Neos Therapeutics, a specialty pharmaceutical company with a portfolio of novel and proprietary oral drug delivery technologies as well as a late-stage pipeline of innovative extended release (XR) products for Attention Deficit Hyperactivity Disorder (ADHD), has settled all pending litigation with Shire LLC (Shire) in connection with Neos’ amphetamine polistirex orally disintegrating tablet known as NT-0202 for the treatment of ADHD. NT-0202 is positioned to be the first-ever, extended release orally disintegrating tablet (XR-ODT) dosage form of amphetamine for the treatment of ADHD.
The litigation involved a patent infringement lawsuit brought by Shire under the Hatch-Waxman Act framework stemming from Neos’s filing of its New Drug Application under section 505(b)(2) of the Federal Food, Drug, and Cosmetics Act for NT-0202 with the United States Food and Drug Administration (“US FDA”). On April 11, 2013, Shire filed suit against Neos asserting that Neos infringed US Patent No. RE 42,096 and US Patent No. 41,148 (collectively, the “Patents”).
The parties have entered into a Licence Agreement which provides Neos with a licence to the Patents and US Patent No. 6,913,768, to make, market and sell NT-0202. Neos will pay Shire a royalty from the sales of NT-0202 until the expiration of the patents.
Vipin K. Garg, Ph.D., president and chief executive officer, of Neos, stated, “We are very pleased to have reached this settlement with Shire. Neos will continue to pursue FDA approval of NT-0202 without further risk of delay due to this litigation.”