Navigation Links
Watson Files FDA Application for Generic LYBREL(R)

- 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.


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:
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... ... for two-dimensional representations of a complex biological network, a depiction of a system ... big mess,” said Dmitry Korkin, PhD, associate professor of computer science at Worcester ...
(Date:10/12/2017)... ... October 12, 2017 , ... AMRI, a global contract ... to improve patient outcomes and quality of life, will now be offering its ... attributed to new regulatory requirements for all new drug products, including the finalization ...
(Date:10/11/2017)... USA (PRWEB) , ... October 11, 2017 , ... ComplianceOnline’s ... take place on 7th and 8th June 2018 in San Francisco, CA. The Summit ... as well as several distinguished CEOs, board directors and government officials from around the ...
(Date:10/11/2017)... ... October 11, 2017 , ... ... implantation and pregnancy rates in frozen and fresh in vitro fertilization (IVF) ... and maternal age to IVF success. , After comparing the results from the ...
Breaking Biology Technology:
(Date:5/23/2017)... May 23, 2017  Hunova, the first robotic gym for the rehabilitation ... officially launched in Genoa, Italy . The first 30 ... and the USA . The technology was developed and ... by the IIT spin-off Movendo Technology thanks to a 10 million euro ... Release, please click: ...
(Date:4/24/2017)... , April 24, 2017 ... and partner with  Identity Strategy Partners, LLP (IdSP) ... "With or without President Trump,s March 6, 2017 ... Terrorist Entry , refugee vetting can be instilled with ... resettlement. (Right now, all refugee applications are suspended ...
(Date:4/13/2017)... April 13, 2017 UBM,s Advanced Design and ... will feature emerging and evolving technology through its 3D ... will run alongside the expo portion of the event ... and demonstrations focused on trending topics within 3D printing ... and manufacturing event will take place June 13-15, 2017 at ...
Breaking Biology News(10 mins):