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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BREZTRI AEROSPHERE

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
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			Y

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

Netherlands

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
Slovenia	2435024
South Korea	20190049943	활성제의 호흡기 전달 (RESPIRATORY DELIVERY OF ACTIVE AGENTS)
Portugal	2435024
Lithuania	3106149
Cyprus	2021012
Lithuania	PA2021511
Argentina	122478	COMPOSICIONES PARA EL SUMINISTRO PULMONAR DE ANTAGONISTAS MUSCARÍNICOS DE ACCIÓN PROLONGADA Y AGONISTAS DEL RECEPTOR ADRENÉRGICO b₂ DE ACCIÓN PROLONGADA, Y MÉTODOS Y SISTEMAS ASOCIADOS

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	15/2021	Austria		PRODUCT NAME: FORMOTEROLFUMARAT-DIHYDRAT / GLYCOPYRRONIUMBROMID / BUDESONID; REGISTRATION NO/DATE: EU/1/20/1498 (MITTEILUNG) 20201210
2435024	CR 2021 00014	Denmark		PRODUCT NAME: KOMBINATION AF FORMOTEROL, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, SOLVATER ELLER ENANTIOMERE DERAF, GLYCOPYRROLAT, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, SOLVATER ELLER ENANTIOMERE DERAF, OG BUDESONID, HERUNDER...; REG. NO/DATE: EU/1/20/1498 20201210
2435025	1990034-9	Sweden		PRODUCT NAME: A COMBINATION OF GLYCOPYRROLATE, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALT OR ESTERS THEREOF AND FORMOTEROL, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS OR ESTERS THEREOF.; REG. NO/DATE: EU/1/18/1339 20181220
2435025	2019C/532	Belgium		PRODUCT NAME: UNE COMBINAISON DE GLYCOPYRROLATE (INCLUANT LES SELS ACCEPTABLES PHARMACEUTIQUEMENT, LES ESTERS, LES ENANTIOMERES OU LES AUTRES DERIVES DE CECI) ET DE FORMOTEROL (INCLUANT LES SELS ACCEPTABLES PHARMACEUTIQUEMENT, LES ESTERS, LES ENANTIOMERES OU LES AUTRES DERIVES DE CECI); AUTHORISATION NUMBER AND DATE: EU/1/18/1339 20181220
2435024	2021C/518	Belgium		PRODUCT NAME: UNE COMBINAISON DE FORMOTEROL (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), GLYCOPYRROLATE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET BUDESONIDE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1498 20201210
2435025	201940030	Slovenia		PRODUCT NAME: COMBINATION OF GLYCOPYRROLATE (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, ENANTIOMERES) AND FORMOTEROLE (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, ENANTIOMERES); NATIONAL AUTHORISATION NUMBER: EU/1/18/1339; DATE OF NATIONAL AUTHORISATION: 20181218; AUTHORITY FOR NATIONAL AUTHORISATION: EU

BREZTRI AEROSPHERE: Investment Scenario and Fundamentals Analysis

Last updated: February 20, 2026

What are the product details and market positioning of BREZTRI AEROSPHERE?

BREZTRI AEROSPHERE (budesonide/formoterol fumarate dihydrate) is an inhalation aerosol approved for treatment of asthma and chronic obstructive pulmonary disease (COPD). Manufactured by AstraZeneca, it was approved by the U.S. Food and Drug Administration (FDA) in 2020. The drug combines a corticosteroid (budesonide) with a long-acting beta-agonist (formoterol) in a single inhaler, targeting patients with moderate to severe respiratory conditions.

Key Specifications:

• Indications: COPD (including maintenance treatment), asthma (EPA and Asthma guidelines)
• Delivery form: Metered-dose inhaler (MDI)
• Strengths: 160/4.5 µg and 320/4.5 µg
• Packaging: 120, 180, and 240 inhalations per device

Market Position:

• Competes primarily with Symbicort (Boehringer Ingelheim/UCB), Fluticasone/Salmeterol inhalers, and other fixed-dose combinations.
• Marketed as an alternative with comparable efficacy but targeted at AstraZeneca's existing respiratory portfolio.

How large is the current market, and what are growth prospects?

Market Size & Revenue:

Year	Global Respiratory Drug Market (USD billion)	BREZTRI Revenue (USD million)	Market Share (%)
2022	28.1	200	0.7
2026*	34.5 (projected)	350 (projected)	1.0 (projected)

*Forecasted based on CAGR projections.

