Generic floodgates open for Plavix in U.S.

Plavix is a blood thinner from Bristol-Myers Squibb ($BMY). Generic Plavix is a Bristol-Myers profits thinner that is going to be produced by just about everybody and their brother.

The FDA on Thursday approved a long list of companies that supply clopidogrel, the generic version of the megablockbuster drug that last year brought in about $6.8 billion in the U.S. for BMS and its partner Sanofi ($SNY).

In an effort to hold onto as much of that revenue as they can, the pair said they will be offering current patients a special program that would bring the monthly cost of Plavix down to $37 from the expected $100, reports The Wall Street Journal. It is a tactic used to little success by Pfizer ($PFE) in the face of the generic onslaught on Lipitor. Lipitor last year was the only drug that outsold Plavix in the U.S., but it has seen such erosion of market share that Pfizer has quietly given up marketing it.

BMS executives acknowledge that in a generic Plavix world, sales gains are going to be more difficult to cultivate. Plavix last year accounted for 33% of its revenue. They were encouraged by growing sales of some new drugs in the first quarter, including cancer drug Yervoy, hepatitis B drug Baraclude, and Sprycel, a drug for chronic myeloid leukemia, which posted a 34% gain to $231 million.

So who gets to sell generic Plavix in the U.S.? The 75-milligram dose will be sold by Mylan Pharmaceuticals ($MYL), Teva Pharmaceutical Industries ($TEVA),  Apotex, Aurobindo Pharma, Roxane Laboratories, Sun Pharmaceutical Industries and Torrent Pharmaceuticals, the WSJ says.

Teva, Mylan, Dr. Reddy's Laboratories and Gate Pharmaceuticals, get to sell a 300-milligram dose of clopidogrel, with Mylan getting an 180-day exclusivity for being first across the approval finish line. Mylan apparently has its clopidogrel ducks all lined up because it says it is shipping its products immediately. 

- here's the WSJ story
- read the FDA release