Is Esperion Therapeutics, Inc. FDA approved?

Esperion Therapeutics, Inc. holds no registered establishment of its own; 2 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Esperion Therapeutics, Inc. make?

2 products are listed under Esperion Therapeutics, Inc. in the openFDA NDC Directory, most often as tablet, film coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Esperion Therapeutics, Inc.

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 0
Active NDC listings: 2
Live patents: 15
Exclusivities: 2
Countries: 0

Catalogue

Drug listings by form and route

2 active NDC listings: 2 human prescription drug. By marketing category: NDA 2.

Dosage form	NDCs
tablet, film coated	2

Route	NDCs
oral	2

Labeller name on the listing	NDCs
esperion therapeutics, inc.	2

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
7335799	NEXLETOL, NEXLIZETbempedoic acid; bempedoic acid; ezetimibe	substance	Dec 2030
10912751	NEXLIZETbempedoic acid; ezetimibe	use	Mar 2036
11744816	NEXLETOL, NEXLIZETbempedoic acid; bempedoic acid; ezetimibe	use	Mar 2036
11613511	NEXLETOL, NEXLIZETbempedoic acid; bempedoic acid; ezetimibe	substance	Jun 2040
11760714	NEXLETOL, NEXLIZETbempedoic acid; bempedoic acid; ezetimibe	product	Jun 2040
11926584	NEXLETOL, NEXLIZETbempedoic acid; bempedoic acid; ezetimibe	use	Jun 2040
12398087	NEXLETOL, NEXLIZETbempedoic acid; bempedoic acid; ezetimibe	substance, product	Jun 2040
12404227	NEXLETOL, NEXLIZETbempedoic acid; bempedoic acid; ezetimibe	substance	Jun 2040

Product	Exclusivity	Until
NEXLETOLBEMPEDOIC ACID	I-943 New indication	Mar 2027
NEXLIZETBEMPEDOIC ACID; EZETIMIBE	I-943 New indication	Mar 2027

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Nexletol	Bempedoic Acid	tablet, film coated, oral	72426-118NDA
Nexlizet	Bempedoic Acid and Ezetimibe	tablet, film coated, oral	72426-818NDA

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Enquiry

Common questions

Is Esperion Therapeutics, Inc. FDA approved?: Esperion Therapeutics, Inc. holds no registered establishment of its own; 2 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Esperion Therapeutics, Inc. make?: 2 products are listed under Esperion Therapeutics, Inc. in the openFDA NDC Directory, most often as tablet, film coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.