Mylan, Dr. Reddy’s Release Generic Namenda
Mylan and Dr. Reddy’s Laboratories this week each launched generic versions of Actavis’ Alzheimer’s drug Namenda.
The companies share 180-day generic drug marketing exclusivity for Namenda IR (memantine hydrochloride) as first filers of an ANDA with a paragraph IV certification. A total of 10 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 its Namenda IR available until Aug. 11 nationwide.
Namenda had U.S. sales of about $1.4 billion for the 12 months ending in May, according to IMS Health. — Jonathon Shacat