Generic Reyataz Bid Prompts BMS Suit

Bristol-Myers Squibb is suing to block Mylan’s Paragraph IV ANDA against the brandmaker’s blockbuster HIV therapy Reyataz.

The Hatch-Waxman patent infringement lawsuit accuses Mylan of infringing the ‘383 patent protecting Reyataz (atazanavir). The patent doesn’t expire until 2018, according to the Orange Book.

Mylan’s ANDA targets Reyataz in its 150, 200 and 300 mg capsule versions, according to the complaint filed March 19 in the U.S. District Court for the Northern District of West Virginia. BMS received word of the ANDA filing in a Feb. 3 notice, the brandmaker says in Bristol-Myers Squibb v. Mylan.

Should Mylan successfully strike down Reyataz’s patent, fellow generics maker Teva may be able to launch early based on a patent infringement settlement it signed with BMS and Reyataz licenser Novartis in 2011. That agreement allowed for generic entry by 2017.

BMS reported $1.3 billion in total sales last year from Reyataz.

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