Shire brings legal suit against Corepharma.
Shire plc Shire plc (LSE: SHP) is a British manufacturer of pharmaceuticals including Adderall XR, Carbatrol, and Fosrenol. It was founded in 1986. Corporate strategy (Basingstoke, England) announced that its subsidiary Shire Laboratories Inc. has filed a lawsuit in the United States District Court for the District of New Jersey The United States District Court for the District of New Jersey is the Federal district court whose jurisdiction is the state of New Jersey. It was established in 1789. New Jersey is the largest state by population to only have one District Court.
The Honorable Garrett E. against Corepharma LLC (Logical Link Control) See "LANs" under data link protocol.
LLC - Logical Link Control ("Corepharma") for infringement of Shire Laboratories' United States Patents 5,326,570 ("'570 Patent ") and 5,912,013 ("'013 Patent ").
The lawsuit results from an Abbreviated New Drug Application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar ("ANDA ANDA
abbreviated new drug application ") filed by Corepharma for generic versions of Shire's 100 mg, 200 mg, and 300 mg CARBATROL products, as to which Corepharma provided notice to Shire that it is seeking FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. approval to market its generic products prior to the expiration of the '570 and '013 Patents. Pursuant to Hatch-Waxman legislation, the lawsuit triggers a stay of FDA approval of up to 30 months from Corepharma's notice to allow the court to resolve the suit.
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 central nervous system, gastrointestinal, general products and human genetic therapies. 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.