Terbutaline Sulfate

For asthma and reversible bronchospasm associated with bronchitis and emphysema. Sold as Bricanyl, Brethine, Brethaire. Every FDA application for this active ingredient: 6 branded and 9 generic.

As of Nov 15, 2026, FDA lists 15 applications for Terbutaline Sulfate (sold as Bricanyl, Brethine, Brethaire), first approved Mar 25, 1974, with 5 new uses approved and 0 published complete response letters.

First approved: Mar 25, 1974
Applications: 15
New uses approved: 5
Complete response letters: 0
Medicare spending, 2025: $707K

Medicare Spending

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


Terbutaline Sulfate	Part D	$707K	-18%	989
Terbutaline Sulfate	Part B	$0K	-59%	16

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

TERBUTALINE SULFATE 2.5 MG TAB: $0.926 per unitGeneric · -3% in a year
TERBUTALINE SULFATE 5 MG TAB: $0.586 per unitGeneric · -53% in a year

Clinical Trials

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


Comparative Efficacy of IV Dexamethasone vs. Nebulized Terbutaline for Renal Colic Pain in the EDRenal Colic · University of Monastir	Phase 3	Recruiting	May 20, 2025
The Impact of Airway Allergic Diseases on Children's and Parents' Quality of LifePediatric Asthma, Rhinitis, Allergic · Wenjing Zhou	—	Recruiting	Aug 2, 2024
Hot Flashes and Neurovascular Function in WomenHot Flashes, Menopause · Mayo Clinic	Not applicable	Recruiting	Jan 18, 2022
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension · Duke University	—	Recruiting	Feb 20, 2020

Applications

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


Mar 25, 1974	BricanylNDA 17466 · New molecular entity	Sanofi Aventis US	23	Discontinued
Apr 22, 1975	BricanylNDA 17618 · New dosage form	Sanofi Aventis US	33	Discontinued
May 17, 1976	BrethineNDA 17849 · New formulation or manufacturer	Ani Pharms	35	Marketed
Nov 30, 1981	BrethineNDA 18571 · New formulation or manufacturer	Pharmacare	17	Discontinued
Mar 19, 1985	BricanylNDA 18000 · New dosage form	Sanofi Aventis US	0	Discontinued
Jun 26, 2001	Terbutaline SulfateANDA 75877	Impax Labs	1	Marketed
Apr 23, 2004	Terbutaline SulfateANDA 76770	Chartwell Injectable	1	Discontinued
May 26, 2004	Terbutaline SulfateANDA 76887	Fresenius Kabi USA	2	Marketed
Jul 20, 2004	Terbutaline SulfateANDA 76853	Dr Reddys	1	Discontinued
Mar 25, 2005	Terbutaline SulfateANDA 77152	Lannett Co Inc	1	Marketed
Jan 7, 2008	Terbutaline SulfateANDA 78151	Epic Pharma LLC	1	Discontinued
May 20, 2009	Terbutaline SulfateANDA 78630	Hikma Farmaceutica	1	Marketed
Nov 8, 2013	Terbutaline SulfateANDA 200122	Areva Pharms	0	Marketed
Jun 19, 2020	Terbutaline SulfateANDA 211832	Twi Pharms	0	Discontinued
—	BrethaireNDA 18762	Novartis	0	Discontinued

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