D1S15-Strandberg-v1.2-FINAL.pdf

1、Addressing Patent and Exclusivity Requirements-Regulatory RemindersHeather Strandberg,PharmDPatent and Exclusivity TeamDivision of Legal and Regulatory Support(DLRS),Office of Generic Drug Policy(OGDP),Office of Generic Drugs(OGD)CDER|US FDASBIA Generic Drug Forum April 22-23,2026www.fda.gov2Overvie

2、wReview regulatory requirements related to the most common patent and exclusivity deficiencies,including:Addressing later-listed patents/patent information and new exclusivities Adequate documentation of notice of paragraph IV certification Notification of the filing of legal action,court orders and

3、 licensing agreements Pediatric ExclusivityDiscuss timely notification of commercial marketingReview the Agencys Paragraph IV Certifications List and Competitive Generic Therapy Approvals Listwww.fda.gov3Addressing Later-Listed Patents and Patent Information21 CFR 314.94(a)(12)(vi)(A)Address all new

4、,timely filed,later-listed patents and patent information(e.g.,use codes)with a patent certification or section viii statement,as applicableNew or updated,timely filed patent listings require new certifications or statements Prior Paragraph IV(PIV)certification for the same patent does not sufficien

5、tly address newly listed patent information(e.g.,new or revised use codes)www.fda.gov4Applicants that elect to submit a PIV certification to a timely filed,later-listed patent or use code must comply with the notice requirements under 21 CFR 314.95 Includes providing adequate documentation of notice

6、(21 CFR 314.95(e)Prior notice sent for PIV certification to the same patent is not sufficient notice for PIV certification to new patent information(e.g.,new use code)Notice Requirements for PIV Certifications Submitted After Original Submission of ANDAwww.fda.gov5Update exclusivity statement provid