180-Day Exclusivity for Generics: FDA Releases Draft Guidance

Regulatory NewsRegulatory News | 12 January 2017 |  By 

The US Food and Drug Administration (FDA) on Thursday put out new draft guidance consisting of 45 questions and answers on the 180 days of exclusivity provided to some generic drugs.


The statute provides an incentive and a reward to generic drug applicants that expose themselves to the risk of patent litigation. It does so by granting a 180-day period of exclusivity for an abbreviated new drug application (ANDA)  applicant that is first to file a substantially complete ANDA containing a paragraph IV certification to a listed patent.

If an ANDA meets the requirements for approval but cannot be finally approved due to unexpired patents or exclusivities, FDA will tentatively approve the ANDA.

There are a number of conditions under which an ANDA applicant may forfeit eligibility for 180-day exclusivity (all which are further explained in the draft), including: (1) failure to market the drug; (2) withdrawal of application; (3) amendment of certification; (4) failure to obtain tentative approval; (5) entry into agreement with another applicant, the listed drug application holder, or a patent owner; and (6) expiration of all patents.


The draft guidance discusses 180-day exclusivity as it pertains to ANDAs subject to the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) statutory provisions, offering an explanation for how the agency determines whether the pre-MMA or MMA provisions of the Food Drugs & Cosmetics Act (FD&C Act) apply to a particular ANDA.

The guidance also explains how an ANDA applicant can qualify as a first applicant, what constitutes a “substantially complete application,” whether an ANDA applicant can qualify as a first applicant when it includes both a paragraph IV certification and a section viii statement to a single listed patent (it can), whether an authorized generic can be marketed during the 180-day exclusivity period (it can), and how the timing of sending notice of paragraph IV certification can affect first applicant status.

“For original ANDAs, notice of paragraph IV certification must be provided on or after the date on which the applicant receives a paragraph IV acknowledgment letter from FDA, but not later than 20 days after the date of the postmark on the paragraph IV acknowledgment letter,” FDA says.

The agency also notes that there can be different first applicants for different strengths of a drug and how an ANDA applicant can potentially retain eligibility for 180-day exclusivity even if it is not sued over its ANDA, or if sued, the case is resolved or settled.

“The 180-day exclusivity provisions were drafted to give ANDA applicants an incentive to be the first to challenge a listed patent, potentially removing that patent as a barrier to approval. Once a listed patent expires and is no longer a barrier to ANDA approval, there is no longer a need to provide an incentive to challenge it in court. Thus, an expired patent does not serve as the basis for a

180-day exclusivity award, and 180-day exclusivity does not extend beyond the life of the patent,” the draft says. FDA also said it intends to update this guidance to include additional questions and answers as appropriate.

Draft Guidance for Industry 180-Day Exclusivity: Questions and Answers


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy