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BRETHINE

NDA

TERBUTALINE SULFATE | N017849 | ANI PHARMACEUTICALS INC

2 strengths0 unique patents0 unique exclusivities

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from ANDA Consultants FDA-2016-P-3162 · 4 docket documents ANDA Consultants filed this citizen petition on October 5, 2016, requesting that the FDA Commissioner designate Terbutaline Sulfate Tablets, 5 mg (ANDA 77-152, held by Lannett Holdings Inc.) as a reference listed drug to serve as the reference standard for bioequivalence testing in subsequent abbrev	Other	2016-10-11	Withdrawn	ANDA Consultants
Citizen Petition from Hikma Farmaceutica of Portugal FDA-2007-P-0407 · 9 docket documents Hikma Farmaceutica of Portugal filed this citizen petition pursuant to 505(q) of the Federal Food, Drug and Cosmetic Act requesting that the FDA determine that Brethine (Terbutaline Sulfate Injection, USP), an approved reference listed drug marketed by aaiPharma under NDA 18-571, was voluntarily wit	505(q)	2008-06-13	Granted	Hikma Farmaceutica of Portugal

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

28 trials from ClinicalTrials.gov, 21 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study to Investigate the Safety and Efficacy of High Dose of Symbicort® SMART in Japanese Patients NCT00837967	Phase 3	Completed	AstraZeneca	25	2009-01 → 2009-07
A Comparison of the Control of Asthma Provided by Symbicort® Turbuhaler® Versus Symbicort® Turbuhaler® Plus Pulmicort® Turbuhaler® Plus Terbutaline Turbuhaler®NCT00244608	Phase 3	Completed	AstraZeneca	100	2005-05 → 2007-03
A Pilot Study to Evaluate the Safety of Terbutaline in Children With Type 1 Diabetes NCT00607503	Phase 1	Completed	Jaeb Center for Health Research	9	2008-02 → 2008-09
Nitroglycerin Versus Terbutaline for Intrapartum Fetal Resuscitation NCT00185887	N/A	Completed	Stanford University	110	2003-10 → 2007-10
Pharmacodynamic Study of Carvedilol Versus Metoprolol in Heart Failure NCT00802230	Phase 4	Completed	University of Utah	25	2002-09 → 2004-12
SHARE - Symbicort and Health Economics in a Real Life Evaluation NCT00259766	Phase 3	Completed	AstraZeneca	1,970	2004-04 → 2007-05
A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma.NCT02149199	Phase 3	Completed	AstraZeneca	3,850	2014-07-07 → 2017-08-02
Role of K+ and Ca2+ in Development of Muscle Fatigue NCT02712658	N/A	Completed	University of Copenhagen	10	2015-09 → 2016-03
To Investigate the Relative Efficacy of Terbutaline Turbuhaler® and Salbutamol Pressurized Metered Dose Inhaler (pMDI) a Single Blind Study NCT01096017	Phase 3	Completed	AstraZeneca	24	2010-03 → 2010-04
Study to Investigate the Efficacy of Symbicort® SMART.NCT00839800	Phase 3	Completed	AstraZeneca	2,091	2009-02 → 2011-02

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$1.12

per ea

Lowest NADAC/Unit

$1.10

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
62559072201TERBUTALINE SULFATE 5 MG TAB	$1.12	EA	Generic	—	2026-06-17
62559072101TERBUTALINE SULFATE 2.5 MG TAB	$1.10	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$1.09

Highest Price

$34.68

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
62559-0721-01TERBUTALINE SO4 2.5MG TAB	$33.75	FSS	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027
62559-0721-01TERBUTALINE SO4 2.5MG TAB	$2.60	Big4	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027
62559-0722-01TERBUTALINE SO4 5MG TAB	$34.68	FSS	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027
62559-0722-01TERBUTALINE SO4 5MG TAB	$1.09	Big4	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain2 active DMFs2 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

CAMBREX PROFARMACO MILANO SRLTERBUTALINE SULFATE

DMF 119271996

MELODY HEALTHCARE PVT LTDTERBUTALINE SULFATE USP

DMF 265632012

CIPLA LTDInactiveTERBUTALINE SULFATE USP

DMF 80621989

INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPAInactiveTERBUTALINE SULFATE

DMF 90651991

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 23, 2003	SUPPL -39	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982