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FDA Orange Book · active-ingredient family

Bempedoic acid; ezetimibe

Bempedoic acid; ezetimibe is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:NEXLIZET · NDA 211617

1

Brand (NDA)

0

Generics (ANDA)

8

Listed patents

2

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
NEXLIZETRLDESPERION THERAPS INCNDA 211617—Feb 26, 2020

Marketing exclusivity (2)

  • I-943New indication exclusivity (3 years)

    Mar 22, 2027

    in 9 mo

  • I-945New indication exclusivity (3 years)

    Mar 22, 2027

    in 9 mo

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 6 mo
Substance
11744816Mar 14, 2036in 9 yr 11 mo
U-3883
10912751Mar 14, 2036in 9 yr 11 mo
U-3884
11926584Jun 19, 2040in 14 yr 2 mo
U-3873
12404227Jun 19, 2040in 14 yr 2 mo
SubstanceU-4258
11613511Jun 19, 2040in 14 yr 2 mo
Substance
11760714Jun 19, 2040in 14 yr 2 mo
Product
12398087Jun 19, 2040in 14 yr 2 mo
SubstanceProduct

Bempedoic acid; ezetimibe — frequently asked questions

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

Agent CTA Background

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