Assyro AI

Orange Book product · Brand (NDA)

NEXLIZET

BEMPEDOIC ACID; EZETIMIBE

Brand (NDA)NDA 211617RX ESPERION THERAPS INC

At a glance

Feb 26, 2020

Approved

Brand (NDA)

Application

Not listed

TE code

10

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 26, 2020

    6 yr 5 mo ago

  2. Today

  3. Exclusivity ends · I-943

    New indication exclusivity (3 years)

    Mar 22, 2027

    in 9 mo

  4. Exclusivity ends · I-945

    New indication exclusivity (3 years)

    Mar 22, 2027

    in 9 mo

  5. Patent 7335799 expires

    Listed drug substance patent expiration.

    Dec 03, 2030

    in 4 yr 6 mo

  6. Patent 10912751 expires

    Listed method-of-use patent (U-3884) expiration.

    Mar 14, 2036

    in 9 yr 11 mo

  7. Patent 10912751 expires

    Listed method-of-use patent (U-3224) expiration.

    Mar 14, 2036

    in 9 yr 11 mo

  8. Patent 11744816 expires

    Listed method-of-use patent (U-3883) expiration.

    Mar 14, 2036

    in 9 yr 11 mo

  9. Patent 11744816 expires

    Listed method-of-use patent (U-3692) expiration.

    Mar 14, 2036

    in 9 yr 11 mo

  10. Patent 11613511 expires

    Listed drug substance patent expiration.

    Jun 19, 2040

    in 14 yr 2 mo

  11. Patent 11760714 expires

    Listed drug product patent expiration.

    Jun 19, 2040

    in 14 yr 2 mo

  12. Patent 11926584 expires

    Listed method-of-use patent (U-3873) expiration.

    Jun 19, 2040

    in 14 yr 2 mo

  13. Patent 12398087 expires

    Listed drug substance patent expiration.

    Jun 19, 2040

    in 14 yr 2 mo

  14. Patent 12404227 expires

    Listed drug substance patent expiration.

    Jun 19, 2040

    in 14 yr 2 mo

Pharmaceutical detail

Active ingredient

BEMPEDOIC ACID; EZETIMIBE

Strength

180MG;10MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 211617

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

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 (10)

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
10912751Mar 14, 2036in 9 yr 11 mo
U-3884
10912751Mar 14, 2036in 9 yr 11 mo
U-3224
11744816Mar 14, 2036in 9 yr 11 mo
U-3883
11744816Mar 14, 2036in 9 yr 11 mo
U-3692
11613511Jun 19, 2040in 14 yr 2 mo
Substance
11760714Jun 19, 2040in 14 yr 2 mo
Product
11926584Jun 19, 2040in 14 yr 2 mo
U-3873
12398087Jun 19, 2040in 14 yr 2 mo
SubstanceProduct
12404227Jun 19, 2040in 14 yr 2 mo
SubstanceU-4258
Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.