Assyro AI

Orange Book product · Generic (ANDA)

PIMOZIDE

PIMOZIDE

Generic (ANDA)ANDA 219897TE ABRX NOVITIUM PHARMA

At a glance

Apr 13, 2026

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 13, 2026

    2 mo ago

  2. Today

  3. Exclusivity ends · CGT

    FDA marketing exclusivity

    Oct 18, 2026

    in 4 mo

Pharmaceutical detail

Active ingredient

PIMOZIDE

Strength

1MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 219897

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of PIMOZIDE

Marketing exclusivity (1)

  • CGTFDA marketing exclusivity

    Oct 18, 2026

    in 4 mo

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Agent CTA Background

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