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news.Shire and Barr Laboratories have come to an agreement to settle all pending litigation over the latter's proposed generic version of Shire's Adderall XR, an extended release treatment for attention deficit hyperactivity disorder.
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The companies have also entered into a separate deal concerning certain women’s health products.
Under the Adderall XR agreement Barr will not be allowed to market its generic version of the product until April 1, 2009, except for certain limited circumstances, such as the launch of another party’s generic version of Adderall XR.
As part of the settlement, Barr agreed to permanent injunctions confirming the validity and enforceability of certain patents which Shire holds on the ADHD medication.
Shire previously came to an agreement with Impax Laboratories which allows Impax to market a generic version of Adderall XR 181 days following Barr’s launch.
Additionally, Duramed, a subsidiary of Barr, has agreed to purchase Shire’s immediate release version of Adderall for $63 million. This transaction is subject to reporting under the US Hart-Scott-Rodino Act.
Shire and Duramed have also entered into a separate agreement related to Duramed’s transvaginal ring technology that will be applied to at least five women’s health products, as well as a license to Duramed’s currently marketed oral contraceptive, Seasonique.
Under this agreement, Shire will make an initial payment of $25 million to Duramed for previously incurred product development expenses, and will reimburse Duramed for development expenses up to a maximum of $140 million over eight years.
“We are very pleased to have reached this settlement on terms that are consistent with our beliefs that Shire’s patents are valid and enforceable and infringed by would-be generic competitors. We are also excited about the opportunity of a new development and licensing agreement in the specialty area of women’s health, particularly in Europe,” said Matthew Emmens, Shire’s CEO.