Competitive Generic Therapies | FDA

Competitive Generic Therapies | FDA

Featuring LCDR Rinku Patel, Pharm.D., Patent & Exclusivity Team, Office of Generic Drugs Policy

Drug development can be more challenging for products with limited markets, complex formulations or modes of delivery. This may translate into single source drugs with no generic competition for products with these characteristics. FDA recognizes this and has taken steps to incentivize generic competition for drugs with these challenges to help ensure patients have more access to affordable and high-quality generic drugs. One important part of these efforts is the new Competitive Generic Therapies (CGT) pathway, which is intended to stimulate generic drug development where inadequate generic competition exists.

The CGT pathway is a key component of FDA’s Drug Competition Action Plan, which aims to encourage robust and timely market competition for generic drugs so that patients can get access to the safe and effective medicines they need at affordable prices.  Created under the FDA Reauthorization Act of 2017 (FDARA), the CGT pathway established a process through which FDA may, at the request of an applicant, designate a drug with “inadequate drug competition” as a CGT and may also expedite the development and review of the abbreviated new drug application (ANDA) for that drug. The pathway also includes a new type of 180-day exclusivity for the first approved applicant of a drug with a CGT designation for which there were no unexpired patents or exclusivities listed in the Orange Book at the time of the original submission of the ANDA. FDA recently issued a draft guidance on CGTs to provide generic drug applicants with information on how to request a CGT designation and whether they may be eligible for CGT exclusivity.

The success of the program to date is in the numbers. As of March 2019, the FDA has received more than 245 CGT requests, of which over 70% have been granted. FDA has also approved seven ANDAs for generic drugs designated as CGTs that qualified for 180-day CGT exclusivity. FDA’s quarterly CGT application reports provide transparency on the numbers of ANDAs with a CGT designation.

Designation of a drug as a CGT. The applicant may request that a drug be designated as a CGT concurrently with, or any time prior to, the original ANDA submission.  FDA must then determine that there is “inadequate generic competition” for the drug for it to be designated as a CGT.  To qualify, there cannot be more than one approved drug in the active section of the Orange Book at the time FDA makes its determination. This may include the reference listed drug (RLD) or a generic drug that references the same RLD as the drug for which designation as a CGT is sought. FDA intends to make a determination within 60 calendar days of receipt of the request.

In the cover letter accompanying the request for designation, the applicant should include a pre-assigned ANDA number, a statement supporting the request for designation (details in the guidance), and information supporting the claim that there is inadequate generic competition for the drug