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Sepracor and Teva resolve patent infringement litigation

Sepracor, a research-based pharmaceutical company, has entered into a settlement and licensing agreement with Teva Pharmaceuticals USA, and Barr Laboratories, a wholly owned subsidiary of Teva, to resolve the patent litigation against Barr involving Sepracor's Xopenex brand levalbuterol HCl inhalation solution products and to grant a license to Barr and Teva.

The agreement permits Barr and Teva to launch generic versions of these Xopenex inhalation solution dosages under terms of a non-exclusive license commencing on February 17, 2013. The agreement also contains provisions whereby the effective date of Barr’s and Teva’s license can be earlier under certain circumstances.

Upon launch, Teva and Barr will pay Sepracor a royalty on their respective profit margins generated from the sales of generic versions of these Xopenex inhalation solution dosages. The parties agreed to promptly file a consent final judgment and dismissal in the US District Court of Delaware that will conclude this litigation.

The settlement agreement is believed to be a final settlement of the Barr litigation. The settlement with Barr does not end all disputes related to generic Xopenex inhalation solution products, as litigation against Dey, remains pending. In compliance with US law, the settlement and licensing agreement will be submitted to the US Federal Trade Commission and Department of Justice and are subject to review.

Adrian Adams, president and CEO of Sepracor, said: “We are very pleased with the resolution of our patent infringement dispute with Barr and patent issues with Teva as it allows all parties to avoid the uncertainties and expenses related to patent litigation. With the lawsuit and these patent issues behind us, Sepracor can continue to focus on fully leveraging each of our product franchises and advancing our R&D candidates.”