Navigation Links
Mylan Confirms First-to-File Patent Challenge Relating to Generess™ Fe

PITTSBURGH, Dec. 1, 2011 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today confirmed that it and Famy Care Ltd. have been sued by Warner Chilcott Company LLP, in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Norethindrone and Ethinyl Estradiol Chewable Tablets, 0.8 mg/0.025 mg and Ferrous Fumarate Chewable Tablets. This product is the generic version of Generess™ Fe, a 28-day regimen indicated for use by women to prevent pregnancy.

Mylan believes that this application submitted to the FDA is the first substantially complete ANDA containing a Paragraph IV certification and expects it to qualify for 180 days of marketing exclusivity upon final approval. In 2008, Mylan and Famy Care entered into a partnership to develop and supply oral contraceptives. Warner Chilcott filed the lawsuit in the U.S. District Court for the District of New Jersey.

Since launching in April 2011 and through Sept. 30, 2011, Generess Fe had sales of $4.5 million, according to IMS Health.

This press release includes statements that constitute "forward-looking statements," including with regard to the expected first-to-file status and pending litigation. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the use of legal, regulatory and legislative strategies by competitors or other third parties to delay or prevent product introductions; risks inherent in legal and regulatory processes; and the other risks detailed in the company's filings with the Securities and Exchange Commission. The company undertakes no obligation to update these statements for revisions or changes after the date of this release.

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 For more information about generic drugs, please visit

SOURCE Mylan Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Mylan Committed to Expanding Access in Developing Countries to High Quality, Affordable HIV/AIDS Treatment
2. Mylan Receives Approval for Generic Version of Zinecard® for Injection
3. Mylan Announces Settlement Agreement for its First-to-File Generic Version of Vivelle-Dot®
4. Mylan Successfully Upsizes and Completes Refinancing of Credit Facility
5. Mylan Applauds Obama Administrations Call to Create an "AIDS-Free Generation" Through Global Fight Against HIV/AIDS
6. Mylan to Acquire Pfizer Respiratory Delivery Platform
7. Mylan Receives Approval for Generic Version of MS Contin® Tablets
8. Mylan Launches First Generic Version of Exelon® Capsules in the U.K.
9. Mylans Dey Pharma Successfully Obtains Patent Reexamination Certificates for Two Perforomist® Patents
10. Matrix Laboratories Completes Name Change to Mylan Laboratories
11. Mylan Announces Femcon® Fe Settlement Agreement
Post Your Comments:
(Date:11/26/2015)... DUBLIN , November 26, 2015 /PRNewswire/ ... the addition of the "2016 Future ... Drugs of Abuse Testing Market: Supplier Shares, ... report to their offering. --> ... of the "2016 Future Horizons and ...
(Date:11/26/2015)... , November 26, 2015 ... --> adds "Global Repaglinide ... "Investigation Report on China Repaglinide Market, ... forecasts data and information to its ... . --> ...
(Date:11/26/2015)... DUBLIN , November 26, 2015 ... has announced the addition of the  ... in the European Cell Surface Marker ... Emerging Opportunities"  report to their offering.  ... announced the addition of the  "2016 ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... November 27, 2015 , ... Indosoft Inc., developer ... incorporation of Asterisk 11 LTS (Long Term Support) into its Q-Suite 5.10 product ... Q-Suite 5.10 up-to-date with a version of Asterisk that will receive not only ...
(Date:11/26/2015)... ... 2015 , ... Inevitably when people think Thanksgiving, they also think Holiday sales ... Black Friday and Cyber Monday massage chair sales to receive the best ... low to find the best massage chair deals, they can see all of the ...
(Date:11/26/2015)... ... November 26, 2015 , ... Somu Sivaramakrishnan ... a franchise owner, Somu now offers travelers, value and care based Travel Services, ... cruise sales, as well as, cabin upgrades and special amenities such as, shore ...
(Date:11/26/2015)... , ... November 26, 2015 , ... Jobs in hospital ... healthcare professionals and offered by healthcare staffing agency Aureus Medical Group . ... month of October 2015 among those searching for healthcare jobs through the company’s website, ...
(Date:11/26/2015)... BOSTON, Mass. (PRWEB) , ... November 26, 2015 ... ... a thorough second medical opinion process, participated in the 61st annual Employee Benefits ... Benefit Plans and took place Sunday, November 8th through Wednesday, November 11th, 2015. ...
Breaking Medicine News(10 mins):