(Contd... from the earlier post. I hope this will provide good detail)
Teva Pharmaceutical Industries Ltd. has dropped a patent infringement lawsuit against Taro Pharmaceuticals Industries Ltd. 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 (as per the spokesperson)
The lawsuits concern U.S. Patent Numbers 6,699,997; 6,710,184; 7,056,942 and 7,126,008 all of which are owned by Teva. The patents cover carvedilol, the active ingredient in Coreg.
After Glaxo's patent covering Coreg expired on March 5, the company was granted six months of pediatric exclusivity. But Teva said in its lawsuits that the generic companies' plans to manufacture and sell Coreg's active pharmaceutical ingredient to third parties constituted an imminent threat of infringement.
In September, the U.S. Food and Drug Administration 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.
Many of the suits, such as the one against Taro, accused the generic drug makers
of not providing Teva information to determine whether the generic tablets would fall under the patent claims.
Glaxo's Coreg is a beta-blocker used to treat high blood pressure. From late 2006 to late 2007, total sales of the drug (Coreg and Coreg CR) exceeded $1 billion.
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