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Shire fights to keep Adderall XR patent
By Lisa Kerner
Erie, Pa., Jan. 18 - Shire plc said it will continue to protect its patent on Adderall XR, an important product in Shire's portfolio of treatments for attention deficit/hyperactivity disorder.
Adderall is protected by two patents which expire in 2018:
Shire received a third Paragraph IV notice letter from Teva Pharmaceuticals USA, Inc. advising it of an amendment to Teva's existing Abbreviated New Drug Application for generic versions of Adderall XR, according to a company news release.
The amendment is directed to an additional strength of 25 mg. Teva's February 2005 Paragraph IV notice letter was directed only to 10 mg and 30 mg dosages, while Teva's June 2005 Paragraph IV notice letter was directed only to 5 mg, 15 mg and 20 mg dosages.
Shire is currently reviewing the details of Teva's latest Paragraph IV notice letter.
Shire and Impax Laboratories, Inc. said the U.S. District Court of the District of Delaware has granted the parties' request to extend until Jan. 26 the deadline for the parties to submit their pretrial order. The court also agreed to stay the matters of the case pending settlement negotiations.
The case is a patent infringement lawsuit involving two of Shire's U.S. patents and Impax's attempt to market a generic version of Shire's Adderall XR prior to the expiration of those patents.
Shire is a specialty pharmaceutical company focused on central nervous system, gastrointestinal, and human genetic therapies. The company is based in Basingstoke, England.
Phildadelphia-based Teva Pharmaceuticals USA manufactures and markets generic drugs.
Impax Laboratories is a technology based specialty pharmaceutical specializing in the development of controlled-release products.
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