Thursday 10 January, 2008

Teva Drops Patent Suit Against Taro Over generic Carvedilol

Teva Pharmaceutical Industries Ltd. has dropped a patent infringement lawsuit against Taro Pharma over congestive heart drug failure treatment carvedilol. Teva filed a notice on Monday in the U.S. District Court for the Southern District of New York to dismiss the suit against Taro and its U.S. affiliate without prejudice. The suit was filed in June 2007, but Taro was never formally served. The deadline to serve the complaint was continually pushed back while the drug companies engaged in settlement negotiations. Terms of the deal were not disclosed. Taro currently has no plans to launch the product, said Roanne Kulakoff, a spokeswoman for Taro. At this time, there are a number of other players in the market so Taro has no plans to launch at this time.
A spokeswoman for Teva said the company had no comment. Taro was one of more than a dozen pharmaceutical companies targeted by Teva in suits over their plans to market generic versions of GlaxoSmithKline's drug Coreg. The lawsuits concern US6699997, US6710184, US7056942 and US7126008 all of which are owned by Teva. The patents cover carvedilol, the active ingredient in Coreg.
Carvedilol is a non-selective beta blocker indicated in the treatment of mild to moderate Congestive Heart failure(CHF). It is marketed under various Trade names like Coreg (GSK), Dilatrend (Roche) and Eucardic (Roche). Carvedilol is the only bata blocker which is(which reduce cardiomyopathy of heart muscle) used in CHF therapy.
After Glaxo's patent covering Coreg expired on March 5, the company was granted six months of pediatric exclusivity (PED). But Teva said in its lawsuits that the generic companies' plans to manufacture and sell Coreg's API to third parties constituted an imminent threat of infringement. In September, the USFDA approved 14 Abbreviated New Drug Applications for carvedilol including those from Taro, Actavis Elizabeth and Dr. Reddy's Laboratories after Glaxo's exclusivity period ended. Taro's ANDA sought to market generic versions of Coreg in four different dosages. Total sales of the drug (Coreg and Coreg CR) exceeded $1 billion in 2006-2007.

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Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
 
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