Ipratropium Bromide

Treats bronchospasm associated with chronic obstructive pulmonary disease (COPD)…. Sold as Atrovent, Atrovent Hfa. Every FDA application for this active ingredient: 5 branded and 28 generic.

As of Nov 13, 2026, FDA lists 33 applications for Ipratropium Bromide (sold as Atrovent, Atrovent Hfa), first approved Dec 29, 1986, with 3 new uses approved and 0 published complete response letters.

First approved: Dec 29, 1986
Applications: 33
New uses approved: 3
Complete response letters: 0
Medicare spending, 2025: $132M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Ipratropium Bromide	Part D	$65.6M	+2%	980,684
Atrovent HFA	Part D	$65.1M	-44%	56,936
Ipratropium Bromide	Part B	$1.2M	-10%	29,123

Clinical Trials

6 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Efficacy of Nebulized Long-Acting Bronchodilators (Formoterol and Revefenacin) vs. Short-Acting Bronchodilators (Albuterol and Ipratropium) in Patients Presenting to the Emergency Department With Acute Exacerbation of COPD (ECOPD)COPD Exacerbation · University of Tennessee Graduate School of Medicine	Phase 4	Not yet recruiting	Jul 23, 2026
Effect of Ipratropium Bromide on EILOExercise-Induced Laryngeal Obstruction, Dyspnea During Activity · Cook Children's Health Care System	Phase 2	Not yet recruiting	Feb 6, 2026
Nebulized Ketamine Plus Standard Care vs. Standard Care Alone in Moderate to Severe Asthma ExacerbationsAsthma Acute, Asthma Attack · Oman Medical Speciality Board	Phase 2	Recruiting	Aug 8, 2025
Bronchodilators and Lung Mechanics During Exercise in COPDCOPD · Dr. J. Alberto Neder	Phase 4	Recruiting	Feb 13, 2025
Magnesium Trial in Acute Asthma in Emergency DepartmentAsthma · Suzanne Schuh	Phase 3	Recruiting	Jan 21, 2025
Mechanism(s)of Airflow Limitation in Moderate-severe Persistent AsthmaAsthma · Gelb, Arthur F., M.D.	—	Recruiting	Dec 18, 2007

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Dec 29, 1986	AtroventNDA 19085 · New molecular entity	Boehringer Ingelheim	21	Discontinued
Sep 29, 1993	AtroventNDA 20228 · New dosage form	Boehringer Ingelheim	4	Discontinued
Oct 20, 1995	AtroventNDA 20393 · New dosage form	Boehringer Ingelheim	8	Discontinued
Oct 20, 1995	AtroventNDA 20394 · New dosage form	Boehringer Ingelheim	7	Discontinued
Jan 10, 1997	Ipratropium BromideANDA 74755	Pharmobedient	11	Discontinued
Apr 22, 1999	Ipratropium BromideANDA 75111	Actavis Mid Atlantic	9	Discontinued
Feb 7, 2000	Ipratropium BromideANDA 75313	Teva Pharms USA	2	Discontinued
Jan 19, 2001	Ipratropium BromideANDA 75507	Zennova	1	Discontinued
Jan 26, 2001	Ipratropium BromideANDA 75693	Ritedose Corp	6	Marketed
Mar 28, 2001	Ipratropium BromideANDA 75441	Apotex Inc	0	Discontinued
Sep 27, 2001	Ipratropium BromideANDA 75562	Nephron	1	Marketed
Oct 15, 2001	Ipratropium BromideANDA 75835	Bausch	2	Discontinued
Jul 22, 2002	Ipratropium BromideANDA 75867	Roxane	0	Discontinued
Mar 31, 2003	Ipratropium BromideANDA 75553	Aurobindo Pharma USA	1	Discontinued
Mar 31, 2003	Ipratropium BromideANDA 75552	Aurobindo Pharma USA	0	Discontinued
Mar 31, 2003	Ipratropium BromideANDA 76025	Bausch	2	Marketed
Mar 31, 2003	Ipratropium BromideANDA 76103	Bausch	3	Marketed
Apr 18, 2003	Ipratropium BromideANDA 76156	Apotex Inc	2	Marketed
Apr 18, 2003	Ipratropium BromideANDA 76155	Apotex Inc	3	Marketed
Nov 5, 2003	Ipratropium BromideANDA 76598	Hikma	1	Marketed
Nov 5, 2003	Ipratropium BromideANDA 76664	Hikma	1	Marketed
Nov 17, 2004	Atrovent HfaNDA 21527 · New dosage form	Boehringer Ingelheim	12	Marketed
May 9, 2005	Ipratropium BromideANDA 76291	Watson Labs	0	Discontinued
Jul 19, 2005	Ipratropium BromideANDA 77072	Landela Pharm	0	Discontinued
Oct 27, 2016	Ipratropium BromideANDA 206543	Luoxin Aurovitas	0	Marketed
Jan 3, 2017	Ipratropium BromideANDA 207903	Sun Pharm	1	Discontinued
Aug 16, 2022	Ipratropium BromideANDA 215104	Amneal	0	Marketed
Aug 16, 2022	Ipratropium BromideANDA 215105	Amneal	0	Marketed
Nov 15, 2024	Ipratropium BromideANDA 219221	Rubicon Research	0	Marketed
Jan 14, 2025	Ipratropium BromideANDA 219222	Rubicon Research	0	Marketed
Jan 27, 2025	Ipratropium BromideANDA 217886	Lupin	0	Marketed
Feb 7, 2025	Ipratropium BromideANDA 217912	Lupin	0	Marketed
Feb 23, 2026	Ipratropium BromideANDA 217953	Armstrong Pharms	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA