Norwich Eaton's Buprenex
U.S. Patent & Trademark Office determined that Buprenex (buprenorphin HCl) injection is not eligible for patent term extension since an application for extension wa submitted (Aug. 26, 1985) more than 60 days after the product was approved for commercial marketing (Dec. 29, 1981). Norwich Eaton has filed a suit against HHS and FDA seeking a court judgment that the drug was not approved until June 28, 1985, or alternatively, not until Jan. 8, 1982 ("The Pink Sheet" Jan. 20, p. 7).
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