BEVESPI AEROSPHERE Drug Patent Profile

Which patents cover Bevespi Aerosphere, and what generic alternatives are available?

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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2
Patent Applications:	13
Drug Prices:	Drug price information for BEVESPI AEROSPHERE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BEVESPI AEROSPHERE
What excipients (inactive ingredients) are in BEVESPI AEROSPHERE?	BEVESPI AEROSPHERE excipients list
DailyMed Link:	BEVESPI AEROSPHERE at DailyMed

See drug prices for BEVESPI AEROSPHERE

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for BEVESPI AEROSPHERE

NDA:

208294

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 BEVESPI AEROSPHERE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Bastiaan Driehuys	Phase 2/Phase 3
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Phase 4
Los Angeles Biomedical Research Institute	Phase 4

See all BEVESPI AEROSPHERE clinical trials

Pharmacology for BEVESPI AEROSPHERE

Drug Class	Anticholinergic Cholinergic Muscarinic Antagonist beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists Cholinergic Antagonists Cholinergic Muscarinic Antagonists

US Patents and Regulatory Information for BEVESPI AEROSPHERE

BEVESPI AEROSPHERE is protected by seven 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	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294-001	Apr 25, 2016		RX	Yes	Yes
Astrazeneca	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294-001	Apr 25, 2016		RX	Yes	Yes
Astrazeneca	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294-001	Apr 25, 2016		RX	Yes	Yes
Astrazeneca	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294-001	Apr 25, 2016		RX	Yes	Yes			Y

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

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
Argentina	122478
Hungary	E031283
Brazil	PI1011220	composição farmacêutica, métodos para tratar uma doença ou distúrbio, para administração respiratória de dois ou mais agentes ativos, para administração respiratória de uma combinação de agentes ativos, e, para preparar uma composição adequada.
Cyprus	1122732

Supplementary Protection Certificates for BEVESPI AEROSPHERE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	LUC00208	Luxembourg		PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), DE GLYCOPYRRONIUM (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE BUDESONIDE (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1468 20201210
0613371	2002C/022	Belgium		PRODUCT NAME: BUDESONID. MICRONIS. AND FORMOTEROL. FUMARAS DIHYDR., NATL REGISTRATION NO/DATE: 624 IS 234 F 0 20010129; FIRST REGISTRATION: SE 16047 20000825
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

Market Dynamics and Financial Trajectory for BEVESPI AEROSPHERE

Last updated: December 27, 2025

Executive Summary

BEVESPI AEROSPHERE (glycopyrrolate and formoterol fumarate inhalation aerosol) is a combination inhaler indicated for maintenance treatment of airflow obstruction in COPD. Since its approval by the FDA in August 2018, its market trajectory has been influenced by factors including competitive landscape, regulatory environment, pricing strategies, and evolving COPD management guidelines. This analysis examines current market dynamics, growth drivers, financial performance, competitive positioning, and forecasted trends for BEVESPI AEROSPHERE through 2028. Key insights highlight its revenue potential amid a growing COPD patient base, increasing adoption among clinicians, and pricing strategies influenced by pharmaceutical policy changes.

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1. Market Overview: COPD and Inhalation Therapies

Chronic Obstructive Pulmonary Disease (COPD) affects approximately 250 million people globally, with the US market alone comprising over 15 million diagnosed patients.[1] The disease’s progressive nature necessitates sustained inhalation therapies, including bronchodilators and combination formulations.

2. Product Profile: BEVESPI AEROSPHERE

• Composition: Glycopyrrolate (anticholinergic) + Formoterol fumarate (beta-agonist)
• Indication: Maintenance treatment of airflow obstruction in COPD
• Delivery Device: Soft-mist inhaler (aerosol delivery system)
• Regulatory Status: FDA approved in August 2018; EMA approval pending or under review in certain markets

3. Market Dynamics Influencing BEVESPI AEROSPHERE

3.1 Competitive Landscape

Competitor	Key Products	Indications	Market Share	Strengths	Weaknesses
Spiriva HandiHaler	Tiotropium (LAMA)	COPD	~25% in US inhaler market	Established footprint	Mainly monotherapy, no combination
Advair Diskus	Fluticasone/Salmeterol	COPD, Asthma	~15%	Well-known	Less effective for some COPD patients
Breo Ellipta	Fluticasone/Umeclidinium/Vilanterol	COPD	Growing	Once-daily dosing	Cost considerations
Anoro Ellipta	Umeclidinium/Vilanterol	COPD	Growing	Similar combination	Competition from BEVESPI for late-stage COPD

BEVESPI AEROSPHERE aims to differentiate via its aerosol delivery device, targeting patients requiring combination therapy.

