Healthcare Industry News:  Adderall XR 

Biopharmaceuticals Generics Litigation

 News Release - November 10, 2006

Shire Sues Andrx Pharmaceuticals, L.L.C.

BASINGSTOKE, England and PHILADELPHIA, Pennsylvania, November 10 (HSMN NewsFeed) -- Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announces that its subsidiary Shire Laboratories Inc. has filed lawsuits in the US District Court for the District of New Jersey and the Southern District of Florida against Andrx Pharmaceuticals, L.L.C. and Andrx Corporation (collectively "Andrx") for infringement of Shire Laboratories' US Patent Nos. 6,322,819 ('the '819 Patent') and 6,605,300 ('the '300 Patent'). Watson Pharmaceuticals , Inc., the recent acquirer of Andrx, is also being named in the lawsuits.

The lawsuits result from an Abbreviated New Drug Application filed by Andrx for generic versions of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg Adderall XR®, pursuant to which Andrx provided notice that it would seek to market its generic products before the expiration of the '819 and '300 Patents in 2018. The lawsuits allege that all of Andrx's generic strengths infringe the patents in suit. Pursuant to Hatch-Waxman legislation, there will be a 30-month stay with respect to Andrx's proposed generic products.

Adderall XR is a Shire Attention Deficit Hyperactivity Disorder medicine.

Notes to Editors


Shire's strategic goal is to become the leading specialty pharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit and hyperactivity disorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) and renal diseases. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire believes that a carefully selected portfolio of products with a strategically aligned and relatively small-scale sales force will deliver strong results.

Shire's focused strategy is to develop and market products for specialty physicians. Shire's in-licensing, merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe.

For further information on Shire, please visit the Company's website:


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 of those on Shire's Attention Deficit and 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 dates of SPD503 (guanfacine extended release) (ADHD), SPD465 (extended release of mixed amphetamine salts) (ADHD), MESAVANCETM (mesalamine) with MMX technology (SPD476) (ulcerative colitis), ELAPRASETM (idursulfase) (Hunter Syndrome) and NRP104 (lisdexamfetamine dimesylate) (ADHD), including its scheduling classification by the Drug Enforcement Administration in the United States; Shire's ability to secure new products for commercialization and/or development; and other risks and uncertainties detailed from time to time in Shire's and its predecessor registrant Shire Pharmaceuticals Group plc's filings with the Securities and Exchange Commission, particularly Shire plc's Annual Report on Form 10-K for the year ended December 31, 2005.

Source: Shire plc

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