Sucampo Pharmaceuticals today announced that Sucampo, R-Tech Ueno, Ltd., Takeda Pharmaceutical Company Limited, and certain affiliates of Takeda have filed a patent infringement lawsuit in the United States District Court for the District of New Jersey against Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively, Dr. Reddy’s) related to an Abbreviated New Drug Application (ANDA) that Dr. Reddy’s filed with the U.S. Food and Drug Administration (FDA) to market, sell and use a generic version of the 8 mcg and 24 mcg AMITIZA(R) (lubiprostone) soft gelatin capsule products. The lawsuit claims infringement of 7 patents that are listed in the FDA’s Orange Book, with the latest expiring in 2027.

Sucampo commenced the lawsuit within 45 days from the receipt of a Notice letter sent by Dr. Reddy’s, dated October 1, 2014, regarding its filing of its ANDA. Under the Hatch-Waxman Act, as a result of the patent infringement lawsuit, final FDA approval of Dr. Reddy’s ANDA will be stayed up to 30 months from the date of receipt of the Notice letter.

“Protecting AMITIZA’s intellectual property is of paramount importance to Sucampo,” said Peter Greenleaf, Chief Executive Officer of Sucampo.
“We believe that the AMITIZA patents, granted by the U.S. Patent & Trademark Office, are valid, enforceable, and infringed by Dr. Reddy’s proposed lubiprostone products, and we will vigorously defend them.”