Teva Settles Nuvigil Patent Litigation

Teva Pharmaceutical Industries Ltd. has reached settlements with Sandoz, Actavis, Lupin, and Apotex with respect to U. Patent 7,132,570 (the “570 patent”) for Teva's wakefulness product, Nuvigil (armodafinil) tablets. These settlements dismiss a pending appeal with the United States Court of Appeals for the Federal Circuit of a trial court decision that found the ‘570 patent to be valid and infringed.

Teva has reached settlements with each of these companies, granting licenses to allow these parties to market their generic products 180 days after Mylan, the first generic company to file an abbreviated new drug application (ANDA) for the 50-mg, 150-mg, and 250-mg dosages of Nuvigil. The settlements allow Actavis to launch generic 100-mg and 200-mg dosages in June 2016, and the others may launch these dosages 180 days after Actavis in the 100-mg and 200-mg dosage forms. Additional terms of the settlements are agreed by the parties to remain undisclosed.

Previously, Teva settled its patent infringement litigation regarding the ‘570 patent against Mylan, which allowed Mylan to begin selling generic versions of 50-mg, 150-mg, and 250-mg Nuvigil under license beginning in June 2016, or earlier under certain circumstances.

Nuvigil is a prescription medicine indicated to improve wakefulness in adults who experience excessive sleepiness due to obstructive sleep apnea, shift work disorder, or narcolepsy.

Source: Teva Pharmaceutical Industries

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