On March 13, 2020, FDA issued final guidance on Competitive Generic Therapies. The FDA Reauthorization Act of 2017 (FDARA) created a new pathway to designate, and expedite the development and review of, certain drugs with “inadequate generic competition” as competitive generic therapies (CGTs). In this guidance, FDA describes the process and criteria for designating a drug as a CGT, methods to expedite development and review of CGT ANDAs, and provisions for a new 180-day exclusivity period for first approved CGTs.

FDA may designate a drug as a CGT after determining that there is inadequate generic competition for that drug, which FDA defines as having not more than one approved drug included in the active section of the Orange Book for either the reference listed drug (RLD) or approved generic drug referencing the same RLD. In evaluating whether there is not more than one approved drug, FDA considers whether the product(s) in the active section is the same strength(s) as the product for which CGT designation is being sought.  

As the guidance explains, requests to designate a drug as a CGT (Requests for Designation) can be submitted prior to or concurrently with an original ANDA submission. The Requests for Designation should include sufficient identification of the reference listed drug that is the basis of the submission and information supporting the applicant’s assertion that there is inadequate generic competition.  Requests for Designation submitted after the submission of the original ANDA are untimely and will not be considered, except where a refuse-to-receive (RTR) determination has been made. FDA intends to make a determination on a Request for Determination within 60 days of the request. Once a product in an applicant’s ANDA gets CGT designation, that designation remains even if there is no longer inadequate generic competition prior to approval of that application. 

For drugs designated as CGTs, applicants may request expedited development and review of their ANDA applications. To expedite development, FDA considers, among other factors, the complexity of developing an application for the specific drug subject to the request, the potential public health impact, and the impact on FDA resources and workload commitments. Applicants can request to meet with FDA to discuss specific scientific or regulatory questions related to an ongoing development program or to discuss the content and format of an ANDA submission. FDA will generally not expedite the review of ANDAs covering CGTs if, at the time of ANDA submission, there are unexpired patents or exclusivities listed in the Orange Book. 

Additionally, a CGT designation does not ensure a shorter GDUFA goal date. FDA may employ various methods to expedite review including mid-review-cycle teleconferences and coordinated, cross-disciplinary review by experienced health project management staff (e.g., expertise in bioequivalence, quality, or labeling). FDA will also review ANDAs for drugs designated as CGTs consistent with MAPP 5241.3 Good ANDA Assessment Practices, which established good assessment practice with the goal of decreasing the number of review cycles to approve ANDAs that met the requirement for approval.

This guidance also explains a new type of 180-day exclusivity for the first approved applicant that (1) obtains approval for a drug that has been designated as a CGT and for which there are no unexpired patents or exclusivities listed in the Orange Book, and (2) commercially markets such drug within 75 calendar days after ANDA approval. FDA clarifies that this new CGT exclusivity is different than the 180-day patent challenge exclusivity under section 505(j)(5)(B)(iv). A first-approved CGT applicant will not receive CGT exclusivity if it is eligible for 180-day patent challenge exclusivity for the same drug designated as CGT. Additionally, the potential first approved applicant’s ANDA cannot be for a drug for which other ANDA applicants were eligible for 180-day patent challenge exclusivity under section 505(j)(5)(B)(iv) of the FD&C Act and all such ANDA applicants have forfeited eligibility for such 180-day patent challenge exclusivity. FDA intends to permit a first approved applicant to relinquish and/or grant selective waiver of CGT exclusivity, similar to FDA’s longstanding practice of permitting relinquishment and selective waiver of 180-day patent challenge exclusivity.

Readers are encouraged to read the final guidance, also available on FDA’s website.

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