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FDA marks competitive generic therapy approval milestone

The agency has approved more than 100 generic drugs with the competitive generic therapy designation since it launched the effort in 2017.

The Food and Drug Administration is marking progress in its efforts to bring more generics to market for products that have little or no generics available. The agency this past week noted that it has approved more than 100 medications under its competitive generic therapy designation. 

“There has been incredible interest in the competitive generic therapy program since its inception in 2017,” said Sally Choe, director of the Office of Generic Drugs at the FDA’s Center for Drug Evaluation and Research. “Hundreds of applicants have requested competitive generic therapy designations, providing the ability for the FDA to approve more than 100 of these applications in less than four years, among a broad range of products and therapeutic areas.

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The agency issued its first competitive generic therapy designation in August 2018 and it finalized the guidance for the industry on the topic in March 2020, formally outlining the process that generic drug makers should follow to request the designation. At the applicant’s request, the FDA can expedite the development and review of applications for drugs that receive the competitive generic therapy designation. 

Companies that receive the competitive generic therapy designation may be eligible for a 180-day exclusivity period if they are the first approved applicant for the drug and meet certain other conditions. Additionally, the company must market the drug within 75 calendar days of it being approved by the FDA to take advantage of the exclusivity. 

“More than 80% of the first-approved applicants who were eligible for competitive generic therapy exclusivity started marketing the drug within 75 days after FDA approval,” Choe said. “This is a sign the program is achieving what we hoped — spurring both development and market availability of safe and effective generic drugs in areas of the market that previously had little to no competition, giving patients more affordable access to medicine.”

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