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SYMBICORT AEROSPHERE

NDA

BUDESONIDE; FORMOTEROL FUMARATE | N216579 | ASTRAZENECA PHARMACEUTICALS LP

2 strengths2 unique patents2 unique exclusivities

Patent Timeline

2 unique patents, 2 exclusivities by expiration date

Active (2)TodayExclusivity

2027

2028

2029

2030

Today

9415009

May. 28, 2030

10716753

May. 28, 2030

I-988

Apr. 27, 2029

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

125 trials from ClinicalTrials.gov — 1 recruiting, 106 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Mechanism(s) of Airflow Limitation During Exacerbation of Asthma NCT01225913	Phase 4	Recruiting	Gelb, Arthur F., M.D.	50	2007-10 → 2027-06
MONO: Symbicort® Single Inhaler Therapy and Conventional Best Standard Treatment for the Treatment of Persistent Asthma in Adolescents and Adults NCT00242411	Phase 4	Completed	AstraZeneca	1,900	2004-09 → 2006-10
Inhaled BUDESONIDE/FORMOTEROL in Bronchiolitis Obliterans Following Stem Cell Transplantation NCT01560689	Phase 2	Completed	Assistance Publique - Hôpitaux de Paris	32	2008-06 → 2012-07
A Comparison of Symbicort® pMDI 2 x 160/4.5 μg Bid and 2 x 80/4.5 μg Bid With Formoterol Turbuhaler® 2 x 4.5 μg Bid and Placebo in Patients With COPD NCT00206167	Phase 3	Completed	AstraZeneca	1,600	2005-04 → 2007-09
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
STYLE - Symbicort Single Inhaler Therapy vs Conventional Therapy in Treatment of Persistent Asthma NCT00252824	Phase 3	Completed	AstraZeneca	1,000	2005-07 → 2006-12
Evaluation of Efficacy on Exercise Tolerance of Symbicort (Budesonide/Formoterol) Compared to Placebo and Oxis in Patients With Severe COPD NCT00489853	Phase 4	Completed	AstraZeneca	137	2007-07 → 2008-08
Evaluation of Safety and Efficacy of Symbicort® pMDI, With or Without Spacer, in Children (6-11 Years) With Asthma NCT00536913	Phase 3	Completed	AstraZeneca	107	2007-09 → 2008-02
Efficacy and Safety Study of Symbicort® Turbuhaler® Versus Oxis® Turbuhaler® in Chronic Obstructive Pulmonary Disease (COPD) Patients NCT01069289	Phase 3	Completed	AstraZeneca	1,293	2010-01 → 2011-03
Assessment of Bronchodilator Efficacy of Formoterol/Budesonide 12/400 mcg Via Discair in COPD NCT03028701	Phase 4	Completed	Neutec Ar-Ge San ve Tic A.Ş	33	2015-09 → 2017-03

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 1, 2026	SUPPL -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 0.16MG/INH;0.0048MG/INH

RLD

2 patents1 exclusivity▴

AEROSOL, METERED;INHALATION | Approved: Apr 28, 2023

Patents (2) · 4 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9415009	May 28, 2030	—	—	—		—
10716753	May 28, 2030	—	—	Yes		—

Exclusivities (1)

Code	Date	Status
I-988	Apr 27, 2029	Active

#002 — 0.08MG/INH;0.0048MG/INH

RLD

2 patents1 exclusivity▾

AEROSOL, METERED;INHALATION | Approved: Apr 27, 2026