FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Addresses Murky Aspects of 180-Day Exclusivity for Generics in Draft Q&A Guidance

Jan. 20, 2017

The FDA responded to commonly raised questions about the 180-day exclusivity for generics in a draft guidance document covering everything from patents to forfeitures.

The 27-page Q&A guidance is divided into seven sections, with each dedicated to a distinct aspect of the 180-day exclusivity, including applicable statutory schemes, first applicants, relinquishment, waivers and procedural questions.

An applicant forfeits exclusivity when: the generic is not marketed; an ANDA is withdrawn; a paragraph VI certification is amended; the sponsor fails to obtain a tentative approval; the generic maker enters an agreement with a competitor or the patent holder; and the patents covering the reference drug expire.

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