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Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) announced that it has reached settlements with Sandoz, Actavis, Lupin and Apotex with respect to U.S. 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 (ES) due to obstructive sleep apnea (OSA), shift work disorder (SWD), or narcolepsy.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world's leading generic drug maker, with a global product portfolio of more than 1,000 molecules and a direct presence in approximately 60 countries. Teva's Specialty Medicines businesses focus on CNS, respiratory, oncology, pain, and women's health therapeutic areas as well as biologics. Teva currently employs approximately 45,000 people around the world and reached $20.3 billion in net revenues in 2013.