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SYMBICORT

NDA

BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE | N021929 | ASTRAZENECA LP

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

5 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
AstraZeneca AB et al v. Mylan Pharmaceuticals Inc. et al 1:2022cv00035 5 patentsANDA 211699budesonide/formoterol fumarate dihydrate	N.D. W. Va.	2022-04-26	Terminated 2023-03-08	—
AstraZeneca AB et al v. Mylan Pharmaceuticals Inc. et al 1:2019cv00203	N.D. W. Va.	2019-11-04	Terminated 2023-03-08	—
AstraZeneca AB et al v. Teva Pharmaceuticals USA, Inc. 1:2018cv01685 4 patentsANDA 212212budesonide/formoterol fumarate dihydrate	D. Del.	2018-10-26	Terminated 2019-12-04	—
AstraZeneca AB et al v. Mylan Pharmaceuticals Inc. et al 1:2018cv00193 4 patentsANDA 211699budesonide/formoterol fumarate dihydrate	N.D. W. Va.	2018-10-12	Terminated 2023-03-08	—
AstraZeneca AB et al v. Mylan Pharmaceuticals Inc. et al 1:2018cv01562	D. Del.	2018-10-11	Terminated 2019-11-04	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

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.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 6 NDCs (4 brand, 2 generic)

Highest NADAC/Unit

$25.43

per gm

Lowest NADAC/Unit

$16.80

per gm

Brand NDCs

Generic NDCs

Avg Brand: $21.49

Avg Generic: $17.49

19% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00186037028SYMBICORT 160-4.5 MCG INHALER	$25.43	GM	Brand	—	2026-06-17
00186037020SYMBICORT 160-4.5 MCG INHALER	$22.02	GM	Brand	$18.17	2026-06-17
00186037228SYMBICORT 80-4.5 MCG INHALER	$19.26	GM	Brand	—	2026-06-17
00186037220SYMBICORT 80-4.5 MCG INHALER	$19.24	GM	Brand	$16.80	2026-06-17
00310737020BUDESONIDE-FORMOTEROL 160-4.5	$18.17	GM	Generic	—	2026-06-17
00310737220BUDESONIDE-FORMOTEROL 80-4.5	$16.80	GM	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 | 12 NDCs (6 FSS, 6 Big4)

Lowest Price

$50.49

Highest Price

$232.81

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00186-0372-28SYMBICORT 80/4.5MCG HUD	$61.32	FSS	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026
00186-0372-28SYMBICORT 80/4.5MCG HUD	$50.49	Big4	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026
00310-7370-20BUDESONIDE 160MCG/FORMOTEROL FUM 4.5MCG/SPRAY	$229.90	FSS	Prasco, LLC	06/30/2026
00310-7370-20BUDESONIDE 160MCG/FORMOTEROL FUM 4.5MCG/SPRAY	$119.27	Big4	Prasco, LLC	06/30/2026
00186-0370-20SYMBICORT 160/4.5 INHL AEROSOL	$232.81	FSS	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026
00186-0370-20SYMBICORT 160/4.5 INHL AEROSOL	$169.97	Big4	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026

Showing 6 of 12 NDCs.

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

Medicare Part D Spending

CMS annual spending data for Symbicort (2024)

Total Spending

$597.8M

Total Claims

1,913,647

Beneficiaries

588,018

Avg Cost/Unit

$21.94

Spending Trend

$2.0B(2019)→$2.0B(2020)→$2.0B(2021)→$2.0B(2022)→$2.0B(2023)→$597.8M(2024)

YoY Change:-43.7%

5yr CAGR:-11.1%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
Dec 27, 2017	SUPPL -42	View Letter (PDF)
Sep 15, 2017	SUPPL -41	View Letter (PDF)
Jan 31, 2017	SUPPL -13	View Letter (PDF)
Jul 25, 2012	SUPPL -33	View Letter (PDF)
Aug 22, 2011	SUPPL -28	View Letter (PDF)
Feb 18, 2011	SUPPL -19	View Letter (PDF)
Jun 29, 2010	SUPPL -21	View Letter (PDF)
Mar 3, 2009	SUPPL -12	View Letter (PDF)
Jul 17, 2008	SUPPL -10	View Letter (PDF)
Nov 8, 2007	SUPPL -4	View Letter (PDF)
Nov 8, 2007	SUPPL -6	View Letter (PDF)
Jul 21, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 0.08MG/INH;0.0045MG/INH

RLDAB

0 patents0 exclusivities▴

AEROSOL, METERED;INHALATION | Approved: Jul 21, 2006

No patent or exclusivity listings for this strength.

#002 — 0.16MG/INH;0.0045MG/INH

RLDAB

0 patents0 exclusivities▾

AEROSOL, METERED;INHALATION | Approved: Jul 21, 2006