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Mylan launches generic version of Lilly's Adcirca following US FDA nod

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.