Shire brings legal suit against Corepharma.
The lawsuit results from an Abbreviated New Drug Application ("ANDA") 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 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.
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|Publication:||BIOTECH Patent News|
|Date:||May 1, 2006|
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