Esperion announced that it has entered into a settlement agreement with Dr. Reddy’s Laboratories, Inc. and its affiliate Dr. Reddy’s Laboratories Ltd. (together, Dr. Reddy’s Laboratories). This agreement resolves the patent litigation brought by Esperion against Dr. Reddy’s Laboratories in response to Dr. Reddy’s Laboratories’ Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of each of NEXLETOL and NEXLIZET prior to the expiration of the applicable patents. Pursuant to the agreement, Dr. Reddy’s Laboratories has agreed not to market a generic version of either NEXLETOL or NEXLIZET in the United States prior to April 19, 2040, unless certain limited circumstances customarily included in these types of agreements occur.

As previously disclosed, Esperion reached settlement agreements with Micro Labs USA, Inc. and its affiliate; Hetero USA Inc. and its affiliates; and Accord Healthcare Inc. earlier this year with respect to their generic versions of NEXLETOL. Bempedoic acid is claimed in Esperion’s U.S Patent No. 7,335,799, which is scheduled to expire in December 2030. With this latest settlement with Dr. Reddy’s Laboratories, there are no remaining challenges regarding the validity or infringement of U.S Patent No. 7,335,799 in the pending patent litigation. Certain of Esperion’s patents that remain subject to the pending patent litigation are scheduled to expire in March 2036, while others are scheduled to expire in June 2040.

The pending patent litigation against the remaining defendants (Alkem Laboratories Ltd.; Aurobindo Pharma Limited (along with an affiliate); MSN Pharmaceuticals Inc. (along with an affiliate); Renata Limited (along with an affiliate); and Sandoz Inc.) is ongoing, and there can be no assurance whether such ongoing patent litigation will allow a generic version of NEXLETOL and/or NEXLIZET, as applicable, to be marketed in the U.S. prior to April 19, 2040.