxman-Hatch exclusivity The 6-month period of pediatric exclusivity attaches only to the 3-year exclusivity. Sunset : Sunset FDA can issue a Written Request for a drug (active moiety) after January 1, 2002, only if: an application for the drug is submitted on or before January 1, 2002; and the drug was in commercial distribution on November 21, 1997; and the drug is on the List on January 1, 2002; and FDA finds that there is continuing need for information and the drug may provide health benefits Sunset : Sunset Studies submitted on or after January 1, 2002, can earn pediatric exclusivity if: the studies are submitted in response to a Written Request issued on or before January 1, 2002, and the Written Request is for a drug (active moiety) for which an application was submitted on or before January 1, 2002. FDA cannot issue a Written Request for a drug (active moiety) after January 1, 2002, if the first application for the drug is submitted after January 1, 2002. Report to Congress : Report to Congress Due January 1, 2001 Must address: effectiveness in obtaining pediatric information adequacy of incentive economic impact suggestions for modification Actions as of 12/1/99 : Actions as of 12/1/99 119 Written Requests 39 Incomplete Responses 1 PPSR Withdrawal 44 Amended Written Requests PPSRs RECEIVED = 184 TOTAL ACTIONS = 203 PPSRs PENDING = 36 PPSRs > 4 months = 14 Pediatric Exclusivity Determinations as of 12/1/99 : Pediatric Exclusivity Determinations as of 12/1/99 Granted on Approved Moieties: 9 Granted on Unapproved Moieties: 3 Pending Review: 2 Denials: 2 Pediatric Exclusivity Summary : Pediatric Exclusivity Summary Extends 3/5/7 year exclusivity by 6 months Grants 6 months exclusivity after expiration of a submitted patent Approval not necessary - ped. ex. determined within 60/90 days after filing of responsive reports of studies Sunset January 1, 2002 Resources on Pediatric Exclusivity : Resources on Pediatric Exclusivity The Statute: 21 U.S.C. 505a Guidance for Industry: Qualifying for Pediatric Exclusivity, including Frequently Asked Questions www.fda.gov/cder/pediatric PEDS Line: 301-594-PEDS (7337) EMail: pdit@cder.fda.gov Pediatric Advisory Subcommittee How do 505(b)(2) applications fit into the world of exclusivity? : How do 505(b)(2) applications fit into the world of exclusivity? Like ANDAs Blocked by exclusivity Required to file patent certifications Unlike ANDAs Able to earn exclusivity May differ from RLD in more ways than those permitted by suitability petition process What is a 505(b)(2) application? : What is a 505(b)(2) application? A new drug application containing One or more investigations necessary to approval that were not conducted by applicant and for which applicant has no right of reference What information can an applicant rely on? : What information can an applicant rely on? Published literature specific to the approval sought in the NDA FDA’s finding of safety and effectiveness for an RLD Examples of 505(b)(2) applications : Examples of 505(b)(2) applications Dosage form Strength Route of administration Substituted active ingredient in combo. Formulation Dosing regimen Active ingredient Intentional bioinequivalence Combo. of individually approved products Indication Rx/OTC Switch OTC monograph Naturally derived or recombinant active ingredient NME Resources on 505(b)(2) applications : Resources on 505(b)(2) applications 21 USC 355(b)(2) 21 CFR 314.50 - NDAs 21 CFR 314.54 - 505(b)(2) applications 21 CFR 314.108 - Exclusivity DRAFT Guidance for Industry: Applications Covered by Section 505(b)(2) Exclusivity & Patent Listings : Exclusivity & Patent Listings Published in the Orange Book Available in hard copy and at www.fda.gov/cder/ob/default.htm Lists all current exclusivities and submitted patents Where can I get more information? : Where can I get more information? Leanne Cusumano, 301-594-2041 GC (Kim Dettelbach), 301-827-1148 OGD Pediatric Implementation Team 301-594-PEDS Terrie Crescenzi, PM

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