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FDA Orange Book · active-ingredient family

Elafibranor

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

Reference-listed drug:IQIRVO · NDA 218860

1

Brand (NDA)

0

Generics (ANDA)

9

Listed patents

2

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
IQIRVORLDIPSENNDA 218860—Jun 10, 2024

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
11857523Mar 30, 2037in 10 yr 11 mo
U-3955
11850223Mar 30, 2037in 10 yr 11 mo
U-1854
11331292Mar 30, 2037in 10 yr 11 mo
U-1854
11185519Mar 30, 2037in 10 yr 11 mo
U-3955
12310935Mar 30, 2037in 10 yr 11 mo
U-1854
12295928Mar 30, 2037in 10 yr 11 mo
U-1854
12295927Mar 30, 2037in 10 yr 11 mo
U-1854
12233038Mar 30, 2037in 10 yr 11 mo
U-1854
12589086Mar 30, 2037in 10 yr 11 mo
U-4473

Elafibranor — 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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