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Lupin Sued by Bausch + Lomb and Senju Over Generic Prolensa

July 8, 2014

Indian generics maker Lupin Pharmaceuticals is being sued by Valeant Pharmaceuticals subsidiary Bausch + Lomb and Senju Pharmaceuticals over its ANDA for Prolensa eye drops.

Japan-based Senju owns the patent on Prolensa (bromfenac sodium) and Bausch + Lomb holds the drug’s NDA in the U.S. The companies argue in their June 26 complaint that Lupin’s Prolensa generic would infringe the drug’s ‘290 patent, which doesn’t expire until 2024, according to the Orange Book.

Bausch + Lomb received notice of the ANDA on May 13, the complaint says. The NDA was approved in April 2013, and the patent was issued in March of this year.

Prolensa is indicated as a treatment for inflammation and pain in patients who have just had cataract surgery.

Lupin did not respond to a request for comment by press time. — Bryan Koenig

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.