Assyro AI

Orange Book product · Brand (NDA)

IQIRVO

ELAFIBRANOR

Brand (NDA)NDA 218860RX IPSEN

At a glance

Jun 10, 2024

Approved

Brand (NDA)

Application

Not listed

TE code

9

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 10, 2024

    2 yr 1 mo ago

  2. Today

  3. Exclusivity ends · NCE

    New chemical entity exclusivity (5 years)

    Jun 10, 2029

    in 3 yr

  4. Exclusivity ends · ODE-486

    Orphan-drug exclusivity (7 years)

    Jun 10, 2031

    in 5 yr 1 mo

  5. Patent 11185519 expires

    Listed method-of-use patent (U-3955) expiration.

    Mar 30, 2037

    in 10 yr 11 mo

  6. Patent 11331292 expires

    Listed method-of-use patent (U-1854) expiration.

    Mar 30, 2037

    in 10 yr 11 mo

  7. Patent 11850223 expires

    Listed method-of-use patent (U-1854) expiration.

    Mar 30, 2037

    in 10 yr 11 mo

  8. Patent 11857523 expires

    Listed method-of-use patent (U-3955) expiration.

    Mar 30, 2037

    in 10 yr 11 mo

  9. Patent 12233038 expires

    Listed method-of-use patent (U-1854) expiration.

    Mar 30, 2037

    in 10 yr 11 mo

  10. Patent 12295927 expires

    Listed method-of-use patent (U-1854) expiration.

    Mar 30, 2037

    in 10 yr 11 mo

  11. Patent 12295928 expires

    Listed method-of-use patent (U-1854) expiration.

    Mar 30, 2037

    in 10 yr 11 mo

  12. Patent 12310935 expires

    Listed method-of-use patent (U-1854) expiration.

    Mar 30, 2037

    in 10 yr 11 mo

  13. Patent 12589086 expires

    Listed method-of-use patent (U-4473) expiration.

    Mar 30, 2037

    in 10 yr 11 mo

Pharmaceutical detail

Active ingredient

ELAFIBRANOR

Strength

80MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 218860

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)

  • NCENew chemical entity exclusivity (5 years)

    Jun 10, 2029

    in 3 yr

  • ODE-486Orphan-drug exclusivity (7 years)

    Jun 10, 2031

    in 5 yr 1 mo

Listed patents (9)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11185519Mar 30, 2037in 10 yr 11 mo
U-3955
11331292Mar 30, 2037in 10 yr 11 mo
U-1854
11850223Mar 30, 2037in 10 yr 11 mo
U-1854
11857523Mar 30, 2037in 10 yr 11 mo
U-3955
12233038Mar 30, 2037in 10 yr 11 mo
U-1854
12295927Mar 30, 2037in 10 yr 11 mo
U-1854
12295928Mar 30, 2037in 10 yr 11 mo
U-1854
12310935Mar 30, 2037in 10 yr 11 mo
U-1854
12589086Mar 30, 2037in 10 yr 11 mo
U-4473
Agent CTA Background

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