GW Appeals Generic Zantac Decision

Glaxo Wellcome is appealing the US court decision given on July 5 to Canadian pharmaceutical company Novopharm regarding the marketing of generic Zantac (ranitidine; Marketletter July 15), GW's antiulcerant.

The judge ruled in Novopharm's favor, saying that a generic version of Form 1 Zantac can be produced without infringing the Form 2 patent. GW has lodged the appeal with the US Court of Appeals for the Federal Circuit in Washington, and will be seeking an expedited appeal; a hearing date will be set in due course.

Will Start Producing December? Despite the appeal, Novopharm intends to proceed with the manufacture of the drug on December 11, 1996. Citing a clause in the US Hatch-Waxman Act of 1984, which states that brand-name drug manufacturers may not delay generic makers from producing their lower-cost equivalents for more than 30 months, Novopharm said that it will begin making Form 1 generic Zantac later this year. The product will be produced at its $38 million facility in North Carolina, built specifically for the manufacture of the drug.