Sunday, August 20, 2006

Authorized generic dimension coming into play in PLAVIX saga?

Dr. Reddy's Laboratories [DRL] has already filed an ANDA [abbreviated new drug application] for Plavix with the US FDA in 2002. Also, BMS has admitted that it had engaged DRL in talks to settle the deal. Because DRL is an experienced player in the authorized generic area, DRL is a most suitable contender to the role to provide product for a PLAVIX authorized generic.

DRL is also collaborating with innovator Merck to bring out an authorized generic of cholestrol drug Zocor, on which Ranbaxy and Teva have secured 180-day exclusivity rights for their copycat versions [different strengths for Ranbaxy and Teva, with Teva having the preferred strength]. Generic versions of Zocor may undercut sales of Pfizer's Lipitor.

However, will an authorized generic really impact the situation?

From Marketplace:

Morningstar analyst Tom d'Amore says Apotex managed to ship out enough generic product to last pharmacists for months. The hearing on Friday, Aug. 18 in which BMS sought an injunction to stop Apotex shipping its generic, and to recall any product already in pharmacies. But it may be too late, says Nielsen Hobbs of the pharmaceutical letter The Pink Sheet.

D'Amore is also quoted: The management of Apotex has out-maneuvered Bristol Myers, both in terms of the negotiations and now in terms of their operations.


Of course, it may be that the patent position of BMS was exceptionally weak in this enantiomer/racemate case.



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