Esperion files Hatch-Waxman patent suit against Micro Labs over generic NEXLETOL

Esperion Therapeutics, Inc.

Filed May 8, 2024 in District of New Jersey against Micro Labs USA Inc. for NEXLETOL generic ANDA.
Nine ANDA filers sent Paragraph IV certifications; lawsuit triggered 30-month FDA approval stay.
Esperion intends to file similar suits against remaining eight ANDA filers for NEXLETOL and NEXLIZET.
Complaint seeks injunction barring FDA approval and permanent injunction until patent expiration.
Litigation covers Orange-listed patents; company vows to vigorously defend IP.

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