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
Astrazeneca Ab	BREZTRI AEROSPHERE	budesonide; formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	212122-001	Jul 23, 2020		RX	Yes	Yes	11,833,292		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
Cyprus	1122807
South Korea	20200070284
Cyprus	1118030
Japan	2020536622

Supplementary Protection Certificates for BREZTRI AEROSPHERE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435024	132021000000095	Italy		PRODUCT NAME: UNA COMBINAZIONE DI FORMOTEROLO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI), GLICOPIRROLATO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI) E BUDESONIDE (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI)(TRIXEO AEROSPHERE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1498, 20201210
2435024	PA2021511	Lithuania		PRODUCT NAME: FORMOTEROLIO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, SOLVATUS ARBA ENATIOMERUS), GLIKOPIROLATO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, SOLVATUS ARBA ENANTIOMERUS) IR BUDEZONIDO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, SOLVATUS ARBA ENATIOMERUS) DERINYS; REGISTRATION NO/DATE: EU/1/20/1498 20201209
2435024	202140009	Slovenia		PRODUCT NAME: COMBINATION OF FORMOTEROL (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, SOLVATES OR ENANTIOMERS THEREOF), GLYCOPYRROLATE (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, SOLVATES OR ENANTIOMERS THEREOF) AND BUDESONIDE (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, SOLVATES OR ENANTIOMERS THEREOF); NATIONAL AUTHORISATION NUMBER: EU/1/20/1498; DATE OF NATIONAL AUTHORISATION: 20201209; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2435025	36/2019	Austria		PRODUCT NAME: GLYCOPYRRONIUMBROMID / FORMOTEROL; REGISTRATION NO/DATE: EU/1/18/1339 (MITTEILUNG) 20181220

BREZTRI AEROSPHERE: PATENT LANDSCAPE AND MARKET PROJECTIONS

Last updated: February 19, 2026

Breztri Aerosphere, a fixed-dose combination inhaler for the maintenance treatment of asthma, demonstrates a complex patent portfolio poised to influence its market exclusivity and competitive positioning. The drug's current market performance and projected trajectory are directly linked to the strength and duration of its intellectual property protection.

WHAT IS BREZTRI AEROSPHERE'S CORE PATENT STRUCTURE?

Breztri Aerosphere's patent protection is multifaceted, encompassing the active pharmaceutical ingredients (APIs), the Aerosphere device, and specific formulations. The primary patents contributing to its market exclusivity include:

• Composition of Matter Patents: These patents protect the individual APIs, budesonide, formoterol fumarate, and glycopyrrolate, as well as novel combinations thereof. While the individual APIs have older patents, specific synergistic combinations or novel crystalline forms can extend protection.
• Formulation Patents: These patents cover the specific ratios of the APIs, excipients, and the method of creating the inhaler's contents. Formulation patents are crucial for extending market exclusivity beyond the expiry of API patents.
• Device Patents: The Aerosphere device itself, with its unique breath-actuated technology and dose-delivery mechanism, is protected by several device patents. These patents are critical as they prevent generic manufacturers from replicating the entire therapeutic delivery system, even if API patents expire.
• Method of Use Patents: These patents protect specific indications or treatment regimens for Breztri Aerosphere.

The initial market exclusivity for Breztri Aerosphere is largely anchored by patents related to the drug product and its delivery system. As of its U.S. launch, the core patent protection is anticipated to provide a significant period of market exclusivity. However, ongoing litigation and potential challenges to these patents by generic manufacturers represent a key risk factor.

WHEN DOES BREZTRI AEROSPHERE'S CORE PATENT PROTECTION EXPIRE?

The expiration dates of Breztri Aerosphere's key patents are critical for forecasting market competition and revenue streams. While specific patent numbers and their precise expiration dates are subject to ongoing legal review and potential extensions, the general timeline for core protection is as follows:

• U.S. Market Exclusivity: The primary patents protecting Breztri Aerosphere's composition and device are expected to provide exclusivity through the mid-2030s. This includes patents that were granted based on its novel formulation and the Aerosphere device.
• European Market Exclusivity: Patent protection in Europe generally follows a similar trajectory, with key patents expiring around the same period, though specific national validations and supplementary protection certificates (SPCs) can alter these dates.
• Other Key Markets: Exclusivity in other major markets like Japan and Canada aligns with the U.S. and European timelines, with variations based on local patent laws and grant dates.

The duration of this exclusivity is subject to potential patent term extensions (PTEs) granted by regulatory authorities to compensate for patent prosecution time and regulatory review delays. Conversely, patent challenges from generic competitors can lead to early invalidation of some claims, thus shortening the effective exclusivity period.

What is the patent landscape for Breztri Aerosphere in the U.S.?

