Viewing data from:

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

2 trials from ClinicalTrials.gov, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Pharmacokinetics and Safety Study of PT010 in Healthy Subjects NCT02189304	Phase 1	Completed	Pearl Therapeutics, Inc.	59	2014-06-01 → 2014-09-01
A Study to Assess the PK and Safety of PT010 in Subjects With COPD Following Single and Repeat Dose NCT03250182	Phase 1	Completed	Pearl Therapeutics, Inc.	30	2017-08-11 → 2017-12-07

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

$61.45

per gm

Lowest NADAC/Unit

$61.31

per gm

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00310461639BREZTRI AEROSPHERE 160-9-4.8 MCG	$61.45	GM	Brand	—	2026-06-17
00310461612BREZTRI AEROSPHERE 160-9-4.8 MCG	$61.31	GM	Brand	—	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

$177.52

Highest Price

$606.17

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00310-4616-12BREZTRI 160/9/4.8MCG ACT INH,ORAL,10.7GM	$606.17	FSS	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026
00310-4616-12BREZTRI 160/9/4.8MCG ACT INH,ORAL,10.7GM	$492.85	Big4	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026
00310-4616-39BREZTRI 160/9/4.8MCG ACT INH,ORAL, 5.9GM	$334.26	FSS	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026
00310-4616-39BREZTRI 160/9/4.8MCG ACT INH,ORAL, 5.9GM	$177.52	Big4	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026

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

Medicare Part D Spending

CMS annual spending data for Breztri Aerosphere (2024)

Total Spending

$1.1B

Total Claims

1,431,108

Beneficiaries

367,055

Avg Cost/Unit

$58.03

Spending Trend

$4.8M(2020)→$179.3M(2021)→$459.4M(2022)→$795.9M(2023)→$1.1B(2024)

YoY Change:-6.2%

5yr CAGR:+0.7%

Source: CMS Medicare Part D Spending by Drug (2024). 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) · 7 use codes

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