Viewing data from:

IPRATROPIUM BROMIDE

ANDA

IPRATROPIUM BROMIDE | A217953 | ARMSTRONG PHARMACEUTICALS INC

1 strength0 unique patents1 unique exclusivity

Reference Listed Drug: ATROVENT HFA(TE code: AB)

Patent Timeline

0 unique patents, 1 exclusivity by expiration date

TodayExclusivity

Today

Oct. 13, 2026

Medicare Part B Spending

CMS physician-administered drug spending for Ipratropium Bromide (2023)

Total Spending

$1.3M

Total Claims

126,931

Beneficiaries

44,916

ASP Price

—

HCPCS: J7644 — Ipratropium bromide, inhalation solution, fda-approved final product, non-compounded, administered through dme, unit dose form, per milligram

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain7 active DMFs2 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

OLON SPAIPRATROPIUM BROMIDE

DMF 89731991

LUSOCHIMICA SPAIPRATROPIUM BROMIDE

DMF 89791991

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGIPRATROPIUM BROMIDE MONOHYDRATE

DMF 142591999

NEULAND LABORATORIES LTDIPRATROPIUM BROMIDE USP

DMF 151302000

AARTI PHARMALABS LTDIPRATROPIUM BROMIDE

DMF 211792007

AMPHASTAR NANJING PHARMACEUTICALS INCIPRATROPIUM BROMIDE USP

DMF 310362017

SCL LIFESCIENCES LTDIPRATROPIUM BROMIDE USP

DMF 379412025

DERIVADOS QUIMICOS SA FINE CHEMICALSInactiveIPRATROPIUM BROMIDE

DMF 231352009

CIPLA LTDInactiveIPRATROPIUM BROMIDE USP

DMF 298432015

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 2, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.021MG/INH

0 patents1 exclusivity▴

AEROSOL, METERED;INHALATION | Approved: Feb 23, 2026

Exclusivities (1)

Code	Date	Status
PC	Oct 13, 2026	< 1 year

Change History (1)

Recent changes detected for this application.

ADDED7/1/2026

Armstrong Pharmaceuticals' Ipratropium Bromide (NDA 217953) gained pediatric exclusivity, extending regulatory exclusivity protection by six months.

New: New record