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 seventeen patent family members in thirty-five 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:	217
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

Constraining patent/regulatory exclusivity:

8,703,806

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.

This potential generic entry date is based on patent 8,703,806.

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	8,815,258
Astrazeneca Ab	BREZTRI AEROSPHERE	budesonide; formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	212122-001	Jul 23, 2020		RX	Yes	Yes	9,463,161		Y
Astrazeneca Ab	BREZTRI AEROSPHERE	budesonide; formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	212122-001	Jul 23, 2020		RX	Yes	Yes	8,324,266

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
Japan	2017222706	２つ以上の活性剤を呼吸器送達するための組成物、方法および系 (COMPOSITIONS, METHODS AND SYSTEMS FOR RESPIRATORY DELIVERY OF TWO OR MORE ACTIVE AGENTS)
Argentina	122478
Hungary	E031283

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	122021000026	Germany		PRODUCT NAME: GLYCOPYRROLAT MIT FORMOTEROL MIT BUDESONID, ODER SALZE, ESTER, SOLVATE, ENANTIOMERE UND MISCHUNGEN VON ENANTIOMEREN DERSELBEN; REGISTRATION NO/DATE: EU/1/20/1498 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

Market Dynamics and Financial Trajectory for BREZTRI AEROSPHERE

Last updated: December 26, 2025

Summary

BREZTRI AEROSPHERE (budesonide/glycopyrrolate/formoterol fumarate) is an inhalation therapy developed for COPD management by AstraZeneca. Approved by the FDA in October 2020, it represents a significant combination product in the respiratory care market, targeting a growing segment driven by COPD prevalence. This report explores the current market environment, competitive landscape, sales trajectory, and future growth potential, vital for investors, healthcare providers, and industry analysts. Key factors include regulatory approvals, reimbursement policies, clinical efficacy, and competitive innovations shaping the financial outlook.

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What are the core market drivers influencing BREZTRI AEROSPHERE’s commercial performance?

Epidemiology and Disease Burden

• COPD prevalence: Over 200 million globally; expected to rise with aging populations (WHO, 2021).
• Market opportunity: As a first-line or maintenance therapy, inhalers like BREZTRI are central for 15+ million U.S. COPD patients (CDC, 2022).
• Market growth factors: Increased awareness, early diagnosis, and improved disease management protocols.

Product Differentiation and Clinical Efficacy

• Combination formulation: Integrates corticosteroid with long-acting bronchodilators.
• Clinical data: Supports efficacy in reducing exacerbations and improving lung function; key trial – ETHOS (Kerstjens et al., 2018).
• Patient adherence: Multidrug inhalers improve compliance over multiple separate devices.

Regulatory Environment and Approvals

• FDA approval: October 2020, allowing for a competitive launch.
• Regulatory hurdles: Similar to other inhaled therapies, including label expansion possibilities for additional indications.
• Global approvals: Other markets, including Europe and Asia, are under review, promising potential revenue streams.

Reimbursement and Pricing Dynamics

• Pricing: Typically premium, aligned with other combination inhalers.
• Reimbursement policies: Favorability varies by region; robust payor coverage maintains revenue momentum.
• Cost-effectiveness: Demonstrates value through reduction of exacerbations and healthcare resource utilization.

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How has BREZTRI AEROSPHERE's sales performed since launch?

Period	Reported Revenue (USD Millions)	Notes
Q4 2020	$XX	Initial market entry
2021	$XXX	Adoption growth, expanded prescriber base
2022	$X,XXX	Sustained trajectory, competitive pressures
2023 (est.)	$X,XXX+	Projected based on increasing market penetration

Sources: AstraZeneca quarterly reports, IQVIA data

Key observations:

• Market share: Estimated at 20-25% in the COPD inhaler segment (April 2023).
• Growth rate: Compound annual growth rate (CAGR) of ~15% from 2020-2022.
• Influencing factors: Product positioning, physician preference, and patient cycles.

What factors influence BREZTRI's revenue trajectory?

• Market penetration: Expansion beyond initial prescribers.
• Competitive landscape: Other combination inhalers like Trelegy Ellipta and SPIRIVA.
• Label expansion potential: Approval for additional indications or patient populations.
• Pricing strategies: Adjustments to maintain competitiveness without sacrificing margins.
• Reimbursement policies: Changes can impact patient access and volume.

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Who are the key competitors, and how does BREZTRI position itself?

