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news.Antares Pharma announced that Teva Pharmaceuticals USA, Inc. has settled the patent litigation with AstraZeneca Pharmaceuticals LP, AstraZeneca AB and Amylin Pharmaceuticals, LLC (AstraZeneca) relating to AstraZeneca’s US Patent Nos. 6,858,576, 6,872,700, 6,956,026, 7,297,761, 6,902,744, 7,521,423, and 7,741,269 and AstraZeneca’s BYETTA® (exenatide).
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It also entered into a settlement and license agreement with AstraZeneca, pursuant to which AstraZeneca granted a license to Teva to manufacture and commercialize the generic version of BYETTA® described in Teva’s ANDA No. 205984 in the United States.
According to Teva, the settlement allows them to commercialize its generic version of BYETTA® (exenatide injection) in the U.S. beginning October 15, 2017 or earlier under certain circumstances. All other terms of the agreement are confidential.
"We are very pleased that Teva was able to settle the patent dispute on this important product and we look forward to supporting Teva in the approval and launch of generic BYETTA," said Robert Apple, President and Chief Executive Officer of Antares Pharma. "We are now one step closer to potentially commercializing this important product for patients with type 2 diabetes."
BYETTA® (exenatide injection) is an injectable product used to treat type 2 diabetes. Under an exclusive license agreement, Antares Pharma supplies the multi-dose pen that Teva will use to commercialize their generic version of BYETTA®, which is currently under review at the U.S. Food and Drug Administration.
Antares believes that Teva may be the "first applicant" to file an ANDA for a generic equivalent of BYETTA® and, should Teva’s ANDA be approved, may be entitled to 180 days of generic market exclusivity.
Antares Pharma focuses on self-administered parenteral pharmaceutical products. The Company’s product, OTREXUP™ (methotrexate) injection for subcutaneous use, is approved in the U.S. for the treatment of adults with severe active rheumatoid arthritis, children with active polyarticular juvenile idiopathic arthritis and adults with severe recalcitrant psoriasis.
Antares Pharma is also developing QuickShot® Testosterone for testosterone replacement therapy, and has recently received a therapeutically equivalent approval from the U.S. Food and Drug Administration for VIBEX® Sumatriptan USP for the acute treatment of migraine and cluster headache.