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FDA Orange Book · active-ingredient family

Bempedoic acid; ezetimibe

Bempedoic acid; ezetimibe: 1 brand, 0 generics; first approved Feb 26, 2020; on patent until Dec 03, 2030.

On patent2 exclusivity periods
Generic status & protection

Protected until Dec 03, 2030 (earliest listed patent expiry).

Earliest patent expiry Dec 03, 2030Latest exclusivity ends Mar 22, 2027
Brands (NDA)
1
Generics (ANDA)
0
Listed patents
8
Next patent expiry
Dec 03, 2030
in 4 yr 5 mo
Originator applications

Brand (NDA) products

NEXLIZETRLDRS
NDA 2116172020
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
180MG;10MGTABLETORALRx—
Protection horizon

Patent & exclusivity timeline

20262028203020322034203620382040TodayExclusivity I-943 — 2027-03-22Exclusivity I-943Exclusivity I-945 — 2027-03-22Exclusivity I-945Patent 7335799 — 2030-12-03Patent 7335799Patent 11744816 — 2036-03-14Patent 11744816Patent 10912751 — 2036-03-14Patent 10912751Patent 11926584 — 2040-06-19Patent 11926584Patent 12404227 — 2040-06-19Patent 12404227Patent 11613511 — 2040-06-19Patent 11613511Patent 11760714 — 2040-06-19Patent 11760714Patent 12398087 — 2040-06-19Patent 12398087
Patent expiryExclusivity endToday
Hatch-Waxman

Marketing exclusivity

Marketing exclusivity (2)

  • I-943New indication exclusivity (3 years)

    Mar 22, 2027

    in 8 mo

  • I-945New indication exclusivity (3 years)

    Mar 22, 2027

    in 8 mo

Orange Book patent file

Listed patents

Listed patents (8)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7335799Dec 03, 2030in 4 yr 5 mo
Substance
11744816Mar 14, 2036in 9 yr 10 mo
U-3883
10912751Mar 14, 2036in 9 yr 10 mo
U-3884
11926584Jun 19, 2040in 14 yr 1 mo
U-3873
12404227Jun 19, 2040in 14 yr 1 mo
SubstanceU-4258
11613511Jun 19, 2040in 14 yr 1 mo
Substance
11760714Jun 19, 2040in 14 yr 1 mo
Product
12398087Jun 19, 2040in 14 yr 1 mo
SubstanceProduct
FDA approval span

Approval history

First approval
Feb 26, 2020
6 yr 6 mo ago
Most recent approval
Feb 26, 2020
6 yr 6 mo ago

All 1 application were approved in 2020.

Brand (NDA) 1100%
Generic (ANDA) 00%

Bempedoic acid; ezetimibe — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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