US commercial stage biopharmaceutical company Esperion Therapeutics Inc (NASDAQ:ESPR) on Friday announced a settlement with Indian pharmaceutical company Dr. Reddy's Laboratories Ltd (BSE:500124, NSE:DRREDDY, NYSE:RDY, NSEIFSC:DRREDDY) and its affiliate, resolving patent litigation over generic versions of NEXLETOL (bempedoic acid) and NEXLIZET (bempedoic acid and ezetimibe).
Under the agreement, Dr. Reddy's Laboratories will not market generics of either product in the United States before 19 April 2040, except under limited, customary circumstances.
This settlement follows earlier agreements with Micro Labs USA Inc, Hetero USA Inc, and Accord Healthcare Inc regarding NEXLETOL generics. Esperion's US Patent No. 7,335,799 for bempedoic acid is set to expire in December 2030, and the latest settlement eliminates remaining challenges to this patent. Additional Esperion patents relevant to the litigation expire in March 2036 and June 2040.
Ongoing patent disputes involve Alkem Laboratories Ltd, Aurobindo Pharma Limited and its affiliate, MSN Pharmaceuticals Inc and its affiliate, Renata Limited and its affiliate, and Sandoz Inc, with outcomes current;y uncertain regarding potential early generic entry.
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