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Wednesday, December 26, 2018

Neos Therapeutics Announces Settlement with Teva on Cotempla XR-ODT® Patent


Neos Therapeutics, Inc. (NEOS), a pharmaceutical company focused on developing, manufacturing, and commercializing innovative extended-release (XR) products using its proprietary modified-release drug delivery and orally disintegrating tablet (ODT) technology platforms, today announced that it has entered into a confidential settlement and licensing agreement with Teva Pharmaceuticals USA, Inc. (“Teva”) to resolve all ongoing litigation involving Neos’ patents protecting its Cotempla XR-ODT®(methylphenidate) extended-release orally disintegrating tablets and Teva’s Abbreviated New Drug Application (ANDA) filed with the U.S. Food and Drug Administration to market a generic version of that product.
Under the settlement and license agreement, Neos has granted Teva the right to manufacture and market its generic version of Cotempla XR-ODT® under the Teva ANDA beginning on July 1, 2026, or earlier under certain circumstances.
The settlement and licensing agreement is confidential and the agreement is subject to submission to the Federal Trade Commission and the U.S. Department of Justice.
“We are pleased to have reached this settlement and will continue to defend our innovative medicines against any challenge,” said Jerry McLaughlin, Chief Executive Officer of Neos Therapeutics.

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