Assyro AI

Orange Book product · Brand (NDA)

LYNAVOY

LINERIXIBAT

Brand (NDA)NDA 220295RX INTERCEPT

At a glance

Mar 17, 2026

Approved

Brand (NDA)

Application

Not listed

TE code

1

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 17, 2026

    3 mo ago

  2. Today

  3. Exclusivity ends · NCE

    New chemical entity exclusivity (5 years)

    Mar 17, 2031

    in 4 yr 10 mo

  4. Patent 9040518 expires

    Listed drug substance patent expiration.

    Sep 06, 2031

    in 5 yr 4 mo

  5. Exclusivity ends · ODE-517

    Orphan-drug exclusivity (7 years)

    Mar 17, 2033

    in 6 yr 10 mo

Pharmaceutical detail

Active ingredient

LINERIXIBAT

Strength

40MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 220295

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)

    Mar 17, 2031

    in 4 yr 10 mo

  • ODE-517Orphan-drug exclusivity (7 years)

    Mar 17, 2033

    in 6 yr 10 mo

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9040518Sep 06, 2031in 5 yr 4 mo
SubstanceProduct
Agent CTA Background

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