Viewing data from:

ATROVENT HFA

NDA

IPRATROPIUM BROMIDE | N021527 | BOEHRINGER INGELHEIM PHARMACEUTICALS INC

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent (1 delisted) by expiration date

Active (1)TodayDelisted

1 patent delisted from Orange Book — may indicate settlement, invalidation, or voluntary withdrawal

2027

2028

2029

2030

Today

8474447

Jan. 17, 2030Delisted

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Atrovent HFA (2023)

Total Spending

$131.9M

Total Claims

221,950

Beneficiaries

68,099

Avg Cost/Unit

$37.36

Spending Trend

$121.5M(2019)→$131.8M(2020)→$133.7M(2021)→$134.8M(2022)→$131.9M(2023)

YoY Change:+3.9%

5yr CAGR:+5.2%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

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

10 letters from Drugs@FDA

Date	Submission	Document
Jan 2, 2025	SUPPL -42	View Letter (PDF)
Aug 6, 2021	SUPPL -27	View Letter (PDF)
Jan 14, 2020	SUPPL -33	View Letter (PDF)
Aug 31, 2012	SUPPL -21	View Letter (PDF)
Oct 12, 2011	SUPPL -19	View Letter (PDF)
Dec 28, 2010	SUPPL -16	View Letter (PDF)
Oct 22, 2008	SUPPL -11	View Letter (PDF)
Sep 15, 2006	SUPPL -5	View Letter (PDF)
Apr 5, 2006	SUPPL -3	View Letter (PDF)
Dec 2, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.021MG/INH

RLDAB

1 patent0 exclusivities▴

AEROSOL, METERED;INHALATION | Approved: Nov 27, 2004

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8474447	Jan 17, 2030	—	—	Yes	—	Delisted