- Paragraph IV Litigation Underway -
MORRISTOWN, N.J., July 15 /PRNewswire-FirstCall/ -- Watson
Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company,
today confirmed that its subsidiary, Watson Laboratories, Inc.-Florida
("Watson"), has filed an Abbreviated New Drug Application (ANDA) with the U.S.
Food and Drug Administration seeking approval to market its trospium chloride
extended-release 60 mg capsules prior to the expiration of a patent owned by
Supernus Pharmaceuticals, Inc. Watson's trospium chloride extended-release
capsules are the generic version of Allergan Inc.'s Sanctura XR product,
which is indicated for the treatment of overactive bladder (OAB) with symptoms
of urge urinary incontinence, urgency and urinary frequency.
Allergan filed suit against Watson on July 13, 2009 in the U.S. District
Court for the District of Delaware seeking to prevent Watson from
commercializing its products prior to expiration of U.S. patent number
7,410,978. Allergan'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
Watson believes it may be first to file an ANDA for generic trospium
extended-release capsules. For the twelve-months ended March 31, 2009,
Sanctura XR had total U.S. sales of approximately $42 million, according to
IMS Health data.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc. is a global leader in the development and
distribution of pharmaceuticals with a broad portfolio of generic products and
a specialized portfolio of brand pharmaceuticals focused on Urology, Women's
Health and Nephrology/Medical.
For press release and other company information, visit Watson
Pharmaceuticals' Web site at http://www.watson.com.
Watson's 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, the difficulty of predicting the timing or outcome of FDA
approvals or actions, if any; the difficulty of predicting the timing or
outcome of litigation related to patent infringement; the impact of
competitive products and pricing; market acceptance of and continued demand
for Watson's products; 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, 2008.
SOURCE Watson Pharmaceuticals, Inc.
of Watson Pharmaceuticals, Inc.,
Web Site: http://www.watson.com