Novopharm has begun marketing its generic version of Glaxo Wellcome's Zantac through a commercial agreement with Genpharm. FDA approved Novopharm's ranitidine tablets on July 31.

Through the agreement, Genpharm agreed to share its generic exclusivity period with Novopharm. The exclusivity period runs through Aug. 29. Financial terms of the agreement were not disclosed. Genpharm and Mylan previously announced an exclusive distribution agreement for ranitidine. However, that deal did nothing to bring the product to market, since both remain locked in Form 1 ranitidine patent litigation brought by Glaxo ("The Pink Sheet" July 28, T&G-1).

The agreement followed the Richmond, Va. appeals court's July 23 decision not to lift the stay it had put on a federal court order for FDA to approve Novopharm's product in time for a July 10 launch under a licensing agreement with Glaxo. The appeals court's decision had the effect of putting exclusivity back in Genpharm's hands until the court would reconsider the issue late in September. FDA decided June 17 that, to be consistent with the ruling in Mova v. FDA, Genpharm had the right to exclusivity ("The Pink Sheet" June 23, p. 3).

Glaxo earned roughly $100 mil. from Zantac sales during the three-week delay in the launch of the Novopharm generic. The company told a July 31 press conference in London that Zantac U.S. sales were averaging $5 mil. per day through the first six months of the year.

While the Novopharm/Genpharm agreement ends Glaxo's exclusivity for ranitidine, the company will still benefit from a delay in additional generic launches until the end of August. Before the FDA exclusivity ruling, Glaxo was prepared to allow Novopharm to launch a generic on July 10 with the expectation that other companies would enter the market July 26.

Geneva and Boehringer Ingelheim are the only other firms currently eligible to market ranitidine once the exclusivity period ends. Boehringer Ingelheim prevailed in patent litigation brought by Glaxo, and although Geneva is still in litigation, the 30-month Waxman/Hatch waiting period has expired. Geneva maintained that Genpharm also approached it about a commercial agreement, but claimed Genpharm wanted too much compensation.

Novopharm had more invested in generic ranitidine than Geneva. The company built a production facility in North Carolina to supply the product, and also paid Glaxo an upfront licensing fee for the right to launch July 10. The delay in marketing because of FDA's decision did not entitle Novopharm to receive the money back from Glaxo, the company said.

Glaxo CEO Richard Sykes told the press conference that worldwide sales of Zantac fell 12% to $1.32 bil. in the first six months of 1997. Sykes attributed the decline to "normal competitive pressures" from other H2 antagonists, proton pump inhibitors and OTC acid suppressers.

NOVOPHARM MARKETING GENERIC RANITIDINE THROUGH AGREEMENT WITH GENPHARM; THREE-WEEK DELAY BRINGS GLAXO $100 MIL. IN ADDITIONAL ZANTAC SALES

More from Archive

More from Pink Sheet