It's Prilosec time for Andrx, Genpharm

Companies set aside dispute on generic prescription antacid

It's Prilosec time for two companies vying to become the first to market a generic version of the popular antacid. On January 2, Andrx Group (Fort Lauderdale, FL) and Genpharm Inc. (San Jose, CA) agreed to end their dispute over who was the first to file an abbreviated new drug application (ANDA) for generic of Prilosec. The two companies drafted a memorandum of understanding that established Andrx as first-filer.

At stake was 180 days of market exclusivity typically granted first-filers—a status assigned to Andrx by the U.S. Food and Drug Administration but questioned by Genpharm. The dispute arose from Genpharm's belief that FDA improperly refused to accept the filing of its earlier ANDA submission.

Under terms of their memorandum, which still must be reviewed by FDA, Andrx will market a bioequivalent form of Prilosec first. However, through cross-licenses, both will share the revenues regardless of who gets to market first. If Andrx's claim to first-filer status is upheld, it will share 15% of profits with Genpharm during early marketing stages. If at least three generic versions of Prilosec eventually hit the market, this royalty will be reduced to 10% for a four-year period, and will then be eliminated.

Alan P. Cohen, co-chairman and CEO of Andrx, said, "We are of course pleased to have resolved this issue with Genpharm. The memorandum allows Andrx and Genpharm to focus our joint efforts on making a generic version of Prilosec available to U.S. consumers as soon as legally and prudently possible."

Over the past year AstraZeneca (Wayne, PA), which markets Prilosec, has conducted an all-out direct-to-consumer media blitz to build name recognition for its branded anti-heartburn product. Radio ads direct consumers to a website, "www.purplepill.com," which vaguely reminds this 40-something writer of the "little yellow pill" from a Rolling Stones song from 35 years ago. Why not incorporate the drug name in the website address? It turns out that "www.prilosec.com" belongs to a Swedish firm, Control Alt Delete (Stockholm).

For more information: Elliot F. Hahn, President, Andrx Corp., 4955 Orange Dr., Davie, FL 33314. Tel: 954-584-0300.

By Angelo DePalma
Managing Editor, Pharmaceutical Online and Drug Discovery Online
Email: adepalma@vertical.net