Neos Therapeutics, Teva Settle on Patent Litigation for ADHD Drug

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Teva Pharmaceuticals and Neos Therapeutics entered into a settlement and licensing agreement to resolve all ongoing litigation involving Neos' patents protecting its Cotempla (methylphenidate) extended-release orally disintegrating tablets.

Neos Therapeutics, a pharmaceutical company focused on developing, manufacturing, and commercializing extended-release (XR) products using its proprietary modified-release drug delivery and orally disintegrating tablet (ODT) technology platforms, announced on Dec. 26, 2018 that it has entered into a confidential settlement and licensing agreement with Teva Pharmaceuticals USA 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 FDA 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.

Cotempla XR-ODT is used to treat ADHD in patients 6 to 17 years of age. Neos states that the technology behind this orally disintegrating tablet uses two different types of drug micro-particles. The first type of micro-particle immediately releases up to 25% of the medication once taken by the patient. The second type of micro-particle slowly releases the other 75% of the medication throughout the day.

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The settlement and licensing agreement is confidential and the agreement is subject to submission to the Federal Trade Commission and the US Department of Justice.

Source: Neos Therapeutics