Navigation Links
Watson Files FDA Application for Generic LYBREL(R)
Date:3/13/2008

- Paragraph IV Patent Challenge Underway -

CORONA, Calif., March 13 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its Levonorgestrel and Ethinyl Estradiol tablets, USP (0.09 mg/0.02 mg) extended-cycle oral contraceptive product prior to the expiration of patents owned by Wyeth. Watson's Levonorgestrel and Ethinyl Estradiol product is a generic version of Wyeth's LYBREL(R) (levonorgestrel and ethinyl estradiol) tablets which is indicated for the prevention of pregnancy.

Wyeth filed suit against Watson on March 12, 2008 in the U.S. District Court, District of Delaware, seeking to prevent Watson from commercializing its product prior to the expiration of U.S. patent number 6,500,814. Wyeth's suit 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 or until final resolution of the matter before the court, whichever occurs sooner. Based on available information, Watson believes it may be the first applicant to file an ANDA for LYBREL(R) and, should its product be approved, may be entitled to 180 days of generic market exclusivity.

Forward-Looking Statement

Any statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Watson's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Watson's current expectations depending upon a number of factors affecting Watson's business. These factors include, among others, patents and other intellectual property rights held by competitors and other third parties and the uncertainty of the outcome of litigation related to such patents and intellectual property rights; the difficulty of predicting the timing or outcome of product development efforts and FDA or other regulatory agency approvals or actions; the impact of competitive products and pricing; market acceptance of and continued demand for Watson's products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Watson's periodic public filings with the Securities and Exchange Commission, including but not limited to Watson's Annual Report on Form 10-K for the year ended December 31, 2007. Lybrel(R) is a registered trademark of Wyeth.

(Logo: http://www.newscom.com/cgi-bin/prnh/20020214/WATSONLOGO)


'/>"/>
SOURCE Watson Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Barr Subsidiary Sues Watson for SEASONIQUE(R) Patent Infringement
2. Watson Pharmaceuticals Reports Fourth Quarter and Full Year 2007 Results; Provides 2008 Outlook
3. Watson to Present at the 2008 Merrill Lynch Global Pharmaceutical, Biotechnology and Medical Device Conference
4. Warner Chilcott and Watson Pharmaceuticals Announce Launch of Tilia(TM) Fe
5. Watson Receives FDA Approval for Generic Accuneb(R)
6. Watson to Present at the Bear Stearns 20th Annual Healthcare Conference
7. CryoCor Files Patent Infringement Lawsuits Against CryoCath
8. Omeros Corporation Files Registration Statement for Proposed Initial Public Offering
9. TAP Pharmaceutical Products Inc. Files New Drug Application for TAK-390MR in Patients with Acid-Related Disorders
10. Lexicon Files Investigational New Drug Application for LX1032 as a Potential Treatment for Carcinoid Syndrome
11. Roche Files IND for Second Genmab Antibody
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/3/2016)... 3, 2016 New Jersey Health Foundation (NJHF) ... million for researchers in New Jersey ... that demonstrates exciting potential.   James ... the New Jersey Health Foundation Research Grant Program ... educational institutions— Princeton University, Rutgers University, Rowan University ...
(Date:2/3/2016)... ... February 03, 2016 , ... StarNet Communications Corp, ... today announced the addition of a powerful “Session Preview” feature to its FastX ... state of the remote Linux desktop or other applications (sessions) they have running ...
(Date:2/3/2016)... 3, 2016  Today, Symphony Technology Group (STG) announced ... a leading provider of primary research and analytics-based insight ... Health , a global information and technology services company ... technologies will be integrated into IMS Health to form ... research capabilities. ...
(Date:2/3/2016)... ... February 03, 2016 , ... Marktech Optoelectronics, ... and wafers, and InP epi wafers based in Latham, New York, offers a ... transistors, and Avalanche photodiodes–to Si and InGaAs PIN photodiodes. But it is Marktech's ...
Breaking Biology Technology:
(Date:2/2/2016)... 2016 Technology Enhancements Accelerate Growth of X-ray Imaging ... digital and computed radiography markets in Thailand ... Indonesia (TIM). It provides an in-depth ... well as regional market drivers and restraints. The study ... and market attractiveness, both for digital and computed radiography. ...
(Date:2/1/2016)... , Feb. 1, 2016  Wocket® smart wallet ( www.wocketwallet.com ) announces ... personality, Joey Fatone . Las Vegas , ... --> Las Vegas , where Joey appeared ... The new video ad was filmed at the Consumer Electronics Show ... the Wocket booth to meet and greet fans. ...
(Date:1/22/2016)... January 22, 2016 ... addition of the  "Global Behavioral Biometric ... --> http://www.researchandmarkets.com/research/4lmf2s/global_behavioral ) has ... Behavioral Biometric Market 2016-2020"  report to ... and Markets ( http://www.researchandmarkets.com/research/4lmf2s/global_behavioral ) has announced ...
Breaking Biology News(10 mins):