Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) has received decisions on three products, as it awaits an impending decision on Protonix, a fourth drug.
On Wednesday, Teva announced that a US District Court in New Jersey denied a motion filed by Novartis for a preliminary injunction related to Teva's Famciclovir tablets, AB. Famciclovir is the generic equivalent of Novartis's shingles and genital herpes treatment Famvir.
Teva's abbreviated new drug application to market its Famciclovir tablets (in doses of 125 mg, 250 mg, and 500 mg) has already been granted final approval by the US Food and Drug Administration (FDA).
As the first company to file an abbreviated new drug application for Famciclovir, Teva has been awarded a 180-day period of marketing exclusivity, which will begin to run from the date of first commercial marketing.
Novartis had brought a patent infringement suit against Teva in April 2005 regarding the generic version, though a trial date has not been set. Teva had agreed not to launch a generic Famciclovir product until the conclusion of today’s hearing.
The brand product had annual sales of approximately $200 million in the US for the twelve months ended June 30, 2007, based on IMS sales data.
Separately, Forest Laboratories, Inc. and H. Lundbeck A/S of Denmark said that the US Court of Appeals for the Federal Circuit affirmed a 2006 decision which determined that the US patent covering the active ingredient in anti-depressant Lexapro is valid, and upheld the injunction preventing Teva subsidiary Ivax’s proposed generic product launch. The patent expires in 2012.
Today, Teva announced that the US Food and Drug Administration (FDA) has granted final approval for the company's abbreviated new drug application to market its generic version of GlaxoSmithKline plc's (NYSE: GSK) cardiovascular agent Coreg (Carvedilol). The company said that shipment of this product will begin immediately.
The brand product had $1.7 billion in US sales for the twelve months through June.
Teva will be back in court tomorrow to hear the outcome of its bid to launch a generic version of Wyeth's (NYSE: WYE) Protonix for the treatment of gastroesophageal reflux disease. Protonix has annual sales of around $2.5 billion.
Teva’s market cap hovers around $33.37 billion. Teva develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients.
Published by Globes [online], Israel business news - www.globes.co.il - on September 6, 2007
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