FDA approves generic herpes drug

FDA approves Teva's generic version of Novartis' herpes drug Famvir; drugmakers still face day in court.

By Aaron Smith, CNNMoney.com staff writer

NEW YORK (CNNMoney.com) -- Teva Pharmaceuticals, the top-selling generic drugmaker in the world, said the FDA approved its generic version of Novartis' genital herpes drug Famvir.

But Novartis will still have its day in court.

Jerusalem-based Teva (up $0.71 to $41.56, Charts) said the Food and Drug Administration granted it 180-day exclusivity to produce a low-cost version of Novartis' (up $0.16 to $52.72, Charts) Famvir.

After the period of exclusivity ends, Famvir is fair game for other generic drugmakers, like Mylan Laboratories (up $0.12 to $15.14, Charts) and Barr Laboratories (up $0.16 to $52.22, Charts) of the U.S. and Ranbaxy Pharmaceuticals (down $0.18 to $8.48, Charts) and Dr. Reddy's Laboratories of India.

Famvir totaled $200 million in U.S. sales for Novartis during the 12 months ended June 30, 2007, according to Teva. But revenues for brand-name drugs plunge once they're pressured by generic competition.

Teva still faces a legal hurdle before launching its low-cost herpes pill, also known by its generic name, famciclovir. Swiss drugmaker Novartis sued Teva for patent infringement in 2005, and a hearing is scheduled for Sept. 5 in the U.S. District Court in New Jersey. Teva said it won't launch a generic version of Famvir until that hearing is concluded.

Famvir competes with GlaxoSmithKline's (up $0.45 to $52.03, Charts) herpes drug Valtrex. Top of page

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Market indexes are shown in real time, except for the DJIA, which is delayed by two minutes. All times are ET. Disclaimer LIBOR Warning: Neither BBA Enterprises Limited, nor the BBA LIBOR Contributor Banks, nor Reuters, can be held liable for any irregularity or inaccuracy of BBA LIBOR. Disclaimer. Morningstar: © 2012 Morningstar, Inc. All Rights Reserved. Disclaimer The Dow Jones IndexesSM are proprietary to and distributed by Dow Jones & Company, Inc. and have been licensed for use. All content of the Dow Jones IndexesSM © 2012 is proprietary to Dow Jones & Company, Inc. Chicago Mercantile Association. The market data is the property of Chicago Mercantile Exchange Inc. and its licensors. All rights reserved. FactSet Research Systems Inc. 2012. All rights reserved. Most stock quote data provided by BATS.