Viewing data from:

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

No clinical trials found on ClinicalTrials.gov for this drug

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)

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

Change History (4)

Recent changes detected for this application.

ADDED7/1/2026

AstraZeneca gained new drug substance exclusivity for Symbicort AeroSphere (budesonide/formoterol fumarate) under NDA 216579.

New: New record

ADDED7/1/2026

AstraZeneca added U.S. Patent 10,716,753 to the Orange Book for Symbicort AeroSphere (budesonide/formoterol fumarate) NDA 216,579.

New: New record

ADDED7/1/2026

AstraZeneca added U.S. Patent 9,415,009 to the Orange Book for Symbicort Aerosphere (budesonide/formoterol fumarate).

New: New record

ADDED7/1/2026

AstraZeneca added a new regulatory exclusivity designation (I-988) to the Orange Book for Symbicort Aerosphere (budesonide/formoterol fumarate), NDA 216579.

New: New record