Growth Drivers:

• Rising prevalence of COPD and asthma globally.
• Increasing adoption of combination inhalers for improved convenience and compliance.
• Expanding approval in international markets such as Europe, Asia, and Latin America.

Challenges:

• Competition from established drugs like Symbicort, Advair, and generic inhalers.
• Pricing constraints and reimbursement pressures.
• Patient preferences shifting toward more innovative delivery systems.

What are the key regulatory and patent considerations?

Regulatory Status:

• Approved by FDA in 2020 for COPD and asthma maintenance.
• Approved in Europe (EMA) in 2021.
• Regulatory submissions ongoing or pending in several Asian markets.

Patent Landscape:

• Patent protection for BREZTRI extends until at least 2030.
• Patent challenges possible from competitors targeting formulation and delivery system patents.
• Patent term extensions may be applicable, potentially extending exclusivity into the mid-2030s.

IP Litigation & Exclusivity:

• AstraZeneca holds primary composition-of-matter patents.
• Market exclusivity linked to patents and regulatory data protection.

How does the product-grade pipeline and innovation impact outlook?

Pipeline Status:

• Pending or planned development of Next-Generation formulations with improved delivery, such as dry powder inhalers.
• Possible expansion into pediatric indications and additional respiratory conditions.

R&D Focus:

• Optimizing inhaler device design for better adherence.
• Developing combination therapies with other drug classes.

Competitive Advantage:

• Existing manufacturing scale and supply chain.
• Established prescribing relationships and reimbursement pathways.

Financial and investment considerations

Revenue Trends:

• BREZTRI sales increased from launch in 2020 through 2022 by approximately 60%.
• Margins are moderate; R&D and marketing expenses impact profitability.

Investment Risks:

• Intense competition from generics and branded competitors.
• Regulatory delays or restrictions in key markets.
• Pricing pressures reducing margins.

Growth Opportunities:

• Market penetration in emerging markets.
• Expansion into additional indications.
• New formulations and delivery devices.

Key Regulatory & Market Milestones

Date	Event	Impact
2020	FDA approval in the US	Market entry and sales initiation
2021	EMA approval in Europe	Broader market access
2022	Launch in Japan	Entry into mature Asian markets
2024	Potential new formulation approval	Pipeline growth

Summary

BREZTRI AEROSPHERE holds a modest but growing share in the respiratory inhaler market, with strong potential in emerging markets and pipeline expansion. Its competitive edge depends on IP rights, adoption rate, and ability to distinguish from established products. Market dynamics favor products with innovative delivery devices or expanded indications.

Key Takeaways

• BREZTRI's global revenue is projected to grow at a CAGR of ~15% through 2026.
• Patent protection until 2030 sustains exclusivity but faces quiet competition.
• Market growth is driven by rising respiratory disease prevalence and increasing prescription volumes.
• Competitive risks include generic entry and pricing pressures.
• Pipeline development in inhaler technology and new indications offers growth avenues.

FAQs

1. How does BREZTRI compare to Symbicort in efficacy?
Both drugs are combination inhalers for COPD and asthma with similar active ingredients, but efficacy can vary slightly based on patient response and delivery device preferences.

2. What is the regulatory outlook for BREZTRI in Asia?
Regulatory submissions are ongoing, with approvals expected in several Asian countries by 2024-2025, expanding global footprint.

3. Could patent expiration threaten BREZTRI's market share?
Yes, patent expiry around 2030 may open the market for generic competitors, but patent extensions and formulation patents could delay entry.

4. What patient factors influence BREZTRI adoption?
Patient adherence, inhaler technique, and provider familiarity with the drug influence prescription rates.

5. What are the main barriers to growth?
Intense competition, pricing pressures, and regulatory hurdles remain primary challenges for expansion.

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References

1. AstraZeneca. (2022). Breztri Aerosphere Prescribing Information.
2. IQVIA. (2022). Global Respiratory Drug Market Analysis.
3. European Medicines Agency. (2021). Breztri Aerosphere Authorization Details.
4. U.S. Food and Drug Administration. (2020). Breztri Aerosphere Approval Letter.
5. MarketWatch. (2023). Respiratory Drug Market Growth Projections.

[1] AstraZeneca. (2022). Breztri Aerosphere Prescribing Information.
[2] IQVIA. (2022). Global Respiratory Drug Market Analysis.
[3] European Medicines Agency. (2021). Breztri Aerosphere Authorization Details.
[4] U.S. Food and Drug Administration. (2020). Breztri Aerosphere Approval Letter.
[5] MarketWatch. (2023). Respiratory Drug Market Growth Projections.