Competitive Generic Therapy – 180 Days Exclusivity – Are you ready?

This new approval pathway was created to expedite the development and review of a generic drug for products that lack competition.

Under new authorities provided to the agency in the FDA Reauthorization Act of 2017 (FDARA), a drug can be designated as a Competitive Generic Therapy (CGT) 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.

Applicants for drugs that receive a CGT designation may receive review enhancements and expedited review of their Abbreviated New Drug Applications (ANDA). Applicants for drugs that receive a CGT designation are also 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 days after the date of approval of its ANDA or it will forfeit its exclusivity.

Earlier this month, Apotex received approval for potassium chloride oral solution USP with CGT exclusivity.

On Aug 22, 2018, Strides Pharma Science Limited announced that its subsidiary received two key ANDAs acceptance with CGT designation from USFDA. As per IQVIA MAT data, the US market for these products cumulatively is US$ 550 Mn.

There are multiple such products that will be into CGT designation. This new FDA program can emerge as new business model for generics with 180 day exclusivity.

For more details:

Leave a comment