Wednesday 22 April, 2009

Carvedilol (Coreg): Teva settled with Glenmark on API process patents

Refer to our earlier post on carvedilol (Coreg) Here and Here, wherein, Teva dropped API process patent infringement charges against Dr. Reddy and Taro, now, Teva has settled with another generic player Glenmark ( also, refer to Livemint news on this litigation) and dropped infringement charges.
The lawsuits concern following patents which covers Carvedilol API manufacturing process:

US6699997 (Assignee: Teva, Date of Grant: March 2, 2004) : Which covers A process for preparing carvedilol comprising a step of reacting a compound of formula II, 4-(oxiran-2-ylmethoxy)-9H-carbazole with a compound of formula III, 2-(2-methoxyphenoxy)ethylamine, wherein, the compound of formula III and the compound of formula II are at a molar ratio of from about 2.8:1 to about 10:1.
US7126008 (Assignee: Teva, Date of Grant: October 24, 2006 ): Which covers a process for preparing carvedilol comprising a step of reacting a compound of formula II, 4-(oxiran-2-ylmethoxy)-9H-carbazole with a compound of formula III, 2-(2-methoxyphenoxy)ethylamine, wherein, the compound of formula III is at a molar excess over the compound of formula II.
Teva filed a notice in the U.S. District Court of New Jersey to dismiss the suit against Glenmark without prejudice.
After innovator GSK’s product patent on Carvedilol expired in 2007, more than dozen generic companies have developed their generic product and got USFDA approval. Further, Teva has aggressively asserted its patent on process to snub other generic players to continually monopolize market on this product.

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.

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