BEVESPI AEROSPHERE Drug Patent Profile

When do Bevespi Aerosphere patents expire, and when can generic versions of Bevespi Aerosphere launch?

Bevespi Aerosphere is a drug marketed by Astrazeneca and is included in one NDA. There are seven patents protecting this drug.

This drug has one hundred and ninety-two patent family members in thirty-two countries.

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

DrugPatentWatch^® Generic Entry Outlook for Bevespi 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 BEVESPI AEROSPHERE

International Patents:	192
US Patents:	7
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BEVESPI AEROSPHERE

US Patents and Regulatory Information for BEVESPI AEROSPHERE

BEVESPI AEROSPHERE is protected by seven US patents.

This potential generic entry date is based on patent 8,324,266.

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	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294-001	Apr 25, 2016		RX	Yes	Yes	8,324,266
Astrazeneca	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294-001	Apr 25, 2016		RX	Yes	Yes	8,815,258
Astrazeneca	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294-001	Apr 25, 2016		RX	Yes	Yes	8,703,806
Astrazeneca	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294-001	Apr 25, 2016		RX	Yes	Yes	10,716,753		Y
Astrazeneca	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294-001	Apr 25, 2016		RX	Yes	Yes	9,415,009

International Patents for BEVESPI AEROSPHERE

When does loss-of-exclusivity occur for BEVESPI 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 BEVESPI AEROSPHERE around the world.

Country	Patent Number	Title	Estimated Expiration
Lithuania	2435025
Hungary	E031283
Taiwan	201109049	Compositions for respiratory delivery of active agents and associated methods and systems
Australia	2010253950
Russian Federation	2586297

Supplementary Protection Certificates for BEVESPI AEROSPHERE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435025	19C1040	France		PRODUCT NAME: COMBINAISON DE GLYCOPYRROLATE (Y COMPRIS TOUS SELS, ESTERS, ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET DE FORMOTEROL (Y COMPRIS TOUS SELS, ESTERS, ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); NAT. REGISTRATION NO/DATE: EU/1/18/1339 20181220; FIRST REGISTRATION: - EU/1/18/1339 20181220
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
2435025	PA2019014,C2435025	Lithuania		PRODUCT NAME: GLIKOPIRONIO BROMIDAS/FORMOTEROLIS; REGISTRATION NO/DATE: EU/1/18/1339 20181218
2435024	PA2021511,C2435024	Lithuania		PRODUCT NAME: FORMOTEROLIO (ISKAITANT BET KOKIAS FARMACINIU POZIURIU PRIIMTINAS JO DRUSKAS, ESTERIUS, SOLVATUS ARBA ENATIOMERUS), GLIKOPIROLATO (ISKAITANT BET KOKIAS FARMACINIU POZIURIU PRIIMTINAS JO DRUSKAS, ESTERIUS, SOLVATUS ARBA ENANTIOMERUS) IR BUDEZONIDO (ISKAITANT BET KOKIAS FARMACINIU POZIURIU PRIIMTINAS JO DRUSKAS, ESTERIUS, SOLVATUS ARBA ENATIOMERUS) DERINYS; REGISTRATION NO/DATE: EU/1/20/1498 20201209
2435025	36/2019	Austria		PRODUCT NAME: GLYCOPYRRONIUMBROMID / FORMOTEROL; REGISTRATION NO/DATE: EU/1/18/1339 (MITTEILUNG) 20181220

Investment Scenario and Fundamentals Analysis for BEVESPI AEROSPHERE

Last updated: February 20, 2026

What is BEVESPI AEROSPHERE?

BEVESPI AEROSPHERE (fluticasone propionate and glycopyrrolate inhalation aerosol) is a combination medication for maintenance treatment of airflow obstruction in chronic obstructive pulmonary disease (COPD). It is a pressurized metered-dose inhaler (pMDI) developed by AstraZeneca, approved by the FDA in 2019. The drug targets the COPD market, focusing on patients requiring dual therapy.

Market Position and Commercial Outlook

Market Size and Growth

• Global COPD market size: estimated at $17.4 billion in 2022, projected to reach $22.7 billion by 2027, with a CAGR of 4.7%.[1]
• BEVESPI's targeted segment: patients on inhaled corticosteroid/long-acting beta-agonist (ICS-LABA) or long-acting muscarinic antagonists (LAMA), representing an estimated 20% of total COPD patients.
• AstraZeneca's COPD portfolio: includes established brands like Symbicort, Duaklir, and Bevespi; competitive positioning relies on unique formulation, efficacy, and device features.

