Teva Pharmaceutical Industries has won the right to sell a copycat version of Bristol-Myers Squibb’s cholesterol-lowering drug, Pravachol (pravastatin sodium), in the USA with six months’ exclusivity.
Teva, set to become the biggest generic drugmaker in the world following its merger with Ivax [[12/10/05e]], was granted the exclusivity period for 10mg, 20mg and 40mg pravastatin tablets by a US federal judge under the Hatch-Waxman legislation that rewards generics companies who file first for approval of a generic.
The ruling gives Teva first stab at winning a slice of B-MS’ $1.6 billion dollars in annual US sales for Pravachol, which loses patent protection in April 2006. However, other generics companies that have filed for approval of generic pravastatin - notably Ranbaxy Laboratories and Apotex - are expected to try to overturn Teva’s exclusivity in the courts.
Teva sued the US Food and Drug Administration after it ruled this summer that the Israeli company was not entitled to six months’ exclusivity for generic Pravachol because an earlier lawsuit between B-MS and Apotex, which was dismissed on August 22 last year, initiated Hatch-Waxman from that date [[07/07/05c]].
The ruling rounded off a good week for Teva. Earlier, the company had been named as one of four companies that stand to benefit from Roche relaxing its proprietary position on the pandemic flu drug Tamiflu (oseltamivir) [[21/10/05a]], while it also benefited from a settlement in a patent infringement lawsuit with Wyeth [[19/10/05e]].