Teva Pharmaceutical USA Inc. and Mylan Pharmaceuticals Inc. notched a win that may have moved them closer to launching generic versions of Allergan Plc’s ulcer treatment Delzicol.
The U.S. Court of Appeals for the Federal Circuit affirmed without opinion a district court ruling finding Mylan and Teva’s proposed generics didn’t infringe Allergan’s patent. Delzicol treats mild to moderately active ulcerative colitis. According to Symphony Health data reported by Bloomberg Intelligence, the drug had sales of approximately $273. 2 million in 2017.
The generic makers still have to obtain final Food and Drug Administration approval for their products before they can launch. But when they launch, it’s likely generic versions will substantially eat into sales of the branded drug.
Elizabeth DeLuca, senior director of corporate communications at Teva, didn’t disclose launch plans for the generic but told Bloomberg Law Dec. 12 the company was pleased with the ruling and looks forward to supporting patients with generic medicines “when we are otherwise able to.”
Allergan has settled patent litigation with other companies that filed applications to make generic versions of the drug.
In December 2016, the Dublin-based company settled litigation with Zydus Pharmaceuticals (USA) Inc., and Cadila Healthcare Ltd. that would allow them to market a generic version of Delzicol beginning on March 1, 2020, or earlier under certain circumstances.
Bloomberg Law reached out to Mylan and Allergan for comment but no one from either company was available to respond.
Covington & Burling LLP represented Allergan and Warner Chilcott (now part of Allergan). Sterne Kessler Goldstein & Fox PLLC represented Teva.
The case is Warner Chilcott (US) LLC v. Teva Pharmaceuticals USA Inc., Fed. Cir., No. 2018-01241, nonprecedential 12/12/18.
To contact the reporter on this story: