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NEXLETOL

NDA

BEMPEDOIC ACID | N211616 | ESPERION THERAPEUTICS INC

1 strength7 unique patents2 unique exclusivities

Patent Timeline

7 unique patents, 2 exclusivities by expiration date

Active (7)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

Today

Dec. 3, 2030

Jun. 19, 2040

Mar. 14, 2036

Jun. 19, 2040

Jun. 19, 2040

Jun. 19, 2040

Jun. 19, 2040

I-943

Mar. 22, 2027

I-944

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

7 cases on OB patents (5 active) from PACER

Case	Court	Filed	Status	Judge
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. SANDOZ INC. 2:2024cv06387 5 patentsANDA 219347, 219346Bempedoic acid; Bempedoic acid and Ezetimibe	D.N.J.	2024-05-23	Active	—
ESPERION THERAPEUTICS, INC. v. AUROBINDO PHARMA LIMITED et al 2:2024cv06348 2 patentsANDA 219349bempedoic acid	D.N.J.	2024-05-22	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	—
ESPERION THERAPEUTICS, INC. v. ACCORD HEALTHCARE INC. 2:2024cv06224 3 patentsANDA 219430bempedoic acid	D.N.J.	2024-05-16	Terminated 2025-07-14	—
ESPERION THERAPEUTICS, INC. v. RENATA LIMITED 2:2024cv06017 2 patentsANDA 219257bempedoic acid	D.N.J.	2024-05-10	Active	—
ESPERION THERAPEUTICS, INC. v. MICRO LABS USA, INC. et al 2:2024cv05921 2 patentsANDA 219182bempedoic acid	D.N.J.	2024-05-08	Active	—

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 Nexletol (2023)

Total Spending

$45.5M

Total Claims

63,194

Beneficiaries

18,619

Avg Cost/Unit

$13.72

Spending Trend

$3.1M(2020)→$18.0M(2021)→$29.0M(2022)→$45.5M(2023)

YoY Change:+3.6%

5yr CAGR:+7.5%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain17 active DMFs

16 active API suppliers hold Drug Master Files for this ingredient.

OPTIMUS DRUGS PRIVATE LTDBEMPEDOIC ACID

DMF 359562021

LEE PHARMA LTDBEMPEDOIC ACID

DMF 360102021

METROCHEM API PRIVATE LTDBEMPEDOIC ACID

DMF 360852021

APICHEM LABORATORIES PRIVATE LTDBEMPEDOIC ACID

DMF 367732022

DR REDDYS LABORATORIES LTDBEMPEDOIC ACID

DMF 369332022

YANGZHOU AURISCO PHARMACEUTICAL CO LTDBEMPEDOIC ACID

DMF 369422022

AMI LIFESCIENCES PRIVATE LTDBEMPEDOIC ACID

DMF 375112022

MICRO LABS LTDBEMPEDOIC ACID

DMF 377882023

EVEREST ORGANICS LTDBEMPEDOIC ACID

DMF 379732023

ALKEM LABORATORIES LTDBEMPEDOIC ACID

DMF 387132023

HONOUR LAB LTDBEMPEDOIC ACID

DMF 387852023

BIOPHORE INDIA PHARMACEUTICALS PVT LTDBEMPEDOIC ACID

DMF 387862023

APITORIA PHARMA PRIVATE LTDBEMPEDOIC ACID

DMF 388112023

SHANDONG NEW TIME PHARMACEUTICAL CO LTDBEMPEDOIC ACID

DMF 398312024

YANGZHOU AURISCO PHARMACEUTICAL CO LTDBEMPEDOIC ACID (PROCESS II)

DMF 413692025

SYNTHIMED LABS PRIVATE LTDBEMPEDOIC ACID

DMF 425722025

MOREPEN LABORATORIES LTDBEMPEDOIC ACID

DMF 427002025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Jan 16, 2026	SUPPL -26	View Letter (PDF)
Nov 24, 2025	SUPPL -24	View Letter (PDF)
Jul 22, 2025	SUPPL -22	View Letter (PDF)
Jul 22, 2025	SUPPL -23	View Letter (PDF)
Mar 25, 2024	SUPPL -12	View Letter (PDF)
Mar 25, 2024	SUPPL -13	View Letter (PDF)
Sep 21, 2023	SUPPL -14	View Letter (PDF)
Feb 25, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 180MG

RLD

7 patents2 exclusivities▴

TABLET;ORAL | Approved: Feb 21, 2020

Patents (7)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7335799	Dec 3, 2030	—	Yes	—	—	—
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-944	Mar 22, 2027	< 1 year