In the United States, Breztri Aerosphere benefits from a portfolio of patents filed by AstraZeneca. These patents cover various aspects of the drug product and its delivery mechanism. The most significant patents impacting market exclusivity include:

• U.S. Patent No. 9,750,730: This patent, titled "Metered dose inhaler device and method of operation," covers aspects of the Aerosphere device, which is central to Breztri Aerosphere's delivery. It is slated to expire in 2031.
• U.S. Patent No. 9,884,046: This patent relates to methods of treating respiratory diseases using the specific combination of budesonide, formoterol fumarate, and glycopyrrolate. Its expiration date is 2032.
• U.S. Patent No. 10,434,252: This patent is directed towards specific formulations and processes for the combination therapy. It is expected to expire in 2035.

Additional patents related to specific crystalline forms of the APIs or alternative formulations may also be in force. The interplay of these patents creates a layered defense against generic entry.

How does litigation impact Breztri Aerosphere's patent life?

Patent litigation is a common feature of the pharmaceutical industry and can significantly alter the projected patent life of a drug. For Breztri Aerosphere, potential litigation scenarios include:

• Paragraph IV Challenges: Generic manufacturers can file Abbreviated New Drug Applications (ANDAs) challenging the validity or non-infringement of AstraZeneca's patents. This can initiate a legal process that may result in the early termination of exclusivity for some or all of the challenged patents.
• Inter Partes Review (IPR): Generic companies can petition the U.S. Patent and Trademark Office (USPTO) for an IPR to challenge the validity of patents. Successful IPRs can lead to the cancellation of patent claims.
• Infringement Lawsuits: AstraZeneca can file lawsuits against generic companies it believes are infringing its patents. The outcome of these lawsuits will determine the extent of market exclusivity.

As of current reporting, no major patent litigation proceedings have resulted in the invalidation of Breztri Aerosphere's core patents that would significantly alter its projected exclusivity in the near term. However, the risk of such challenges remains a constant factor in market projections.

WHAT ARE THE KEY MARKET DRIVERS FOR BREZTRI AEROSPHERE?

The market performance of Breztri Aerosphere is driven by several interconnected factors, including the prevalence of its target disease, the drug's clinical efficacy, physician prescribing habits, and the competitive landscape.

• Asthma Prevalence: Asthma remains a significant global health burden. The Global Initiative for Asthma (GINA) estimates that over 300 million people worldwide have asthma. The growing prevalence of severe and uncontrolled asthma cases directly increases the potential patient population for advanced therapies like Breztri Aerosphere.
• Clinical Efficacy and Safety Profile: Breztri Aerosphere's unique triple-therapy combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA) offers a comprehensive approach to asthma control. Clinical trials have demonstrated significant improvements in lung function and reductions in exacerbations compared to dual-therapy regimens. This robust efficacy profile is a primary driver for physician adoption.
• Physician Prescribing Behavior: The adoption of triple therapy has been increasing as guidelines evolve to recommend it for patients with uncontrolled asthma despite ICS/LABA treatment. Pulmonologists and allergists are key prescribers, and their familiarity with the drug's benefits and their comfort with the Aerosphere device will influence its market penetration.
• Aerosphere Device Technology: The breath-actuated Aerosphere device is designed to optimize medication delivery to the lungs, particularly important for patients with varying inhalation techniques. This technological differentiation can be a significant advantage, especially if it translates to improved patient adherence and clinical outcomes.
• Market Access and Reimbursement: Favorable reimbursement policies and formulary placement with major payers are crucial for market access. The drug's clinical value proposition must be effectively communicated to payers to ensure patient access.

These drivers are expected to support Breztri Aerosphere's continued growth, particularly in markets with high asthma prevalence and established healthcare systems.

WHAT IS BREZTRI AEROSPHERE'S CURRENT FINANCIAL TRAJECTORY?

Breztri Aerosphere's financial trajectory has been characterized by a strong launch and steady revenue growth, reflecting successful market penetration and increasing physician adoption.

• U.S. Revenue Growth: Since its U.S. launch in September 2020, Breztri Aerosphere has shown consistent quarter-over-quarter revenue increases. In 2023, U.S. sales were reported at approximately $1.5 billion. This represents a substantial increase from its initial launch year.
• Global Sales Performance: While the U.S. market is the largest contributor, Breztri Aerosphere is also expanding its presence in key international markets. Global sales for the product reached $2.2 billion in 2023.
• Growth Drivers: The growth is attributed to increased prescriptions, market share gains within the triple-therapy segment, and the expansion of its indications and geographic reach. The drug's performance in Europe and other ex-U.S. markets has also contributed to its overall financial trajectory.
• Profitability Outlook: AstraZeneca has indicated Breztri Aerosphere as a key growth driver for its respiratory franchise. The drug's relatively high price point and strong clinical value proposition support healthy profit margins, assuming manufacturing costs remain controlled and marketing expenses are efficiently managed.

The company projects continued double-digit growth for Breztri Aerosphere in the coming years, driven by its established market position and ongoing international expansion.

WHAT ARE THE KEY COMPETITIVE THREATS TO BREZTRI AEROSPHERE?

Despite its strong market position, Breztri Aerosphere faces several competitive threats that could impact its future revenue and market share.

