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Essapp宣布已与第三个简化新药申请文件提交人达成和解协议,在2040年4月19日之前不销售NEXLETOL的通用版本

2025-07-08 20:08

Esperion (NASDAQ:ESPR) today announced that it has entered into a settlement agreement with Accord Healthcare Inc. This agreement resolves the patent litigation brought by Esperion against Accord Healthcare Inc. in response to Accord Healthcare Inc's Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of NEXLETOL prior to the expiration of the applicable patents. Pursuant to the agreement, Accord Healthcare Inc. has agreed not to market a generic version of NEXLETOL in the United States prior to April 19, 2040, unless certain limited circumstances customarily included in these types of agreements occur.

The pending patent litigation against the remaining defendants (Alkem Laboratories Ltd.; Aurobindo Pharma Limited (along with an affiliate); Dr. Reddy's Laboratories Inc. (along with an affiliate); MSN Pharmaceuticals Inc. (along with an affiliate); Renata Limited; 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.

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