Assyro AI

Orange Book product · Brand (NDA)

JUXTAPID

LOMITAPIDE MESYLATE

Brand (NDA)NDA 203858RX CHIESI

At a glance

Feb 25, 2026

Approved

Brand (NDA)

Application

Not listed

TE code

2

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 25, 2026

    4 mo ago

  2. Today

  3. Patent 7932268 expires

    Listed method-of-use patent (U-1316) expiration.

    Aug 19, 2027

    in 1 yr 2 mo

  4. Exclusivity ends · NS

    New strength exclusivity (3 years)

    Feb 25, 2029

    in 2 yr 9 mo

  5. Patent 12472172 expires

    Listed method-of-use patent (U-4438) expiration.

    Jul 29, 2041

    in 15 yr 4 mo

Pharmaceutical detail

Active ingredient

LOMITAPIDE MESYLATE

Strength

EQ 2MG BASE

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 203858

Product number

007

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 (1)

  • NSNew strength exclusivity (3 years)

    Feb 25, 2029

    in 2 yr 9 mo

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7932268Aug 19, 2027in 1 yr 2 mo
U-1316
12472172Jul 29, 2041in 15 yr 4 mo
U-4438
Agent CTA Background

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