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news.Actavis has filed an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) for marketing the generic versions of Oleptro (trazodone hydrochloride extended-release 150 and 300mg tablets) in the US.
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Oleptro extended release tablets are once-daily formulation of the antidepressant trazodone, for the treatment of major depressive disorder (MDD) in adults.
Under the Drug Price Competition and Patent Term Restoration Act (known as the Hatch-Waxman Act), Oleptro has a new dosage form market exclusivity period that prevents final approval of Actavis’ ANDA until the exclusivity period expires on 2 February 2013.
Activis’ ANDA consists of a paragraph IV patent certification to obtain approval to manufacture, use, or sell its generic versions before the expiration of patent # 6,607,748, which is owned by Labopharm, in June 2020.