BASINGSTOKE, England, Jan. 14 /PRNewswire-FirstCall/ -- Shire Pharmaceuticals Group plc announces that its subsidiary Shire Laboratories Inc. has served Nostrum Pharmaceuticals, Inc. (“Nostrum”) with a complaint for patent infringement of Shire Laboratories’ U.S. Patent Nos. 5,912,013 (“‘013 Patent”) and 5,326,570 (“‘570 Patent”). The complaint was filed in the U.S. District Court for the District of New Jersey.
The lawsuit results from an ANDA (Abbreviated New Drug Application) filed by Nostrum for a generic version of the 300 mg dosage strength of CARBATROL(R), pursuant to which Nostrum provided notice that it would seek to market its generic product before the expiration of the ‘013 and ‘570 Patents.
CARBATROL(R) is Shire’s leading extended-release medication for the treatment of epilepsy.
Notes: Shire Pharmaceuticals Group plc
Shire Pharmaceuticals Group plc (Shire) is a global specialty pharmaceutical company with a strategic focus on meeting the needs of the specialist physician and currently focuses on developing projects and marketing products in the areas of central nervous system (CNS), gastrointestinal (GI), and renal diseases. Shire has operations in the world’s key pharmaceutical markets (US, Canada, UK, France, Italy, Spain and Germany) as well as a specialist drug delivery unit in the US.
For further information on Shire, please visit the Company’s website: http://www.shire.com/
The “Safe Harbor” Statement Under The Private Securities Litigation Reform Act Of 1995
Statements included herein that are not historical facts, are forward- looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire’s results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with the inherent uncertainty of pharmaceutical research, product development, manufacturing and commercialization, the impact of competitive products, including, but not limited to, the impact on Shire’s Attention Deficit Hyperactivity Disorder (ADHD) franchise, patents, including but not limited to, legal challenges relating to Shire’s ADHD franchise, government regulation and approval, including but not limited to the expected product approval date of lanthanum carbonate (FOSRENOL(R)), METHYPATCH(R), XAGRID(R) and the adult indication for ADDERALL XR(R) and other risks and uncertainties detailed from time to time in our filings, including the Annual Report filed on Form 10-K by Shire with the Securities and Exchange Commission.
Shire Pharmaceuticals Group plc
CONTACT: Media, Jessica Mann, or Investors, Clea Rosenfeld, both of ShirePharmaceuticals Group plc, +44-1256-894-160
Web Site: http://www.shire.com/
