Sucampo Pharmaceuticals, announced that it, its affiliate Sucampo AG, R-Tech Ueno, Ltd., Takeda Pharmaceutical Company Limited (Takeda), and certain affiliates of Takeda have entered into a settlement and licence agreement with Anchen Pharmaceuticals, Inc., Par Pharmaceutical, Inc. and Par Pharmaceutical Companies, that resolves patent litigation in the United States (US) related to Sucampo’s Amitiza (lubiprostone) 8 mcg soft gelatin capsule and 24 mcg soft gelatin capsule.
Under the terms of the settlement, Sucampo and RTU will grant Par a non-exclusive licence to market Par’s generic version of lubiprostone 8 mcg soft gelatin capsule and 24 mcg soft gelatin capsule (licenced products) in the US for the indications approved for Amitiza beginning January 1, 2021, or earlier under certain circumstances. Beginning on January 1, 2021, Par will split with Sucampo the gross profits of the licenced products sold during the term of the agreement, which continues until each of the Sucampo patents has expired. In the event Par elects to launch an authorised generic, Sucampo will supply Par under the terms of a manufacturing and supply agreement at a negotiated price. Additional details of the agreement remain confidential.
Additionally, Sucampo, RTU, Takeda, and Par have agreed to dismiss with prejudice the patent litigation filed in the United States District Court for the District of Delaware.
Additionally, Sucampo said it has received a Paragraph IV certification notice letter (Notice Letter) regarding an Abbreviated New Drug Application (ANDA) submitted to the US Food and Drug Administration (US FDA) by Dr. Reddy’s Laboratories, Inc. (Dr. Reddy’s), requesting approval to market, sell and use a generic version of the 8 mcg and 24 mcg Amitiza (lubiprostone) soft gelatin capsule products. RTU has also received the ANDA letter from Dr. Reddy's.
Sucampo is currently reviewing the Notice Letter. By statute, if Sucampo initiates a patent infringement lawsuit against Dr. Reddy’s within 45 days of the Notice Date, the FDA would automatically stay approval of the Dr. Reddy’s ANDA until the earlier of 30 months from the notice date or entry of a district court decision finding the patents invalid or not infringed. The product is currently protected by 15 issued patents that are listed in the FDA's Orange Book, with the latest expiring in 2027.
The effects of this on the company’s operating results will be reported as they become clear.