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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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Nexlizet (2023)

Total Spending

$46.9M

Total Claims

63,623

Beneficiaries

16,678

Avg Cost/Unit

$13.77

Spending Trend

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

YoY Change:+3.9%

5yr CAGR:+7.8%

Source: CMS Medicare Part D Spending by Drug (2023). 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)

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