Generic Ranitidine Finally Reaches US Market

Glaxo Wellcome's exclusivity for its H2 receptor antagonist Zantac(ranitidine) in the USA came to an end on July 31, after an agreement was finally reached in the negotiations surrounding the introduction of generic forms, opening the way for US Food and Drug Administration approval of Novopharm's version.

The launch was made possible after Novopharm of Canada and Merck KGaA subsidiary Genpharm agreed to share the exclusivity period (to August 29) afforded under the Waxman-Hatch Act. Genpharm had previously entered into an agreement with Mylan to bring a generic to market, but the firms were unable to do so because of ongoing patent litigation with GW over the Form 1 version of the drug, and the fact that Genpharm's 30-month period from the time the litigation process started has not expired (Marketletters passim).

Long And Winding Road Novopharm was the first generics house to be in a position to market generic ranitidine after it signed a deal with GW back in May giving it the right to market its version on July 10, in advance of the July 25 Form 1 patent expiry. However, shortly thereafter, the FDA muddied the waters by also granting a temporary approval to Genpharm to market generic ranitidine (Marketletter June 30).