Royce Set To Market Captopril In 1995?
Royce Laboratories in the USA has won a legal dispute with Bristol-Myers Squibb in its bid to market a generic version of B-MS' Capoten (captopril) in the USA. The Food and Drug Administration is now free to approve Royce's Abbreviated New Drug Application for the product, and the firm could become the first to launch a generic.
B-MS sued Royce when the firm amended its ANDA to include a paragraph IV certification, stating it would not infringe B-MS' Capoten patents if it marketed the generic in the period between the old and new patent expiration dates put forward after GATT (Marketletters passim).
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