Viewing data from:

NEXLIZET

NDA

BEMPEDOIC ACID; EZETIMIBE | N211617 | ESPERION THERAPEUTICS INC

1 strength8 unique patents2 unique exclusivities

Patent Timeline

8 unique patents, 2 exclusivities by expiration date

Active (8)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

Today

Dec. 3, 2030

Mar. 14, 2036

Jun. 19, 2040

Mar. 14, 2036

Jun. 19, 2040

Jun. 19, 2040

Jun. 19, 2040

Jun. 19, 2040

I-943

Mar. 22, 2027

I-945

Mar. 22, 2027

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

4 cases on OB patents (3 active) from PACER

Case	Court	Filed	Status	Judge
ESPERION THERAPEUTICS, INC. v. RENATA LIMITED et al 2:2026cv02326 7 patentsANDA 221169bempedoic acid and ezetimibe	D.N.J.	2026-03-05	Active	—
ESPERION THERAPEUTICS, INC. v. SANDOZ INC. 2:2024cv06387 5 patentsANDA 219347, 219346Bempedoic acid; Bempedoic acid and Ezetimibe	D.N.J.	2024-05-23	Active	—
ESPERION THERAPEUTICS, INC. v. DR. REDDY'S LABORATORIES INC. et al 2:2024cv06391 6 patentsANDA 219312, 219331bempedoic acid; bempedoic acid and ezetimibe	D.N.J.	2024-05-23	Active	—
ESPERION THERAPEUTICS, INC. v. ALKEM LABORATORIES LTD. 2:2024cv06263 4 patentsANDA 219416, 219421Bempedoic acid; Bempedoic acid and Ezetimibe	D.N.J.	2024-05-17	Terminated 2026-02-18	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

2 trials from ClinicalTrials.gov, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Bempedoic Acid + Ezetimibe Fixed-Dose Combination (FDC) Study in Patients With Type 2 Diabetes and Elevated LDL-C NCT03531905	Phase 2	Completed	Esperion Therapeutics, Inc.	242	2018-05-09 → 2019-06-18
A Study Evaluating the Safety and Efficacy of Bempedoic Acid Plus Ezetimibe Fixed-Dose Combination Compared to Bempedoic Acid, Ezetimibe, and Placebo in Patients Treated With Maximally Tolerated Statin Therapy NCT03337308	Phase 3	Completed	Esperion Therapeutics, Inc.	382	2017-10-23 → 2018-07-18

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$13.82

per ea

Lowest NADAC/Unit

$13.82

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
72426081803NEXLIZET 180-10 MG TABLET	$13.82	EA	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$312.61

Highest Price

$384.43

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
72426-0818-03NEXLIZET	$384.43	FSS	Esperion Therapeutics	04/14/2026
72426-0818-03NEXLIZET	$312.61	Big4	Esperion Therapeutics	04/14/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Nexlizet (2024)

Total Spending

$70.8M

Total Claims

97,223

Beneficiaries

27,149

Avg Cost/Unit

$13.07

Spending Trend

$1.7M(2020)→$15.3M(2021)→$30.5M(2022)→$46.9M(2023)→$70.8M(2024)

YoY Change:-5.1%

5yr CAGR:+4.4%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Jan 16, 2026	SUPPL -31	View Letter (PDF)
Nov 24, 2025	SUPPL -29	View Letter (PDF)
Jul 22, 2025	SUPPL -28	View Letter (PDF)
Jul 22, 2025	SUPPL -27	View Letter (PDF)
Mar 25, 2024	SUPPL -17	View Letter (PDF)
Mar 25, 2024	SUPPL -16	View Letter (PDF)
Dec 14, 2023	SUPPL -19	View Letter (PDF)
Sep 21, 2023	SUPPL -18	View Letter (PDF)
Feb 27, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 180MG;10MG

RLD

8 patents2 exclusivities▴

TABLET;ORAL | Approved: Feb 26, 2020

Patents (8) · 6 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7335799	Dec 3, 2030	—	Yes	—	—	—
10912751	Mar 14, 2036	—	—	—		—
11613511	Jun 19, 2040	—	Yes	—	—	—
11744816	Mar 14, 2036	—	—	—		—
11760714	Jun 19, 2040	—	—	Yes	—	—
11926584	Jun 19, 2040	—	—	—		—
12398087	Jun 19, 2040	—	Yes	Yes	—	—
12404227	Jun 19, 2040	—	Yes	—		—

Exclusivities (2)

Code	Date	Status
I-943	Mar 22, 2027	< 1 year
I-945	Mar 22, 2027	< 1 year