Upsher-Smith’s Namenda ANDA Wins FDA Approval

Upsher-Smith Laboratories has launched its generic version of Actavis’ Alzheimer’s drug Namenda immediate release in the U.S. market, following FDA approval of an ANDA, the company said Aug. 10.

Memantine hydrochloride, available in 5 mg and 10 mg strength tablets, is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.

In July, Mylan and Dr. Reddy’s Laboratories each launched generic versions the drug. The two companies share 180-day generic drug marketing exclusivity for Namenda IR as first filers of an ANDA with a paragraph IV certification. A total of nine other generic versions may enter the market as early as October.

In May, the Second Circuit Court of Appeals upheld a lower court’s preliminary injunction requiring Actavis and partner Forest Laboratories to make Namenda IR available until Aug. 11 nationwide (Generic Line, June 10). The company had sought to pull Namenda IR and replace it with the newer Namenda XR to block generic competition.

Namenda had U.S. sales of about $1.4 billion for the 12 months ending in May, according to IMS Health. — Jonathon Shacat



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