Undaunted Ranbaxy targets generic exclusivity in U.S.

Ranbaxy Laboratories has been through a boatload of turmoil this year, but the CEO of India's largest generic drugmaker comes off as unfazed. In fact, he is touting big plans in the U.S. for the company.

Arun Sawhney told Reuters today that the company intends to file three or four generic drug applications every year aimed to capture 180-day exclusivity in the U.S. Under U.S. law, the first to file for a generic drug is granted the 6-month lock on sales as an incentive to get cheaper drugs to the market faster. "We have a very ambitious growth plan for our U.S. business," he said.

This pledge comes just a month after the Indian company paid $500 million and pled guilty to 7 felonies, settling the long-running troubles it ran into with U.S. authorities for manufacturing substandard drugs and then trying to cover up the problems. As part of its agreement with the U.S., the drugmaker has had to forfeit the exclusivity on three undisclosed drugs that it had hoped to tap for big sales.

The company has not said which drugs it agreed to give up.  Analysts last year pointed to the fact that it did not put out a version of Provigil, a drug Teva Pharmaceutical Industries ($TEVA) picked up with its acquisition of Cephalon. Ranbaxy had previously gained exclusive rights to Provigil. Analysts had predicted the company could have earned $200 million on that one drug during the exclusive period. There was also speculation that Ranbaxy might have forfeited exclusivity to Novartis' ($NVS) Diovan, because the FDA has not approved its version even though the patent went off in September. But Ranbaxy has said, while delayed, its right remains on that drug.

Sawhney did not say which drugs his company would target first but did give a clue where it was looking. "We are targeting three to four first-to-file filings every year ... We will be strengthening our dermatology business in the U.S. with a good slew of products in the future," he told Reuters.

- here's the Reuters story