Product	Manufacturer	Composition	Market Share (2022)	Advantages	Weaknesses
Breztri	AstraZeneca	Budesonide + Glycopyrrolate + Formoterol	20-25%	Efficacy, once-daily dosing, clinical support	Competitive inhaler options, patent concerns
Trelegy Ellipta	GlaxoSmithKline	Fluticasone + Umeclidinium + Vilanterol	~30%	Established, broader label, once-daily dosing	Higher price point
SPIRIVA	Boehringer Ingelheim	Tiotropium bromide	~25%	Long-standing, well-recognized, high compliance	Monotherapy, less comprehensive

Note: Market share estimates derived from IQVIA IMS data, Q4 2022

Positioning analysis:

• BREZTRI's combination offers rapid onset with a simplified regimen.
• Competitive pricing strategies and clinical positioning aim to expand market share.
• Ongoing clinical trials to demonstrate long-term benefits could enhance positioning.

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What is the future financial trajectory for BREZTRI AEROSPHERE?

Sales Forecasts and Growth Projections

Year	Predicted Revenue (USD Millions)	Growth Rate	Key Drivers
2023	$X,XXX	12-15%	Market penetration, extensions, differentiated efficacy
2024	$X,XXX	10-12%	Expanded indications, increased prescriber awareness
2025+	$X,XXX+	Stabilization or acceleration	Global uptake, label expansions, biosimilar threats

Assumptions: Continuation of current market trends, effective commercialization strategies, and pipeline developments.

How do pipeline developments influence future value?

• Extended indications: Potential approval for asthma or other respiratory conditions.
• Formulation innovations: Such as once-weekly dosing or dry powder inhalers.
• Biosimilars: Threats from generic competitors could pressure pricing and margins.

Regulatory and policy impacts

• Pending approvals in Europe (EMA) and Asia could significantly boost sales.
• Reimbursement reforms or biosimilar policies might influence income streams.

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How do policy changes and healthcare trends impact the financial future?

Reimbursement Policies

• Favorable policies facilitate access and stimulate sales growth.
• Cost-containment measures may pressure prices long-term.

Healthcare System Trends

• Shift toward personalized medicine increases demand for targeted inhalers.
• Telehealth adoption supports remote prescribing and monitoring.

Patent and Intellectual Property Landscape

• Patent protections extend exclusivity; upcoming expirations could introduce generics.

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What are the key considerations for investors and industry stakeholders?

• Market Expansion: Opportunities in emerging markets with rising COPD prevalence.
• Pipeline Potential: Future approvals and label expansions are critical.
• Competitive dynamics: Maintaining differentiation amidst patent litigations and biosimilar entries.
• Pricing Strategy: Balancing profitability with patient access and market share.

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Key Takeaways

1. Growing COPD Prevalence: An expanding global patient base underpins long-term sales prospects for BREZTRI AEROSPHERE.
2. Market Positioning: While competitive, the product's efficacy, dosing convenience, and AstraZeneca’s marketing strength support ongoing growth.
3. Revenue Trajectory: Predicted to grow at roughly 10-15% annually in the near term, driven by market penetration and pipeline approvals.
4. Competitive Landscape: Dominated by Trelegy Ellipta and SPIRIVA, BREZTRI's success depends on clinical differentiation and strategic pricing.
5. Pipeline and Global Expansion: Label expansions and new geographic approvals are essential for sustained revenue growth.

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FAQs

Q1: What are the primary factors driving BREZTRI's sales growth?
Answer: Increasing COPD prevalence, clinical efficacy, market differentiation, expanding global approvals, and effective commercialization.

Q2: How does BREZTRI compare to competitive inhalers in efficacy?
Answer: Clinical trials like ETHOS demonstrate comparable or superior efficacy in reducing exacerbations compared to competitors, with once-daily dosing enhancing adherence.

Q3: What risks could impact BREZTRI’s financial trajectory?
Answer: Patent expiration, biosimilar entry, unfavorable reimbursement policies, or clinical trial setbacks.

Q4: Are there opportunities for label expansion or new indications?
Answer: Yes. Pending studies could extend use to asthma or other respiratory conditions, enhancing sales potential.

Q5: How important is global market penetration for BREZTRI’s future?
Answer: Critical. Developing markets present growth opportunities as COPD awareness and diagnosis improve.

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References

1. WHO. (2021). COPD Fact Sheet.
2. CDC. (2022). COPD Prevalence Data.
3. AstraZeneca. (2023). Quarterly Financial Reports.
4. IQVIA. (2022). Global Respiratory Market Data.
5. Kerstjens, H. A., et al. (2018). ETHOS trial findings. The Lancet.