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Licensing In Brief

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Impax to promote Shire's Carbatrol: Impax will kick-start its brand pharmaceutical business by promoting Shire's epilepsy treatment Carbatrol (carbamazepine extended-release) in the U.S., beginning in July, under a Jan. 19 agreement. Announced in conjunction with settlement of the firms' Adderall XR patent suit, the Carbatrol pact calls for Impax to detail the latter agent in the U.S. for three years. The "general framework of the [Carbatrol] agreement calls for Impax to receive approximately $40 mil." plus performance-based incentives based on prescription growth, Impax says. Impax expects Carbatrol to help the firm achieve promotion synergies in the central nervous system field as it awaits FDA approval sometime this year for its Vadova (carbidopa/levodopa) Parkinson's treatment. The Adderall XR (amphetamine salts) settlement allows Impax to bring a generic of the Shire attention-deficit hyperactivity disorder drug to market by at least 2010 - almost a decade before expiration of exclusivity. Shire remains in litigation with Barr, which also has filed an ANDA for generic Adderall XR. No trial date has yet been set for Shire's suit against Barr. Teva and Colony also have filed ANDAs for generic Adderall XR, but Shire has not announced plans to sue...

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