Navigation Links
Mylan Launches First Generic Version of Entocort EC® Capsules
Date:6/23/2011

PITTSBURGH, June 23, 2011 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that the U.S. District Court for the District of Delaware has found after trial that Mylan subsidiary Mylan Pharmaceuticals Inc. does not infringe the asserted claims of U.S. Patent No. 5,643,602 with its Abbreviated New Drug Application (ANDA) for Budesonide Capsules, 3 mg (Enteric Coated), the generic version of AstraZeneca's Entocort EC® capsules, a treatment for Crohn's disease.  

Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Budesonide Capsules, 3 mg, ANDA on May 16. This is the first generic version of this product to be introduced to the U.S. market, and Mylan Pharmaceuticals will be shipping this product immediately.

Budesonide Capsules, 3 mg, had U.S. sales of approximately $350 million for the 12 months ending March 31, 2011, according to IMS Health.

Currently, Mylan has 164 ANDAs pending FDA approval representing $94.2 billion in annual sales, according to IMS Health. Forty-five of these pending ANDAs are potential first-to-file opportunities, representing $25.8 billion in annual brand sales, for the 12 months ending Dec. 31, 2010, according to IMS Health.

Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 150 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies. For more information about Mylan, please visit www.mylan.com. For more information about generic drugs, please visit www.ChoosingGenerics.com.


'/>"/>
SOURCE Mylan Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Mylan Receives Approval for Generic Version of Aricept® Tablets
2. Mylan Receives Approval for Generic Version of Effexor XR® Capsules
3. Mylan Launches Generic Version of Roxicodone® Tablets
4. Mylan Launches Generic Version of Depakote® Sprinkle Capsules
5. Mylan Launches First Generic Version of Xibrom® Ophthalmic Solution
6. Mylan Launches First Generic Version of Amrix® Capsules
7. Mylan Launches Generic Version of Risperdal® M-Tab®
8. Mylan Launches First Generic Version of Femara® Tablets
9. Mylan Launches Generic Version of Famvir® Tablets
10. Mylan Receives Approval for Generic Version of Xalatan® Ophthalmic Solution
11. Mylan Announces Exclusive Distribution Partnership with Humeca to Expand Burn and Wound Care Portfolio
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/27/2017)... MIAMI , Sept. 27, 2017  Commended for their ... recent notable awards. Ranked as number one in the South ... ninth time in Inc. 5000 yearly list, the national specialty ... CEO, Armando Bardisa will soon be honored by ... Set to receive his award ...
(Date:9/22/2017)... 22, 2017  As the latest Obamacare repeal effort ... Cassidy (R-LA) and Lindsey Graham (R-SC) ... medical device industry is in an odd place.  The ... 2.3% excise tax on medical device sales passed along ... covered patients, increased visits and hospital customers with the ...
(Date:9/18/2017)... 18, 2017 EpiVax, Inc. ("EpiVax") ... and immune engineering, today announced a new ... (H7N9) vaccine. ... influenza and presents a challenge for traditional ... to be effective. Using state-of-the-art bioinformatics and molecular ...
Breaking Medicine Technology:
(Date:10/12/2017)... ... October 12, 2017 , ... Leading pediatric oncology experts at ... for the 49th Congress of the International Society of Paediatric Oncology (SIOP) ... Center for Cancer and Blood Disorders at Children’s National, and Stephen P. ...
(Date:10/12/2017)... ... October 12, 2017 , ... Women-owned and ... 2017 Best and Brightest in Wellness® by Best and Brightest. OnSite Wellness will ... Friday, Oct. 20 from 7:30 a.m. to 2 p.m. at the Henry Autograph ...
(Date:10/12/2017)... BALTIMORE (PRWEB) , ... October 12, 2017 , ... ... average of $3,296 in property taxes a year. In some states—like New York, ... higher. , By contrast, many overseas retirement havens have extremely low property-tax rates, ...
(Date:10/12/2017)... ... October 12, 2017 , ... Farm Forward ... Berkeley, and other leading institutions in announcing the launch of the Leadership ... the way animals are raised for food. , Founding members of the Leadership ...
(Date:10/12/2017)... Texas (PRWEB) , ... October 12, 2017 , ... ... and biologics manufacturer, has expanded its executive staff with the addition of industry ... In this role, Slott will develop the national distribution and sales network, direct ...
Breaking Medicine News(10 mins):