Watson Pharmaceuticals has started shipping a generic version of Bristol-Myers Squibb’s cholesterol-lowerer Pravachol in the USA under a distribution agreement with Bristol-Myers Squibb.
The launch of the ‘authorised generic’ comes immediately after Teva Pharmaceutical Industries entered the market for generic Pravachol (pravastatin) in the USA with 180 days’ marketing exclusivity under the country’s Hatch-Waxman legislation, which is designed to encourage the development of generics by offering the first company to file for approval of a copycat version six months’ grace before other generics can be launched.
The US Federal Trade Comission (FTC) is currently investigating this type of authorized generic agreement to establish whether they constitute anticompetitive practice, and last month said it planned to subpoena 190 drugmakers as part of the probe.
Like Teva, Watson has launched 10mg, 20mg and 40mg strengths of pravastatin, which together accounted for sales of $1.5 billion in 2005. B-MS’ patent on the drug expired on April 20.