Novopharm Brings Generic Ranitidine To The Market

8 July 1997

A US Federal Court ruled on July 3 that Novopharm USA, a subsidiary ofNovopharm of Canada, could begin selling generic ranitidine hydrochloride, which Glaxo Wellcome of the UK markets as Zantac, on July 10. The ruling mandated that the US Food and Drug Administration give Novopharm its final approval on the drug and reversed its earlier decision to award exclusivity to Genpharm, a subsidiary of the German firm Merck KGaA (Marketletter June 30).

The ruling stated: "Here, neither Geneva (a subsidiary of Novartis of Switzerland - Ed) nor Genpharm, nor any other pharmaceutical company, submitted the first Abbreviated New Drug Application for a generic version of Zantac that included a paragraph IV certification, and successfully defended a suit by GW for patent infringement."

Leslie Dan, chairman and chief executive of Novopharm, said: "it's been the battle of the century for the pharmaceutical industry, and we are thrilled that Novopharm has finally emerged the winner." The firm planned to have its product available in US pharmacies on July 10, as agreed with GW, a full 16 days prior to patent expiration on July 25.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK



Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight