LILLY TO MARKET FOUR ANDAed DOSAGE FORMS OF CEFUROXIME (GLAXO's ZINACEF)

Executive Summary

LILLY TO MARKET FOUR ANDAed DOSAGE FORMS OF CEFUROXIME (GLAXO's ZINACEF) under the same non-exclusive license that allowed the firm to challenge Glaxo's exclusive marketing of ceftazidime. On Jan. 10, Lilly received three separate antibiotic Form 6 ANDA approvals for different dosage forms of cefuroxime to be marketed under the brandname Kefurox. Subsequently, on Jan. 15, Lilly received an additional approval for cefuroxine in Abbott's Add-Vantage system. Lilly indicated that neither a launch date nor pricing have been finalized. Cefuroxime represents Lilly's second ANDA approval of a Glaxo third generation cephalosporin in the past three months. Shortly after Glaxo introduced Fortaz (ceftazidime) last July, Lilly went the ANDA route with its own ceftazidime product, Tazidime, under a 1969 cross-licensing agreement with Glaxo. Despite a Glaxo citizen petition to FDA contending that ceftazidime exclusivity was implicitly covered by Title I of the Waxman/Hatch Law, Lilly received Tazidime approval Nov. 20 ("The Pink Sheet" Nov. 25, p. 5). At an April 1985 analysts meeting, Glaxo announced its intention to file for an oral form of cefuroxime ("The Pink Sheet" April 15, p. 12). The application is now pending. Lilly is also asserting that rights to the oral form should also be provided by the 1969 nonexclusive Lilly/Glaxo agreement.