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Shire grabs Par’s attention with patent lawsuit

Generics/News | Posted 03/04/2015 0 Post your comment

Shire has served its rival Par Pharmaceutical (Par) with a patent infringement lawsuit in New Jersey Federal Court over Par's application to market a generic version of Shire's attention deficit hyperactivity disorder medication Adderall XR.

Shire holds two patents related to the drug, ’096 and ‘148 (both for ‘Oral Pulsed Dose Drug Delivery System’). The company wants to withhold generic Adderall XR (amphetamine, dextroamphetamine mixed salt) approval until the two patents expire in April 2019.

Shire has lost similar battles in the past, with the US Food and Drug Administration approving an Adderall XR generic from Actavis in 2012 [1].

At the time, Shire, UK’s third largest pharmaceutical company; believed that it would remain competitive in the Adderall XR marketplace through the distribution of branded XR and through its two authorized generic partners, Teva and Impax. Israel’s Teva and US-based Impax laboratories produced authorized generics of Adderall XR.

At the end of 2013, an agreement was reached between Shire and Sandoz, the generics division of Novartis, giving exclusive rights to Sandoz to sell an authorized generic version of Adderall XR supplied by Shire as of 1 July 2016 [2]. The agreement between the two companies will reportedly run for five years from the effective date of 1 December 2013.

References
1. GaBI Online - Generics and Biosimilars Initiative. Generic Adderall XR approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Apr 3]. Available from: www.gabionline.net/Generics/News/Generic-Adderall-XR-approved-in-the-US
2. GaBI Online - Generics and Biosimilars Initiative. Sandoz makes deal with Shire for authorized Adderall XR generic [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Apr 3]. Available from: www.gabionline.net/Generics/News/Sandoz-makes-deal-with-Shire-for-authorized-Adderall-XR-generic

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