Neos Therapeutics, Teva Settle on Patent Litigation for ADHD Drug

December 26, 2018
Pharmaceutical Technology Editors

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.

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