Apothecon captopril will be sole generic through Feb. 13 after Supreme Court denial of Royce appeal.
Executive Summary
APOTHECON GENERIC CAPTOPRIL EXCLUSIVITY RUNS UNTIL FEB. 13 AFTER SUPREME COURT refused to hear the case of Royce Labs v. Bristol-Myers Squibb Jan. 8. The generic manufacturer was seeking to overturn a Nov. 1 federal appeals court ruling upholding FDA's interpretation of the implementing legislation for the General Agreement on Tariffs & Trade, which granted Bristol six months of additional exclusivity for the ACE inhibitor Capoten, with the new patent term expiring Feb. 13. Bristol's Apothecon generics subsidiary introduced the first generic version of captopril Dec. 1 at a 15% discount to the brand.
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APOTHECON GENERIC CAPTOPRIL EXCLUSIVITY RUNS UNTIL FEB. 13 AFTER SUPREME COURT refused to hear the case of Royce Labs v. Bristol-Myers Squibb Jan. 8. The generic manufacturer was seeking to overturn a Nov. 1 federal appeals court ruling upholding FDA's interpretation of the implementing legislation for the General Agreement on Tariffs & Trade, which granted Bristol six months of additional exclusivity for the ACE inhibitor Capoten, with the new patent term expiring Feb. 13. Bristol's Apothecon generics subsidiary introduced the first generic version of captopril Dec. 1 at a 15% discount to the brand. Royce had been seeking to market captopril prior to Feb. 13 in exchange for "equitable remuneration" to Bristol. The Miami-based generic company won a decision in its favor in August but lost on appeal in November. The company acknowledged at the time it sought Supreme Court review that it was unlikely to reach the market before February ("The Pink Sheet" Nov. 6, 1995, T&G-1). Apothecon will have roughly 10 weeks to itself in the generic market before competition will intensify dramatically. Royce is one of a dozen companies poised to launch generic versions of Capoten after Feb. 13. Eleven firms have tentatively approved ANDAs (Royce, Novopharm, Mylan, Invamed, Mova, Hallmark, Copley, West-ward, Lemmon, Par and Endo); Ciba's Geneva division has a fully- approved ANDA that was approved after Bristol neglected to sue the company for patent infringement. However, under a settlement agreement, Geneva has not gone to market ("The Pink Sheet" Dec. 4, 1995, T&G-5). After the high court action, the only way any company could come to market before Feb. 13 would be via a legislative remedy of the type advocated by Sen. Pryor (D-Ark.). Pryor came within one vote of passing the bill in the Senate in December ("The Pink Sheet" Dec. 11, 1995, T&G-7). In light of that defeat and the absence of companion legislation in the House, the prospects for short-term enactment of the bill appear remote. |