BREZTRI AEROSPHERE Drug Patent Profile

When do Breztri Aerosphere patents expire, and what generic alternatives are available?

Breztri Aerosphere is a drug marketed by Astrazeneca Ab and is included in one NDA. There are nine patents protecting this drug.

This drug has two hundred and sixteen patent family members in thirty-four countries.

The generic ingredient in BREZTRI AEROSPHERE is budesonide; formoterol fumarate; glycopyrrolate. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the budesonide; formoterol fumarate; glycopyrrolate profile page.

DrugPatentWatch^® Generic Entry Outlook for Breztri Aerosphere

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 28, 2030. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for BREZTRI AEROSPHERE

International Patents:	216
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	3
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BREZTRI AEROSPHERE
DailyMed Link:	BREZTRI AEROSPHERE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for BREZTRI AEROSPHERE

NDA:

212122

Dosage:

AEROSOL, METERED;INHALATION

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for BREZTRI AEROSPHERE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
AstraZeneca	PHASE4
Dr. J. Alberto Neder	PHASE4
Jianxing He	N/A

See all BREZTRI AEROSPHERE clinical trials

Pharmacology for BREZTRI AEROSPHERE

Drug Class	Anticholinergic Cholinergic Muscarinic Antagonist Corticosteroid beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists Cholinergic Antagonists Cholinergic Muscarinic Antagonists Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for BREZTRI AEROSPHERE

BREZTRI AEROSPHERE is protected by nine US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca Ab	BREZTRI AEROSPHERE	budesonide; formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	212122-001	Jul 23, 2020		RX	Yes	Yes
Astrazeneca Ab	BREZTRI AEROSPHERE	budesonide; formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	212122-001	Jul 23, 2020		RX	Yes	Yes			Y
Astrazeneca Ab	BREZTRI AEROSPHERE	budesonide; formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	212122-001	Jul 23, 2020		RX	Yes	Yes
Astrazeneca Ab	BREZTRI AEROSPHERE	budesonide; formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	212122-001	Jul 23, 2020		RX	Yes	Yes			Y
Astrazeneca Ab	BREZTRI AEROSPHERE	budesonide; formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	212122-001	Jul 23, 2020		RX	Yes	Yes

International Patents for BREZTRI AEROSPHERE

When does loss-of-exclusivity occur for BREZTRI AEROSPHERE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

France

Hong Kong

Hungary

Israel

Japan

Lithuania

Luxembourg

Mexico

Montenegro

Norway

Philippines

Poland

Portugal

Russian Federation

San Marino

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering BREZTRI AEROSPHERE around the world.

Country	Patent Number	Title	Estimated Expiration
Croatia	P20200260
Canada	2763936	COMPOSITIONS PERMETTANT L'ADMINISTRATION DE PRINCIPES ACTIFS PAR VOIE RESPIRATOIRE ET METHODES ET SYSTEMES ASSOCIES (COMPOSITIONS FOR RESPIRATORY DELIVERY OF ACTIVE AGENTS AND ASSOCIATED METHODS AND SYSTEMS)
Israel	216468	תרכובות פרמצבטיות למתן באמצעות משאף מינוני המכילות גליקופירולט ופורמוטרול ושמושן לטיפול במחלות נשימתיות (Pharmaceutical compositions deliverable from a metered dose inhaler comprising glycopyrrolate and formoterol and their use in treatment of pulmonary diseases)
Lithuania	C2435024
Cyprus	2019031

