Assyro AI

Orange Book product · Brand (NDA)

LIVMARLI

MARALIXIBAT CHLORIDE

Brand (NDA)NDA 219485RX MIRUM

At a glance

Apr 10, 2025

Approved

Brand (NDA)

Application

Not listed

TE code

9

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 10, 2025

    1 yr 3 mo ago

  2. Today

  3. Exclusivity ends · NCE

    New chemical entity exclusivity (5 years)

    Sep 29, 2026

    in 3 mo

  4. Exclusivity ends · I-938

    New indication exclusivity (3 years)

    Mar 13, 2027

    in 9 mo

  5. Patent 11260053 expires

    Listed method-of-use patent (U-4187) expiration.

    May 26, 2031

    in 5 yr

  6. Patent 10512657 expires

    Listed method-of-use patent (U-4186) expiration.

    Oct 26, 2032

    in 6 yr 5 mo

  7. Patent 11229661 expires

    Listed method-of-use patent (U-4186) expiration.

    Oct 26, 2032

    in 6 yr 5 mo

  8. Patent 11376251 expires

    Listed method-of-use patent (U-4187) expiration.

    Oct 26, 2032

    in 6 yr 5 mo

  9. Patent 12350267 expires

    Listed method-of-use patent (U-3973) expiration.

    Oct 26, 2032

    in 6 yr 5 mo

  10. Patent 11229647 expires

    Listed method-of-use patent (U-4187) expiration.

    Feb 12, 2040

    in 13 yr 10 mo

  11. Patent 11497745 expires

    Listed method-of-use patent (U-4187) expiration.

    Feb 12, 2040

    in 13 yr 10 mo

  12. Patent 12296050 expires

    Listed drug product patent expiration.

    Oct 05, 2043

    in 17 yr 7 mo

  13. Patent 12296050 expires

    Listed drug product patent expiration.

    Oct 05, 2043

    in 17 yr 7 mo

Pharmaceutical detail

Active ingredient

MARALIXIBAT CHLORIDE

Strength

EQ 10MG BASE

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 219485

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

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)

    Sep 29, 2026

    in 3 mo

  • I-938New indication exclusivity (3 years)

    Mar 13, 2027

    in 9 mo

Listed patents (9)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11260053May 26, 2031in 5 yr
U-4187
10512657Oct 26, 2032in 6 yr 5 mo
U-4186
11229661Oct 26, 2032in 6 yr 5 mo
U-4186
11376251Oct 26, 2032in 6 yr 5 mo
U-4187
12350267Oct 26, 2032in 6 yr 5 mo
U-3973
11229647Feb 12, 2040in 13 yr 10 mo
U-4187
11497745Feb 12, 2040in 13 yr 10 mo
U-4187
12296050Oct 05, 2043in 17 yr 7 mo
ProductU-4186
12296050Oct 05, 2043in 17 yr 7 mo
ProductU-4187
Agent CTA Background

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