Sucampo hits Dr. Reddy’s with Amitiza lawsuit

US pharmaceutical company Sucampo Pharmaceuticals has sued India-based Dr. Reddy’s Laboratories, asserting patents covering its constipation treatment Amitiza (lubiprostone).

The lawsuit, filed at the US District Court for the District of New Jersey, is in response to an Abbreviated New Drug Application (ANDA) submitted by Dr. Reddy’s at the US Food and Drug Administration (FDA).

In a statement, Sucampo and Takeda Pharmaceuticals, with which it has a licensing deal for Amitiza, said the application by Dr. Reddy’s would infringe the claims of seven patents, the latest of which expires in 2027.

Dr. Reddy’s sought permission to “market, sell and use” a generic version of the 8 mcg and 24 mcg Amitiza soft gelatin capsules, Sucampo said.

Sucampo said it filed the lawsuit within 45 days of the receipt of a notice letter sent by Dr. Reddy’s on October 1 that outlined its ANDA filing.

Peter Greenleaf, chief executive of Sucampo, said protecting the IP for Amitiza was of “paramount importance” to Sucampo.

“We believe that the patents, granted by the US Patent and Trademark Office, are valid, enforceable, and infringed by Dr. Reddy’s proposed lubiprostone products, and we will vigorously defend them,” he added.

Dr. Reddy’s did not respond immediately to a request for comment.