NOVOPHARM FILES ANDA FOR RANITIDINE

Novopharm has filed an Abbreviated New Drug Application with the US Food and Drug Administration for a Form 1 version of ranitidine hydrochloride, a different crystalline form of Glaxo's Form 2 ranitidine hydrochloride (Zantac).

In accordance with the provisions of the Waxman-Hatch Act, said Glaxo, the applicant (Novopharm) has certified to Glaxo that it will not market its product prior to the expiration in December 1995 of Glaxo's basic US patent on ranitidine hydrochloride. In addition, said Glaxo, the applicant claims that the active ingredient in its product is Form 1 and therefore would not infringe Glaxo's US patent on Form 2 which expires in 2002.

Much of the problem for Glaxo, according to industry observers, is that its patent rights for ranitidine are somewhat unclear. Glaxo holds two patents on Form 1 and Form 2, and has always produced the drug in Form 2. It has always insisted that it is impossible to make a Form 1 version without breaching its Form 2 patent. However, Novopharm and Geneva, a subsidiary of Ciba which filed an FDA application for approval of a generic ranitidine in March, both claim that they can produce the Form 1 compound without violating Glaxo's later patent. Glaxo's patent status, which was upheld in a dispute with Novopharm earlier this year, is still under challenge from Canadian drug maker Genpharm.