Generic Restasis plans revealed days after patent invalidation

A San Diego-based company has announced plans to sell a generic version of Allergan’s dry eye disease treatment Restasis (cyclosporine ophthalmic emulsion), just days after four patents covering the drug were invalidated.

In an announcement on Thursday, October 19, Imprimis Pharmaceuticals said it would make cyclosporine-based formulations available for physicians to consider prescribing as “customisable and potentially lower-cost alternatives to Restasis”.

Three days before the announcement, four Allergan-owned patents covering the drug were invalidated at the US District Court for the Eastern District of Texas.

That case was one of two sets of challenges to the drug, with inter partes reviews (IPRs) also pending at the US Patent and Trademark Office.

The district court’s judgment, handed down by Judge William Bryson, criticised Allergan’s decision to transfer the patents on the drug to the Saint Regis Mohawk Tribe.

The tribe has sovereign immunity and said this protects the patents from being reviewed under the IPR.

Bryson said the court “has serious concerns about the legitimacy of the tactic” which, he said, allows Allergan to purchase—or rent—the tribe’s sovereign immunity to defeat the pending IPR proceedings.

Although drug makers Mylan, Teva and Akorn were the challengers in the court case, Imprimis is so far the only pharma company to formally announce generic intentions.

Dry eye disease, which causes irritated, gritty, scratchy or burning eyes and blurred vision, is estimated to affect up to 30 million Americans.

Mark Baum, CEO of Imprimis, said topical cyclosporine—“an off-patent and inexpensive drug”—can cost more than $5,000 per year when it is purchased in Allergan’s commercially available form, Restasis.

“We believe that affordability can affect access to needed medications, and it is our hope that our formulations will allow more patients to gain access to a high quality customised cyclosporine treatment option,” Baum said.

Did you enjoy reading this story?  Sign up to our free newsletters and get stories like this sent straight to your inbox.