FDA Approves 100th Competitive Generic Therapy Drug, Marking Success of Program Encouraging Development and Marketing of Products with Inadequate Generic Competition The U.S. Food and Drug Administration is pleased to report we have now approved more than 100 abbreviated new drug applications (ANDAs) for generic drugs with a Competitive Generic Therapy (CGT) designation. The CGT designation pathway, established in 2017, was designed to encourage the development of drug products with little to no generic competition. Under authorities provided to the agency in the FDA Reauthorization Act of 2017 (FDARA), a drug can be designated as a Competitive Generic Therapy if there is inadequate generic competition for that drug, meaning there is not more than one approved drug in the active section of the Orange Book. At the request of the applicant, FDA may take steps to expedite the development and review of ANDAs for drugs that receive a CGT designation. Applicants for drugs that receive a CGT designation may also be eligible for a 180-day period of marketing exclusivity if they are the first approved applicant for that CGT and meet certain other conditions. Under a special forfeiture rule for CGTs, the applicant must commercially market the CGT within 75 calendar days after the date of approval of its ANDA or it will forfeit its exclusivity. Since Congress provided us with this authority, we have received almost 700 requests for CGT designation from drug manufacturers. As of August 30, FDA has approved 101 ANDAs with a CGT designation, with more than half (56) receiving exclusivity. Nearly 75% (41) of those have already taken advantage of that exclusivity by marketing within the 75-day window after approval, thereby enhancing consumer access to these products. Our CGT approvals have covered a broad range of products and therapeutic areas, and include treatments for: - emergency reversal of opioid overdose (public health emergency approvals)
- eye pain and inflammation (the first gel ANDA approved for ophthalmic administration)
- hereditary tyrosinemia (orphan indication)
The CGT program is part of our Drug Competition Action Plan, which seeks to foster generic competition and help address the high cost of drugs. This pathway is a key step in making safe and effective generic drugs available to patients quickly and ensuring there is adequate competition so patients have more affordable access to the treatments they need. Additional Resources - Competitive Generic Therapy Approvals – web page listing all approved ANDAs for products that received a CGT designation. The list is updated on a bi-weekly basis and includes information about the approved application, drug product and any potential CGT exclusivity.
- Competitive Generic Therapies – guidance for industry providing a description of the process that applicants should follow to request designation of a drug as a CGT, the criteria for designating a drug as a CGT, and information on CGT exclusivity.
- Drug Competition Action Plan – web page outlining FDA's efforts to further encourage robust and timely market competition for generic drugs and help bring greater efficiency and transparency to the generic drug review process, without sacrificing the scientific rigor underlying our generic drug program.
- FDARA Sections 805 and 807 Activities Report – quarterly reports that include information on the number of ANDAs for CGT-designated drugs awaiting FDA action or applicant action, the number approved, and more.
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