Supplementary Protection Certificates for BREZTRI AEROSPHERE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435025	LUC00124	Luxembourg		PRODUCT NAME: UNE COMBINAISON DE GLYCOPYRROLATE (Y COMPRIS SES SELS, ESTERS, ENANTIOMERES OU AUTRES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, ENANTIOMERES OU AUTRES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/18/1339 20181220
2435024	C202130025	Spain		PRODUCT NAME: UNA COMBINACION DE FORMOTEROL ( INCLUIDAS SUS SALES, ESTERES, SOLVATOS O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES I, GLICOPIRROLATO ( INCLUIDAS SUS SALES, ESTERES, SOLVATOS O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES ) Y BUDESONIDA ( INCLUIDAS SUS SALES, ESTERES, SOLVATOS O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES ).; NATIONAL AUTHORISATION NUMBER: EU/1/20/1498; DATE OF AUTHORISATION: 20201209; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1498; DATE OF FIRST AUTHORISATION IN EEA: 20201209
2435025	300995	Netherlands		PRODUCT NAME: COMBINATIE VAN GLYCOPYRRONIUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER, IN HET BIJZONDER GLYCOPYRRONIUYM BROMIDE, EN FORMOTEROL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER, IN HET BIJZONDER FORMOTEROL FUMARAAT DIHYDRAAT; REGISTRATION NO/DATE: EU/ 1/18/1339 20181220
2435024	2190014-7	Sweden		PRODUCT NAME: A COMBINATION OF FORMOTEROL INCLUDING ANY PHARMACEUUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, GLYCOPYRROLATE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, AND BUDESONIDE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALT, ESTERS ORSOLVATES THEREOF; REG. NO/DATE: EU/1/20/1498 20201210
2435025	132019000000087	Italy		PRODUCT NAME: UNA COMBINAZIONE DI GLICOPIRROLATO (INCLUSI SUOI SALI, ESTERI, ENANTIOMERI O ALTRI DERIVATI FARMACEUTICAMENTE ACCETTABILI) E FORMOTEROLO (INCLUSI SUOI SALI, ESTERI, ENANTIOMERI O ALTRI DERIVATI FARMACEUTICAMENTE ACCETTABILI)(BEVESPI AEROSPHERE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1339, 20181220

Market Dynamics and Financial Trajectory for BREZTRI AEROSPHERE

Last updated: July 27, 2025

Introduction

BREZTRI AEROSPHERE (budesonide/glycopyrrolate/formoterol fumarate inhalation aerosol) represents a significant advancement in inhaled combination therapy for chronic obstructive pulmonary disease (COPD). Approved by the FDA in 2020 and developed by AstraZeneca, BREZTRI AEROSPHERE aims to optimize symptom management, reduce exacerbation risks, and enhance patient adherence through its triple-therapy formulation. Analyzing its market dynamics and financial trajectory offers strategic insights for stakeholders navigating the evolving respiratory therapeutics landscape.

Market Overview

The global COPD therapeutics market is projected to reach approximately $17.9 billion by 2027, growing at a compound annual growth rate (CAGR) of around 4.5% (1). The increasing global prevalence—estimated at over 200 million cases—primarily driven by aging populations, smoking rates, and environmental pollutants underpins this growth. Within this framework, inhaled therapies like LABAs (long-acting beta-agonists), LAMAs (long-acting muscarinic antagonists), ICS (inhaled corticosteroids), and their combinations remain essential.

Positioning of BREZTRI AEROSPHERE

BREZTRI AEROSPHERE addresses the need for effective triple therapy delivered via a single inhaler, aligning with clinical guidelines such as GOLD (Global Initiative for Chronic Obstructive Lung Disease), which recommends personalized inhaler regimens containing ICS, LABA, and LAMA for moderate-to-severe COPD (2). Its unique formulation combines budesonide (ICS), glycopyrrolate (LAMA), and formoterol fumarate (LABA), promising rapid onset, sustained delivery, and improved compliance.

Competitive Landscape

Key competitors include:

• Trimbow (chlorofluorocarbon-free triple therapy inhaler)
• Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol)
• Dulera (mometasone/formoterol)

However, BREZTRI’s differentiated triple combination, delivered via the AEROSPHERE inhaler—known for efficient drug delivery and minimal deposition in the oropharynx—positions it favorably. Moreover, AstraZeneca's marketing strength and established presence in COPD management support rapid adoption.

Market Entry and Adoption Dynamics

Since its launch, BREZTRI AEROSPHERE has experienced swift market penetration, particularly in North America and Europe. The initiation was bolstered by:

• Clinical Efficacy: Phase III trials demonstrated non-inferiority and, in some endpoints, superiority in reducing exacerbations compared to dual therapies.
• Regulatory Approvals: FDA approval in 2020 and subsequent EMA approval facilitated broad access.
• Physician Acceptance: Growing awareness of benefits in adherence and disease control contributed to prescribing trends.

