Watson seeks FDA approval for depression generic
MORRISTOWN, N.J. Watson Pharmaceuticals has filed a regulatory approval application with the Food and Drug Administration for a generic drug to treat depression, the generic drug maker announced Monday.
Watson filed an application for bupropion hydrobromide tablets in the 174-mg and 348-mg strengths through its subsidiary, Watson Labs Inc.-Florida. The drug is a generic version of Biovail’s Aplenzin ER, used to treat major depressive disorder.
Because Watson filed its application prior to the expiration of Biovail’s patents, Biovail filed suit against Watson Thursday in the U.S. District Court for the District of Delaware. Under the Hatch-Waxman Act of 1984, the suit places a stay of final FDA approval on Watson’s version of the drug for up to 30 months or until the two companies resolve the matter before the court.
Watson said it may be the first company to file for approval of a generic version of Aplenzin, which would allow it to compete directly with the branded version of the drug for six months following patent expiration, which will occur in 2026, according to FDA records.