Actelion Sues to Block Two Generics of Orphan Drug

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By Dana A. Elfin

Amneal Pharmaceuticals LLC and Zydus Pharmaceuticals (USA) Inc.'s proposed generic versions of the pulmonary arterial hypertension drug Opsumit infringe Actelion Pharmaceuticals Ltd.'s patent on the orphan drug, Actelion said.

In a suit filed Jan. 31 in the U.S. District Court for the District of New Jersey, Actelion asked the court to block the Food and Drug Administration from approving the generics until October 2022, when U.S. Patent No. 7,094,781 expires. Opsumit has orphan drug status, which means it gets special incentives including tax credits and an extra seven years of marketing exclusivity upon FDA approval.

Opsumit has produced strong results for Actelion despite the small patient population with PAH. In fact, specialty drugs for rare disorders often carry a significant price tag. For example, the out-of-pocket cost for Opsumit oral tablet 10 mg even with a drug discount card is more than $4,700 for just 15 tablets, according to the site

Opsumit is indicated to treat PAH to delay disease progression.

Actelion’s strong track record in PAH drugs was a big selling point for Johnson & Johnson, which is expected to close a deal to purchase Actelion in the second quarter. Access to Opsumit, along with Actelion’s drugs Tracleer and Uptravi, which also treat life-threatening PAH, will make J&J a leader in treating PAH and help it expand its disease portfolio beyond autoimmune, heart, and cancer drugs.

Orphan Drug

Orphan drugs treat rare diseases affecting fewer than 200,000 people in the U.S. Actelion holds the approved New Drug Application (NDA) for Opsumit (macitentan) 10 mg oral once-a-day tablets. The FDA granted Opsumit an additional seven years of exclusivity that expires Oct. 18, 2020.

The ‘781 patent is titled sulfamides and their use as endothelin receptor antagonists and is listed in the FDA’s Orange Book, a listing of patents branded drug companies claim cover their drug products.

Actelion is a Swiss corporation. Zydus, a subsidiary of Indian company Cadila Healthcare Ltd., is based in Pennington, N.J. Amneal is based in Bridgewater, N.J.

Paul Hastings LLP and Saul Ewing Arnstein & Lehr LLP represent Actelion.

The case is Actelion Pharmaceuticals Ltd. v. Zydus Pharmaceuticals (USA), Inc. , D.N.J., No. 3:18-cv-01397, complaint filed 1/31/18

To contact the reporter on this story: Dana A. Elfin in Washington at

To contact the editor responsible for this story: Brian Broderick at

For More Information

The lawsuit is at

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