FDAnews Drug Daily Bulletin


April 14, 2006

In a reversal of an earlier decision, the FDA said the 180-day marketing exclusivity period has not been triggered for the Bristol-Myers Squibb (BMS) cholesterol drug Pravachol, Teva Pharmaceutical said recently. Teva expects to receive final approval with exclusivity on April 20, when the drug patent expires.

The FDA informed Teva in July 2005 that its anticipated 180-day exclusivity period for pravastatin in 10-, 20- and 40-mg dosage strengths was already over, even though the company has not yet begun selling the products. The agency determined the exclusivity period was triggered Aug. 22, 2004, the date of an order dismissing a declaratory judgment filed against BMS by Apotex.

Teva sued the FDA in July 2005 following the agency's determination, which was founded on the assertion that a patent dispute between BMS and Apotex triggered Teva's 180-day exclusivity period for generic Pravachol (pravastatin sodium). This would have allowed all generic drugmakers to enter the market at once upon patent expiration, but now other firms will have to wait until Oct. 20 to launch their versions of Pravachol.

The suit, filed in the U.S. District Court for the District of Columbia, sought to reverse the FDA's decision and prevent the agency from approving generic drug applications filed by competing generic firms.

The FDA originally concluded that when BMS and Apotex agreed to dismiss a lawsuit over Pravachol in 2004 that dismissal qualified as a court decision that could trigger an exclusivity period. Under this rule, if the court terminates patent litigation involving a secondary challenger of a drug patent it can trigger the exclusivity period of the drug company that first challenged the patent. But in its revised decision, the FDA said the ruling in fact could not trigger exclusivity because the court did not address whether the patent was invalid, not infringed or unenforceable. (http://www.fdanews.com/did/5_73/)