US generics manufacturer, Mylan Laboratories, was celebrating yesterday after winning the US Food and Drug Administration green light to market its copyat version of Johnson & Johnson’s chronic pain patch, Duragesic (fentanyl transdermal system).
Mylan’s version of the product, which the company says it will begin shipping immediately, had a long route to market after the FDA rescinded original approval after a court ruled that Mylan’s product infringed J&J patents [[24/06/04d]]. The latter company was then awarded an additional six months of marketing exclusivity.