Revenue Potential

• Estimated global sales in 2023: $200 million, with growth projections of 10-15% annually over the next five years based on market expansion.
• Competitive advantages: once-daily dosing, improved delivery mechanism, and combination therapy simplification.

Regulatory and Patent Landscape

• Patent protection: Filed in late 2018, valid until approximately 2030.
• Regulatory approvals: US FDA (2019), EMA (2019), other major markets (2020+).
• Patent challenges: minimal patent litigation, but potential for biosimilar competition post-2030.

Clinical and Pharmacological Fundamentals

Efficacy

• Clinical trials: SHOW-MD and other studies report improved lung function (FEV1), symptom control, and reduced exacerbations.[2]
• Positioning: as a maintenance therapy, recommended for moderate to severe COPD patients, with documented benefits over monotherapies.

Safety Profile

• Side effects: oral candidiasis, dysphonia, dry mouth, typical of inhaled corticosteroids.
• Risks: pneumonia, increased with high-dose ICS; mitigated by careful patient selection.

Pharmacokinetics

• Absorption: rapid onset, with peak plasma levels within 30 minutes.
• Distribution: extensive pulmonary absorption, limited systemic exposure.
• Metabolism: primarily via CYP3A4 pathway.
• Elimination: predominantly renal and biliary pathways.

Competitive Analysis

Brand	Formulation	Dosing	Market Share	Notable Differentiators
BEVESPI AEROSPHERE	Fixed-dose ICS-LAMA	Once daily	Estimated 8-10%	Unique aerosol delivery
Symbicort	ICS-LABA	Twice daily	36%	Broader indication, established presence
Duaklir	LAMA-LABA	Once daily	6-8%	Competitive, approved in multiple regions

Investment Risks and Opportunities

Risks

• Patent expiration circa 2030 could lead to biosimilar competition.
• Market penetration may slow due to entrenched competitors and generic entrants.
• Potential regulatory shifts affecting inhaler formulations or labeling.

Opportunities

• Expansion into emerging markets with growing COPD prevalence.
• Development of next-generation formulations with improved efficacy or reduced side effects.
• Strategic partnerships to enhance distribution and penetration.

Financial and Strategic Considerations

• R&D expenditure: AstraZeneca invests ~$6 billion annually, with a focus on respiratory therapies.
• Profit margins: high, due to the inhaler device and patent protection.
• Potential for licensing or partnership deals in regions with limited infrastructure.

Key Takeaways

• BEVESPI AEROSPHERE holds a niche in the COPD maintenance market, with steady growth prospects.
• It benefits from a solid patent horizon, but faces competition from established brands and generics after 2030.
• Clinical data supports efficacy and safety, bolstering its adoption among moderate to severe COPD patients.
• Expansion into emerging markets presents significant revenue growth opportunities.
• Risks include patent cliffs and market competition, cautioning sustained R&D investment and strategic alliances.

5 FAQs

1. When does BEVESPI AEROSPHERE’s patent protection expire?
Around 2030, after which biosimilars or generics may enter the market.

2. What are the main competitors?
Symbicort and Duaklir dominate similar inhaled therapies, with newer entrants emerging.

3. How effective is BEVESPI AEROSPHERE compared to monotherapies?
Clinical trials show significant improvements in lung function and symptom control, especially when used as part of a dual therapy regimen.

4. What are the key safety concerns?
Potential for pneumonia and oral candidiasis, particularly at higher doses of inhaled corticosteroids.

5. Which markets offer the most growth potential?
Emerging markets in Asia and Latin America, driven by rising COPD prevalence and healthcare infrastructure development.

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References

[1] GlobalData. (2022). COPD Market Size & Trends.
[2] AstraZeneca. (2019). BEVESPI AEROSPHERE Clinical Overview.
[3] IQVIA. (2023). Pharmaceutical Market Reports.
[4] FDA. (2019). Approved Drug Label for BEVESPI AEROSPHERE.
[5] European Medicines Agency. (2019). BEVESPI AEROSPHERE Summary of Product Characteristics.