TEVA GENERIC FOCALIN APPROVAL EMBROILED IN PATENT LITIGATION

Despite being the first to win final FDA approval -- with 180 days of exclusivity -- to manufacture and market generic Focalin, Teva Pharmaceutical still has to prevail in court against Novartis and Celgene.

The two companies filed their complaint last month in the U.S. District Court for the District of New Jersey in an effort to block sales of generic Focalin, a drug used to treat attention-deficit/hyperactivity disorder (ADHD). In a written response to the new complaint, Teva said its generic product does not infringe on the brand product's patent because the patent is invalid and unenforceable.

Attorneys for Teva did not return calls seeking comment and it remains unclear how soon the company will enter the market with its generic product.

"It is uncertain whether Teva would attempt to launch a generic Focalin while engaged in the patent lawsuits with Celgene and Novartis, potentially risking a finding of willfull infringement," said Merrill Lynch research analyst Thomas McGahren in a Jan. 29 research note.

Novartis has an exclusive license agreement with Celgene related to the three patents it owns covering Focalin. They expire Dec. 4, 2015.