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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 nine 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.

Indicators of Generic Entry

Summary for breztri aerosphere

International Patents:	209
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
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
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

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
Japan	2012528792
Brazil	PI1011220
Hong Kong	1169027	用於經由呼吸道輸送活性劑的組成物以及相關方法與系統 (COMPOSITIONS FOR RESPIRATORY DELIVERY OF ACTIVE AGENTS AND ASSOCIATED METHODS AND SYSTEMS)

Supplementary Protection Certificates for breztri aerosphere

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
2435025	C201930043	Spain		PRODUCT NAME: UNA COMBINACION DE GLICOPIRROLATO (INCLUYENDO CUALQUIERA DE SUS SALES, ESTERES O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES) Y FORMOTEROL (INCLUYENDO CUALQUIERA DE SUS SALES, ESTERES O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES).; NATIONAL AUTHORISATION NUMBER: EU/1/18/1339; DATE OF AUTHORISATION: 20181218; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1339; DATE OF FIRST AUTHORISATION IN EEA: 20181218

Breztri aerosphere Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Breztri Aerosphere

Introduction

Breztri Aerosphere, a triple-combination therapy inhaler developed by AstraZeneca, has been making significant waves in the chronic obstructive pulmonary disease (COPD) market. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting its clinical successes, market positioning, and financial implications.

Clinical Successes and Trials

Breztri Aerosphere has demonstrated impressive clinical results, particularly in the Phase III ETHOS trial. This trial showed that Breztri Aerosphere reduced exacerbations in patients with moderate to severe COPD by 24% compared to dual-drug combination therapies over 52 weeks[1][4].

The ETHOS trial built upon the promising data from the KRONOS trial, which led to Breztri Aerosphere's first approval by the Japanese Ministry of Health, Labor and Welfare in June 2019. These positive results have set the stage for anticipated rapid approvals in the EU and US, further solidifying AstraZeneca's position in the COPD market[1].

Market Positioning

AstraZeneca is entering a market where GlaxoSmithKline's (GSK) Trelegy Ellipta has already established a presence. However, AstraZeneca's extensive experience and the familiarity of physicians with its predecessor, Symbicort (budesonide/formoterol fumarate), are expected to drive significant uptake of Breztri Aerosphere. Symbicort has consistently outperformed GSK's Relvar Ellipta in sales, indicating a strong potential for Breztri in the triple-combination therapy segment[1].

Key opinion leaders have indicated a preference for switching patients from separate ICS/LABA and LAMA devices to a single ICS/LABA/LAMA device to improve adherence. This trend is expected to boost Breztri Aerosphere's market access strategy[1].

Financial Trajectory

Revenue Projections

Breztri Aerosphere is anticipated to achieve blockbuster sales levels over the next decade. The combination of promising trial data, variable dosing, and the advanced Aerosphere Delivery Technology is expected to drive swift uptake and significant revenue growth. AstraZeneca's extensive marketing experience will also play a crucial role in catapulting sales and overcoming the late market entry[1].

Financial Performance of AstraZeneca

In 2022, AstraZeneca reported a total revenue increase of 25% to $11.207 billion, with a strong pipeline progress and multiple approvals in major markets. The company expects another year of double-digit revenue growth in 2023, excluding COVID-19 medicines. This growth trajectory sets a positive backdrop for the financial performance of Breztri Aerosphere[2].

Regional Sales and Market Impact

Breztri Aerosphere has already been approved in Japan and China. While the FDA rejection in the past gave GSK's Trelegy Ellipta a head start in the US market, the recent clinical trial successes are expected to help Breztri Aerosphere gain ground. The drug's performance in reducing exacerbations and its approval in key markets will be pivotal in its financial success[4].

Cost and Accessibility

The cost of Breztri Aerosphere can vary based on insurance plans and other factors. As a brand-name drug, it is currently more expensive due to the extensive research and development costs involved. However, once the patent expires, the potential for generic versions could lead to lower costs for patients[5].

Competitive Landscape

AstraZeneca and GSK have been competitors in the respiratory market for some time. While Trelegy Ellipta has an established presence, Breztri Aerosphere's clinical data and AstraZeneca's marketing prowess are expected to make it a strong contender. The competition between these two companies will continue to shape the COPD treatment landscape[4].

Future Outlook

AstraZeneca's commitment to innovation in respiratory diseases is evident from its ongoing research and development efforts. The company's collaboration with Amgen on other respiratory and immune-mediated diseases further strengthens its pipeline and portfolio. This broad pipeline and portfolio are crucial for sustaining long-term growth and market dominance[3].

Key Takeaways

• Clinical Success: Breztri Aerosphere has shown significant reductions in COPD exacerbations in clinical trials.
• Market Positioning: AstraZeneca's experience and physician familiarity with Symbicort will drive uptake.
• Financial Trajectory: Anticipated blockbuster sales levels over the next decade.
• Competitive Landscape: Strong competition with GSK's Trelegy Ellipta, but AstraZeneca's marketing and clinical data are advantageous.
• Cost and Accessibility: Currently expensive as a brand-name drug, but potential for lower costs with generic versions in the future.

FAQs

1. What are the active ingredients in Breztri Aerosphere?

   • The active ingredients in Breztri Aerosphere are budesonide, glycopyrrolate, and formoterol fumarate[5].

2. What were the key findings of the ETHOS trial for Breztri Aerosphere?

   • The ETHOS trial showed a 24% reduction in exacerbations over 52 weeks compared to dual-drug combination therapies[1][4].

3. How does Breztri Aerosphere compare to GSK's Trelegy Ellipta?

   • While Trelegy Ellipta has an established presence, Breztri Aerosphere's clinical data and AstraZeneca's marketing experience are expected to make it a strong competitor[4].

4. What is the current market approval status of Breztri Aerosphere?

   • Breztri Aerosphere is approved in Japan and China, with anticipated approvals in the EU and US based on recent clinical trial successes[1][4].

5. How can patients reduce the cost of Breztri Aerosphere?

   • Patients can lower the cost through insurance plans, coupons, and potentially generic versions once the patent expires[5].

Sources

1. Clinical Trials Arena: AstraZeneca's Breztri Aerosphere is a late-stage blockbuster.
2. AstraZeneca: Full year and Q4 2022 results.
3. AstraZeneca: AstraZeneca unveils latest research across key respiratory and immune-mediated diseases at ATS 2024.
4. FiercePharma: AstraZeneca touts triplet inhaler Breztri's COPD win ahead of key FDA decision.
5. Medical News Today: Breztri Aerosphere cost 2024: Coupons and more.