By Sherri Oslick —

As reported here, on August 9, Eli Lilly filed suit in the District Court of New Jersey against Actavis Elizabeth in answer to Actavis’ filing of an ANDA (and concomitant Paragraph IV certification) to manufacture a generic version of Lilly’s Strattera®. Earlier this month, Lilly filed an amended complaint in the case, adding additional ANDA/Paragraph IV filers Glenmark Pharmaceuticals, Sun Pharmaceuticals, Sandoz, Mylan Pharmaceuticals, Apotex, Aurobindo Pharma, Teva Pharmaceuticals, Synthon Laboratories, and Zydus Pharmaceuticals. Sandoz, as reported here, had previously filed suit against Lilly seeking declaratory judgment of non-infringement and invalidity of the patent at issue.

Strattera®, or atomoxetine hydrochloride, a norepinephrine reuptake inhibitor, is a non-stimulant medication used in the treatment of Attention-Deficit/ Hyperactivity Disorder (ADHD) in children, adolescents, and adults. The method of treatment is covered by U.S. Patent No. 5,658,590 ("Treatment of Attention-Deficit/ Hyperactivity Disorder," issued August 19, 1997). The ‘590 patent is set to expire on May 26, 2017.

Leave a comment