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.You may also be interested in...
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