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NOVOPHARM FILES ANDA FOR GENERIC AZT, EXPANDS PATENT CHALLENGE TO U.S.

Executive Summary

NOVOPHARM FILES ANDA FOR GENERIC AZT, EXPANDS PATENT CHALLENGE TO U.S., the firm announced Aug. 24. Novopharm Inc., the Schaumburg, Ill.-based subsidiary of the Canadian firm Novopharm Ltd., filed the ANDA on June 29. The company said it intends to inform Burroughs Wellcome, marketer of the innovator AZT (Retrovir), that it will challenge Burroughs' patent for the AIDS drug. Burroughs' patent for use of AZT for treatment of AIDS expires on Feb. 9, 2005. Novopharm Ltd. already is challenging Burroughs' patent in Canada. Novopharm's generic AZT recently was cleared for marketing in Canada. Another Canadian manufacturer of AZT, Apotex, is also contesting the patent in Canada. Burroughs has said that it does not expect those cases to go to trial before 1994 ("The Pink Sheet" June 22, p. 16). Novopharm predicted that FDA's draft policy for expedited review of blockbuster generic drugs "will help speed the drug's market entry." The company is awaiting approval from the National Institutes of Health for a nonexclusive license to use AZT as an AIDS treatment. Novopharm maintains that AZT's use in treating AIDS was discovered by NIH researchers, not by Burroughs, and says that Burroughs "omitted" that information in its patent filings. Novopharm will have to get in line with at least one other manufacturer with regard to generic AZT: Barr Labs has had an ANDA for a generic AZT pending at FDA since March 19, 1991 and is also challenging Burroughs' patent. Burroughs anticipates that the Barr case will not begin before May 1993. Approval of Barr's AZT may be delayed by fallout from FDA inspections of the company. Following temporary suspension of a trial in Newark federal court, Barr and FDA are in settlement negotiations over the generic firm's alleged good manufacturing practice problems.
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