While the world has been watching the tussle over Ranbaxy Laboratories' generic version of Lipitor--which may or may not be FDA-approved by the time the mammoth cholesterol drug comes off patent--the Indian drugmaker has been struggling to live up to another supply target.
The drug in question is Nexium, the blockbuster stomach-acid remedy from AstraZeneca. After a hard-fought patent dispute, Ranbaxy agreed to hold off on its generic version until May 2014, while AstraZeneca agreed to farm out some production of Nexium and its active ingredient to the Indian firm beginning in May 2010.
However, Ranbaxy wasn't ready to start supplying AstraZeneca in May of last year. Just as in the case of Lipitor, Ranbaxy lacks FDA approval for its version of Nexium. The drugmaker has been on the rocks with the FDA for more than a year. Manufacturing snafus prompted an import ban on 30 Ranbaxy products, and the FDA has had Ranbaxy under its thumb ever since. The company has been negotiating terms with the agency, but no agreement has emerged as of yet.
Ranbaxy now says it expects to start delivering on the supply deal toward the end of this year. Coincidentally, Lipitor's patent expires toward the end of this year, too. Whether Ranbaxy will actually have its FDA troubles all sorted by then is anybody's guess.
- read the Economic Times story