Mylan NV said the U.S. Food and Drug Administration has approved its generic version of Eli Lilly and Co.'s Adcirca, a treatment for high blood pressure to improve exercise ability.
The Canonsburg, Pa.-based generic-drug maker has launched tadalafil in 20-milligram tablets in the U.S., the first generic version of Adcirca. The FDA awarded Mylan 180 days of marketing exclusivity for the drug. Mylan said U.S. sales of tadalafil 20-milligram tablets were about $510 million for the 12 months ending May 31, citing data from IQVIA Holdings Inc.
Lilly's patent for Adcirca expired in May, following a pediatric exclusivity extension granted by the FDA to allow the company time to investigate the use of the drug in children with Duchenne muscular dystrophy, a genetic disorder that causes muscle degeneration and weakness.