Navigation Links
Watson Confirms Lo Loestrin® Fe Patent Challenge
Date:5/18/2012

PARSIPPANY, N.J., May 18, 2012 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Norethindrone Acetate/Ethinyl Estradiol and Ethinyl Estradiol and Ferrous Fumarate Tablets,1 mg/0.01 mg and 0.01 mg and 75 mg. Watson's ANDA product is a generic version of Warner Chilcott Company LLC's Lo Loestrin® Fe which is indicated for use by women to prevent pregnancy.

Warner Chilcott Company, LLC filed suit against Watson on May 16, 2012, in the United States District Court for the District of New Jersey seeking to prevent Watson from commercializing its ANDA product prior to the expiration of U.S. Patent Nos. 5,552,394 and 7,704,984. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA for up to 30 months from the date the plaintiff received notice of Watson's ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.

For the twelve months ending March 31, 2012, Lo Loestrin® Fe had total U.S. sales of approximately $86 million according to IMS Health data.

About Watson Pharmaceuticals, Inc.Watson Pharmaceuticals, Inc. is an integrated global specialty pharmaceutical company. The Company is engaged in the development, manufacturing, marketing and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on Urology and Women's Health. The Company is also developing biosimilar products in Women's Health and Oncology. Additionally, Watson distributes generic and branded pharmaceuticals through its Anda, Inc. distribution business. Watson has operations in many of the world's established and growing international markets.

For press release and other company information, visit Watson Pharmaceuticals' Web site at http://www.watson.com.

Forward-Looking Statement Statements contained in this press release that refer to non-historical facts are forward-looking statements that reflect Watson's current perspective of existing information as of the date of this release. It is important to note that Watson's goals and expectations are not predictions of actual performance. Actual results may differ materially from Watson's current expectations depending upon a number of factors, risks and uncertainties affecting Watson's business. These factors include, among others, the difficulty of predicting the timing or outcome of product development efforts, including FDA and other regulatory agency approvals and actions, if any; the difficulty of predicting the timing and outcome of the pending patent litigation; the impact of competitive products and pricing; the timing and success of product launches; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA and other governmental regulations applicable to Watson and its third party manufacturers' facilities, products and/or businesses; changes in the laws and regulations, including Medicare and Medicaid, affecting among other things, pricing and reimbursement of pharmaceutical products; and such other risks and uncertainties detailed in Watson's periodic public filings with the Securities and Exchange Commission, including but not limited to Watson's Quarterly Report on Form 10-Q for the quarter ended March 31, 2012 and Watson's Annual Report on Form 10-K for the year ended December 31, 2011. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.

Lo Loestrin® is a registered trademark of Warner Chilcott Company, LLC.

(Logo: http://photos.prnewswire.com/prnh/20100121/LA41294LOGO )CONTACTS: Investors:Lisa DeFrancesco (862) 261-7152Media:Charlie Mayr(862) 261-8030


'/>"/>

SOURCE Watson Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Watson to Present at the Bank of America Merrill Lynch 2012 Health Care Conference
2. Watson Names Lisa DeFrancesco Vice President, Global Investor Relations
3. Watson to Acquire Actavis Group for EUR4.25 Billion
4. Watson to Host Conference Call and Webcast to Discuss First Quarter 2012 Earnings
5. Taconic IPAs Annette Watson to present at PCPCC meeting
6. Watson Launches Generic FORTAMET(R)
7. Auxilium Pharmaceuticals, Inc. and FCB I LLC Receive Paragraph IV Certification Notice from Watson Laboratories, Inc. for Testim®
8. Watson Confirms Favorable District Court Ruling in Generic Sanctura XR® Patent Suit
9. Watson Partners With March of Dimes to Help Fight Preterm Birth
10. Watson Confirms NIASPAN(R) Patent Challenge
11. Watson Confirms BYSTOLIC(R) Patent Challenge
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/17/2017)... , Aug. 17, 2017 Bio-Ess Laboratories, LLC Chief Science Officer, ... titer and present new data on Cell-Ess® Universal Titer Boost ... Boston, MA August 21-25.  The Bioprocessing Summit convenes more ... challenges. ... ...
(Date:8/15/2017)...  Axium Pharmaceuticals Inc., the creator of the drug Truveta ... stages of an IPO. The United States ... cost of a prescription epilepsy drug being $450.00-$1200.00 for a one month ... AXIUM PHARMACEUTICALS, INC ... Another staggering figure is the fact that Americans spent $42 billion on ...
(Date:8/14/2017)... PETACH TIKVAH, Israel , Aug. 15, ... leading developer of adult stem cell technologies for neurodegenerative ... June 30, 2017. ... our pivotal Phase 3 trial to investigate NurOwn ® ... and Chief Executive Officer of BrainStorm. "We have agreements ...
Breaking Medicine Technology:
(Date:8/21/2017)... (PRWEB) , ... August 21, 2017 , ... The American ... Network (AHN), a Highmark Health company, to its Board of Trustees for a ... not-for-profit association of health care provider organizations and individuals that are committed to the ...
(Date:8/20/2017)... ... 20, 2017 , ... A total solar eclipse will occur across the U.S. on ... moon moves between the sun and Earth. This rare event will be magnificent to witness, ... keep you safe on the road during the total eclipse of the sun. , 1. ...
(Date:8/19/2017)... ... August 19, 2017 , ... ... Jr., will feature the Aurum Group in an upcoming episode, slated to air ... of Innovations will feature the Aurum Group; a company committed to supporting dentistry ...
(Date:8/19/2017)... New York, New York (PRWEB) , ... August ... ... Fruit Street Health has announced that it is the first organization with pending ... the CDC’s National Diabetes Prevention Program (“DPP”) via group telehealth classes and live ...
(Date:8/19/2017)... NJ (PRWEB) , ... August 19, 2017 , ... ... Park, NJ, is a diverse community of over 1,000 passionate employees, caregivers, volunteers, ... aging. After Parker at Stonegate changed ownership, it was time to refresh the ...
Breaking Medicine News(10 mins):