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BREZTRI AEROSPHERE

NDA

BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE | N212122 | ASTRAZENECA AB

2 strengths9 unique patents1 unique exclusivity

Patent Timeline

9 unique patents, 1 exclusivity by expiration date

Active (9)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

Today

May. 28, 2030

May. 28, 2030

May. 28, 2030

Mar. 17, 2031

May. 28, 2030

May. 28, 2030

May. 28, 2030

Oct. 5, 2038

Oct. 5, 2038

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

Medicare Part D Spending

CMS annual spending data for Breztri Aerosphere (2023)

Total Spending

$795.9M

Total Claims

954,856

Beneficiaries

257,853

Avg Cost/Unit

$61.88

Spending Trend

$4.8M(2020)→$179.3M(2021)→$459.4M(2022)→$795.9M(2023)

YoY Change:+3.9%

5yr CAGR:+3.2%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
May 1, 2026	SUPPL -9	View Letter (PDF)
Jul 24, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 0.16MG/INH;0.0048MG/INH;0.009MG/INH

RLD

9 patents0 exclusivities▴

AEROSOL, METERED;INHALATION | Approved: Jul 23, 2020

Patents (9)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8324266	May 28, 2030	—	—	—		—
8703806	May 28, 2030	—	—	—		—
8808713	May 28, 2030	—	—	Yes		—
8815258	Mar 17, 2031	—	—	—		—
9415009	May 28, 2030	—	—	—		—
9463161	May 28, 2030	—	—	Yes		—
10716753	May 28, 2030	—	—	Yes		—
11331442	Oct 5, 2038	—	—	Yes	—	—
11833292	Oct 5, 2038	—	—	Yes	—	—

#002 — 0.16MG/INH;0.0048MG/INH;0.018MG/INH

RLD

9 patents1 exclusivity▾

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

Change History (10)

Recent changes detected for this application.

ADDED7/1/2026

AstraZeneca added U.S. Patent 8,815,258 to the Orange Book for Breztri Aerosphere (budesonide/formoterol fumarate/glycopyrrolate) NDA 212122.

New: New record

ADDED7/1/2026

AstraZeneca added U.S. Patent 9,463,161 to the Orange Book for Breztri Aerosphere (budesonide/formoterol fumarate/glycopyrrolate) NDA 212122.

New: New record

ADDED7/1/2026

AstraZeneca AB listed U.S. Patent 8,324,266 in the Orange Book for BREZTRI AEROSPHERE (budesonide, formoterol fumarate, glycopyrrolate).

New: New record

ADDED7/1/2026

AstraZeneca added U.S. Patent 8,808,713 to the Orange Book for Breztri Aerosphere (budesonide/formoterol/glycopyrrolate) NDA 212122.

New: New record

ADDED7/1/2026

AstraZeneca added U.S. Patent 11,833,292 to the Orange Book for Breztri Aerosphere (budesonide/formoterol/glycopyrrolate), NDA 212122.

New: New record

ADDED7/1/2026

AstraZeneca AB added U.S. Patent 8,703,806 to the Orange Book listing for Breztri Aerosphere (budesonide/formoterol/glycopyrrolate).

New: New record

ADDED7/1/2026

AstraZeneca added U.S. Patent 11331442 to the Orange Book for Breztri Aerosphere (budesonide/formoterol/glycopyrrolate), NDA 212122.

New: New record

ADDED7/1/2026

AstraZeneca added U.S. Patent 10,716,753 to the Orange Book for Breztri Aerosphere (budesonide/formoterol fumarate/glycopyrrolate) NDA 212122.

New: New record

ADDED7/1/2026

AstraZeneca added patent 9,415,009 to the Orange Book listing for Breztri Aerosphere (budesonide/formoterol/glycopyrrolate).

New: New record

ADDED7/1/2026

AstraZeneca's Breztri Aerosphere (budesonide/formoterol/glycopyrrolate) gained New Chemical Entity exclusivity under NDA 212122, providing seven years of regulatory protection from generic competition.

New: New record