Showing posts with label Mylan. Show all posts
Showing posts with label Mylan. Show all posts

Wednesday, February 16, 2011

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.

Wednesday, February 2, 2011

Mylan gets approval for Nisoldipine ER Tablets with 180 days exclusivity


Mylan Inc.has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Nisoldipine Extended-release Tablets, 8.5 mg, 17 mg, 25.5 mg and 34 mg. Earlier Mylan has developed the different strengths like 20 mg, 30 mg and 40 mg but later discontinued from the market. As Mylan was the first ANDA filer with paragraph IV certification against concerned patent listed in orange book for Sular® (Nisoldipine ER Tablets) of Shionogi Pharma, Mylan has the 180 days exclusivity to market the generic version of Sular® without any competition of other generics.

Nisoldipine ER Tablets are the generic version of Shionogi Pharma's Sular® Tablets, a treatment for hypertension. Nisoldipine ER Tablets had U.S. sales of approximately $103 million for the 12 months ending Sept. 30, 2010, according to IMS.

Thursday, January 27, 2011

Lipitor: One more settlement in patent litigation

The highest sold drug in US is Lipitor and generics are behind that to make business. Earlier this drugs's patent was challenged by many including Ranbaxy and as a results few settled the case with some kind of agreement and few lost the case.
Recently Mylan Inc. has settled the lawsuit related to Lipitor with Pfizer. This agreement is under th e review of FTC and terms of settlement is not disclosed yet.

Tuesday, October 5, 2010

Generic Wellbutrin XL is launched by Mylan

Wellbutrin XL is the brand name drug of GlaxoSmitkline having active ingredient Bupropion hydrochloride in extended release form.
Mylan pharmaceuticals has launched the 150 mg and 300 mg once daily tablets, generic version of Wellbutrin XL in US market on 1st october.