Assyro AI

Orange Book product · Generic (ANDA)

IPRATROPIUM BROMIDE

IPRATROPIUM BROMIDE

Generic (ANDA)ANDA 217953TE ABRX ARMSTRONG PHARMS

At a glance

Feb 23, 2026

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 23, 2026

    4 mo ago

  2. Today

  3. Exclusivity ends · PC

    Patent-challenge (180-day generic) exclusivity

    Oct 13, 2026

    in 4 mo

Pharmaceutical detail

Active ingredient

IPRATROPIUM BROMIDE

Strength

0.021MG/INH

Dosage form

AEROSOL, METERED

Route

INHALATION

TE code

AB

Application

ANDA 217953

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of IPRATROPIUM BROMIDE

Marketing exclusivity (1)

  • PCPatent-challenge (180-day generic) exclusivity

    Oct 13, 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.