Assyro AI

FDA Orange Book · active-ingredient family

Linerixibat

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

Reference-listed drug:LYNAVOY · NDA 220295

1

Brand (NDA)

0

Generics (ANDA)

1

Listed patents

2

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
LYNAVOYRLDINTERCEPTNDA 220295—Mar 17, 2026

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

Linerixibat — frequently asked questions

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

Agent CTA Background

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

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