Report: Teva, Ranbaxy team up to launch U.S. Lipitor copy

Teva Pharmaceutical Industries is hinting at a big windfall from a soon-to-be launched new product. Ranbaxy Laboratories has exclusive rights to sell copycat Lipitor as of Nov. 30, but may not have the manufacturing wherewithal to make it happen. Add one and one together, and you get a Teva-made atorvastatin, sold in the U.S. in partnership with Ranbaxy.

"What other product can give Teva 10 cents of earnings per share or $89 million net income in one month?" Sanford C. Bernstein analysts wrote in a report to investors (as quoted by Bloomberg). Indeed, this "important undisclosed product" launch would make the difference in Teva's ability to hit the top end of its annual earnings forecast.

The Teva-Ranbaxy collaboration was originally reported by Calcalist, and picked up by the Israeli news site Ynet. The gist is that Teva's version of Lipitor--which it launched briefly in the U.K. this year--will hit the U.S. market via a partnership with Ranbaxy. A deal with Teva would help explain why Ranbaxy officials have been so adamant that they'll launch a version of Lipitor as soon as their patent settlement with Pfizer allows.

The Indian drugmaker, recall, has been struggling to win FDA clearance for manufacturing facilities that failed inspections in 2009. About 30 Ranbaxy products have been under an import alert ever since. Because the company was first to file for FDA approval, it has 180-day exclusivity on a Lipitor generic, and with Ranbaxy's ability to perform in question, rival generics maker Mylan sued the FDA for the right to step in. That effort failed, but the questions remained, even as Ranbaxy execs promised they were working something out.

Ynet says Ranbaxy would prefer to launch atorvastatin on its own, but that teaming up with Teva will allow it to maximize its earnings on sales of the drug. It's unclear at this point how the partnership would be structured--or whether it's a real deal at all. Stay tuned.

- get the Ynet News story
- see the Bloomberg piece
- read the coverage from the Business Standard
- check out the Bloomberg brief