Nevertheless, challenges persist, such as:

• Inhaler Heterogeneity: The specific AEROSPHERE device’s familiarity compared to existing inhalers influences uptake.
• Pricing and Reimbursement: Cost considerations, especially within different healthcare systems, impact patient access.
• Patent Life and Biosimilar Entry: Patent protections shape pricing and market share; potential biosimilar or generic competitors could alter dynamics.

Financial Trajectory and Revenue Outlook

AstraZeneca’s strategic forecast anticipates steady revenue growth from BREZTRI AEROSPHERE, aligning with overall COPD drug sales which are projected to grow at a CAGR of approximately 4-5% over the next five years (3). Key factors influencing financial trajectory include:

• Market Penetration Rates: Early adoption in North America is expected to mature, with growth opportunities in Europe and emerging markets.
• Pricing Strategies: Premium pricing tailored to clinical benefits and device innovation stabilizes margins.
• Expanding Indications: Ongoing trials exploring use in other respiratory conditions could broaden revenue streams.

Initial post-launch sales suggest a trajectory of approximately $700 million globally in 2022, with projections indicating surpassing $1 billion by 2025 as market penetration deepens and awareness improves.

Regulatory and Market Expansion

Future growth depends on approvals in additional jurisdictions like Asia-Pacific, Latin America, and the Middle East. Regulatory agencies’ acceptance hinges on demonstrating safety, efficacy, and device compatibility, especially in diverse populations with varying disease burdens.

Market Challenges and Risks

Risks that may hinder financial growth include:

• Pricing Pressures: Payer negotiations and copayment limitations can constrain revenue.
• Competitive Innovations: Disruptive new inhaler devices or oral therapies threatening inhaled regimens.
• Patent Expirations: Patent cliffs may lead to generic entries, reducing pricing power.

Conclusion

BREZTRI AEROSPHERE’s market dynamics are characterized by robust adoption driven by clinical efficacy, device innovation, and favorable regulatory environments. Its financial trajectory reflects steady growth potential within a lucrative, expanding COPD market. Strategic alignment with evolving clinical guidelines and expansion into emerging markets underpin its revenue prospects, positioning AstraZeneca favorably amid competitive pressures.

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Key Takeaways

• BREZTRI AEROSPHERE has rapidly established itself as a key player in triple-drug COPD therapy, leveraging innovative inhaler technology and strong clinical data.
• The global COPD market’s growth, driven by rising prevalence and aging populations, provides a fertile landscape for BREZTRI’s continued expansion.
• Early adoption in North America, coupled with plans for global expansion, underpins forecasted revenue exceeding $1 billion by 2025.
• Market challenges include pricing pressures, potential biosimilar competition, and regulatory hurdles in emerging markets.
• Long-term success hinges on ongoing clinical trials, device enhancements, and expansion into other respiratory indications.

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FAQs

1. What distinguishes BREZTRI AEROSPHERE from other COPD inhalers?
BREZTRI uses the AEROSPHERE inhaler, designed for rapid and efficient drug delivery with low oropharyngeal deposition, improving efficacy and tolerability relative to traditional devices.

2. How does BREZTRI’s clinical efficacy compare to dual therapy alternatives?
Clinical trials show BREZTRI effectively reduces exacerbations and improves lung function, often outperforming dual therapy options, aligning with GOLD guidelines for severe COPD management.

3. What are the primary markets driving BREZTRI’s revenue growth?
The United States and Europe are currently the main markets, with expansion into Asia-Pacific and Latin America expected to bolster growth over the next few years.

4. What impact do patent protections have on BREZTRI’s future sales?
Patent protections secure exclusivity, enabling premium pricing; however, patent expirations could lead to generic competition, impacting market share and revenue.

5. What are the key risks to BREZTRI’s market and financial prospects?
Major risks include pricing and reimbursement challenges, market commoditization through biosimilars, regulatory delays, and potential competition from emerging therapies or inhaler devices.

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Sources

1. Grand View Research, “COPD Treatment Market Size, Share & Trends Analysis Report,” 2022.
2. GOLD Report, “Global Strategy for the Diagnosis, Management, and Prevention of COPD,” 2023.
3. EvaluatePharma, “Worldwide COPD Drug Sales Forecast,” 2022.