Teva Launches Its Generic Baraclude

Israeli firm Teva has launched the first generic version of Bristol-Myers Squibb’s hepatitis B drug Baraclude in both its 0.5 mg and 1 mg tablet strengths.

Teva was the first generics maker to challenge Baraclude’s (entecavir) ’244 patent with a Paragraph IV ANDA filed in 2010, making it eligible for 180 days of market exclusivity under Hatch-Waxman, the company said. The patent was set to expire in February 2015, according to the Orange Book.

Teva had already won tentative FDA approval for a generic launch when a federal appeals court in June upheld a lower court ruling invalidating Baraclude’s patent. The court found at the time that the drug’s main ingredient would have been an obvious one for other drugmakers to try when the therapy was first developed in the late 1980s.

Baraclude generated $328 million in annual U.S. sales as of June 2014 according to IMS data, Teva said. — 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.