USP, FDA Work to Promote Generics Development for Off-Patent Meds

The United States Pharmacopeia (USP) and the FDA are working together to promote opportunities for sponsors to develop new generic medications for off-patent drugs that currently lack an approved generic equivalent.

The FDA’s newly updated list of off-patent, off-exclusivity drugs lacking an approved generic (OPOE) comprises 383 prescription medications and one non-prescription medication, opening a potential opportunity for drug manufacturers to submit an ANDA referencing those products. The agency hopes to spark interest in this underserved area of generics competition.

“To date, USP has developed 19 monographs associated with 18 drug products on the OPOE list,” the FDA said. Most recently, the USP proposed a new monograph for triptorelin pamoate, manufactured by Azurity Pharmaceuticals under the brand name Triptodur. The gonadotropin-releasing hormone (GnRH) agonist reduces testosterone production and is used to treat prostate cancer. The monograph is currently open for public comment through July 31.

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