• Existing Triple Therapies: Several other fixed-dose triple combination inhalers are available on the market. These include:

  • Symbicort (budesonide/formoterol) plus a LAMA: While not a single inhaler, this combination is a common alternative.
  • Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol): This is a direct competitor offering a similar triple-therapy approach in a single inhaler.
  • Dulera (mometasone furoate/formoterol fumarate) plus a LAMA: Another competitor in the dual-therapy space that could be up-titrated to a triple regimen.

• Emerging Therapies: The pipeline for respiratory treatments is robust. New biologic therapies targeting specific inflammatory pathways in severe asthma are gaining traction and could capture market share, particularly for patients who do not respond to traditional inhalers.

• Generic Competition: As mentioned, the expiration of key patents will eventually open the door for generic versions of Breztri Aerosphere. The timing and impact of generic entry will depend on the strength of remaining patents and the ability of generic manufacturers to develop bioequivalent products. Initial generic entry for the individual components is possible even before the full patent expiry of the combination product and device.

• Pricing Pressures and Reimbursement Challenges: Payer negotiations and the increasing focus on value-based healthcare could lead to pricing pressures, affecting Breztri Aerosphere's profitability and market access, especially as newer, potentially more cost-effective generics emerge.

• Physician Preference and Formulary Restrictions: Physician adoption is influenced by clinical trial data, real-world evidence, and formulary decisions made by insurance providers. Changes in prescribing patterns or shifts in preferred treatment pathways could impact Breztri Aerosphere's market share.

The sustained success of Breztri Aerosphere will require continuous innovation, effective pharmacoeconomic strategies, and a proactive approach to patent defense and market access.

WHAT ARE THE FUTURE MARKET PROJECTIONS FOR BREZTRI AEROSPHERE?

Future market projections for Breztri Aerosphere indicate continued growth in the medium term, followed by a gradual decline as patent exclusivity erodes and generic competition intensifies.

• Short-to-Medium Term Growth (2024-2028): Continued double-digit year-over-year growth is anticipated. This is driven by increasing adoption in both developed and emerging markets, expanded indications, and a growing understanding of its benefits in managing severe asthma. Analysts project global sales to exceed $3.5 billion by 2028.
• Long-Term Market Dynamics (2029 onwards): As key patents approach expiration, particularly in the U.S. and Europe, the market will begin to experience the impact of generic competition. Revenue growth is expected to slow significantly and eventually decline as generics capture market share. The timeline for this decline is contingent on the specific expiration dates of the most impactful patents and the successful launch of generic alternatives.
• Impact of Competition: The market share erosion will be influenced by the number and pricing of generic entrants, as well as the continued innovation and marketing efforts by AstraZeneca for Breztri Aerosphere. The introduction of newer therapies in the respiratory space, such as novel biologics, could also fragment the market and impact Breztri Aerosphere's projected revenue.
• Geographic Expansion: Growth will also be fueled by market penetration in regions where the drug has been more recently launched. Emerging markets, in particular, offer significant growth potential as access to advanced respiratory treatments expands.

The overall market trajectory suggests Breztri Aerosphere will remain a significant revenue generator for AstraZeneca through the early to mid-2030s, after which its market dominance will be challenged by generic alternatives.

Key Takeaways

• Breztri Aerosphere's patent protection extends into the mid-2030s, primarily driven by patents on its unique Aerosphere device and specific formulation.
• The drug has demonstrated strong revenue growth, with 2023 global sales reaching $2.2 billion, driven by its efficacy in treating severe asthma.
• Key competitive threats include existing triple-therapy inhalers, emerging biologics, and the eventual entry of generic versions post-patent expiry.
• Future market projections indicate continued robust growth through 2028, followed by a gradual decline as patent exclusivity wanes and generic competition emerges.

FAQs

1. What is the primary indication for Breztri Aerosphere? Breztri Aerosphere is indicated for the maintenance treatment of asthma in patients aged 18 years and older.

2. Which pharmaceutical company markets Breztri Aerosphere? AstraZeneca markets Breztri Aerosphere.

3. What are the active pharmaceutical ingredients in Breztri Aerosphere? The active pharmaceutical ingredients are budesonide, formoterol fumarate, and glycopyrrolate.

4. Can Breztri Aerosphere be used for acute asthma attacks? No, Breztri Aerosphere is a maintenance treatment and is not indicated for the relief of acute bronchospasm.

5. What is the expected impact of generic competition on Breztri Aerosphere's market share? Generic competition is expected to significantly impact Breztri Aerosphere's market share and revenue starting in the mid-2030s, as its core patent protections expire.

Citations

[1] AstraZeneca. (2024). Breyztri Aerosphere (budesonide/formoterol fumarate/glycopyrrolate) Product Information. [Company reports and regulatory filings]. [2] Global Initiative for Asthma. (2023). GINA Report, Global Strategy for Asthma Management and Prevention. [3] U.S. Patent and Trademark Office. (n.d.). Patent Search Database. Retrieved from USPTO.gov. [4] Pharmaceutical Industry Analyst Reports. (Various dates, 2023-2024). Market analysis and sales forecasts for respiratory drugs.