Mylan Launches First Generic Version of Vfend® Tablets

Mylan Inc. has launched Voriconazole Tablets, 50 mg and 200 mg, under a previously announced settlement and license agreement with Pfizer Inc. As the Mylan was the first company who have filed a substantially complete ANDA containing a Paragraph IV certification for against Vfend Tablets, Mylan was awarded 180 days of marketing exclusivity.

Voriconazole Tablets are the generic version of Pfizer's Vfend® Tablets, a triazole antifungal agent. This product had U.S. sales of approximately $186 million for the 12 months ending Dec. 31, 2010, according to IMS Health.

Paragraph IV certification updated at USFDA

The list of Paragraph IV certification is updated by FDA as of January 17, 2011 and it includes 4 new listing as below..

1) Dexlansoprazole Capsules 60 mg (RLD-Dexilant) (Date-25 Aug 2010)
2) Dutasteride and Tamsulosin Hydrochloride Capsules 0.5 mg/0.4 mg (RLD-Jalyn) (Date-26 Oct 2010)
3) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral solution 17.5 g/3.13 g/1.6 g per bottle    (RLD-Suprep Bowel Prep Kit) (Date-08 Nov 2010)
4) Voriconazole Oral suspension (RLD-Vfend) (Date- 08 Oct 2010)

In my previous post i have mentioned about the suit by pfizer for Vfend (Voriconazole) against Novartis on filing ANDA with para IV certification for Vfend oral suspension.

Pfizer sues Novartis over Vfend (Voriconazole) antifungal patents

Pfizer Inc. has sued Novartis' Sandoz unit, claiming infringement of its U.S. patents related to the antifungal treatment Vfend which contains Voriconazole as active agent.

Pfizer alleges that Sandoz is seeking permission from the U.S. Food and Drug Administration to sell a generic version of Vfend before the expiration of two patents issued in 1994 and 2003, respectively.

Pfizer in its complaint filed with the U.S. district court in Wilmington, Delaware has sought the court’s order to block Sandoz from selling any version of Vfend before the patents expire.
(Source: http://www.itagbs.com/weekly_news.html)