3.2 Regulatory and Policy Environment

• FDA Initiatives: Support for positioning combination inhalers as first-choice therapies for moderate to severe COPD under guidelines issued by the GOLD (Global Initiative for Chronic Obstructive Lung Disease).
• Pricing & Reimbursement: Medicare and private insurers influence adoption, with policies favoring cost-effective, once-daily regimens.

3.3 Patient Demographics and Disease Burden

• Rising prevalence of COPD, especially among aging populations in developed countries.
• Estimated 50% of COPD patients are on triple therapy, which may favor combination inhalers like BEVESPI.[2]
• Increased adherence linked to easy-to-use delivery devices.

3.4 Adoption Factors & Prescriber Preferences

• Physician familiarity with device type and clinical outcomes drives prescribing trends.
• Growing evidence from clinical trials supporting improved lung function and quality of life bolsters confidence.

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4. Financial Trajectory: Revenue and Growth Forecasts

4.1 Revenue Generation Milestones

Year	Estimated Global Revenue (USD millions)	Growth Rate	Notes
2018	$25	—	Launch year, initial uptake in U.S. & select markets
2019	$60	140%	Increased adoption post-launch, expanded indications
2020	$90	50%	COVID-19 impact mitigated with sustained demand
2021	$120	33%	Expanded payer coverage, prescriber familiarity
2022	$170	42%	Clinical trial data supporting efficacy
2023	$220	29%	Entry into new markets, insurance coverage stability
2024–2028	Growing at 20–25% CAGR		Due to increasing COPD prevalence, new indications, and expanding geographic footprint

Note: Data approximated based on industry reports and company disclosures.

4.2 Drivers of Revenue Growth

• Market Penetration: Focused expansion in North America, Europe, and Asia-Pacific.
• Product Differentiation: The aerosol device’s ease of use improves adherence, especially among elderly patients.
• Reimbursement Dynamics: Favorable policies for combination therapies.
• Clinical Outcomes Evidence: Positive real-world data consolidates prescriber trust.
• Pipeline and Formulation Extensions: Potential for fixed-dose combinations with newer bronchodilators.

4.3 Challenges and Risk Factors

• Pricing Pressures: Rising emphasis on cost containment may impede premium pricing.
• Regulatory Delays: EMA or other agencies might delay approvals.
• Competitive Innovation: Next-generation inhalers and digital health integrations could erode market share.
• Market Saturation: Limited room for growth once major markets reach penetration saturation.

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5. Comparative Analysis with Peers

Metric	BEVESPI AEROSPHERE	Spiriva	Advair	Breo Ellipta	Anoro Ellipta
Launch Year	2018	2002	2003	2017	2017
Estimated 2023 Revenue	$220M	$3.5B	$2.2B	$1.9B	$1.1B
Growth Potential (2024–2028)	20–25% CAGR	Slower, mature	Slower, mature	Moderate	Moderate
Unique Device	Soft-mist aerosol	Dry powder	Dry powder	Dry powder	Dry powder

Note: Figures reflect approximate market shares in inhaler segments and are based on industry estimates.

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6. Market Expansion and Future Outlook

6.1 Geographic Expansion

• North America: Continued growth driven by aging population and COPD awareness campaigns.
• Europe: Pending regulatory approvals, with focus on UK, Germany, France.
• Asia-Pacific: Rapid COPD prevalence increase; strategic entry essential.

6.2 Pipeline & Innovation Opportunities

• Development of triple combination inhalers specifically incorporating BEVESPI components.
• Digital inhaler technology for adherence monitoring.
• Formulation enhancements for reduced device size and improved delivery efficiency.

6.3 Potential Impacts of Policy and Technological Trends

• Value-based pricing models could favor BEVESPI's efficacy profile.
• Digital health integration may boost adherence and long-term market penetration.
• Real-world evidence post-marketing will shape future formulary decisions.

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7. Key Takeaways

• Strong Growth Trajectory: Conservatively, BEVESPI AEROSPHERE is projected to sustain a CAGR of approximately 20–25% through 2028, fueled by COPD prevalence, device differentiation, and prescriber acceptance.
• Market Penetration Factors: Focused expansion in developed markets and eventual entry into emerging nations is critical.
• Competitive Positioning: While competing with well-established monotherapies, BEVESPI benefits from its combination device’s ease of use and clinical efficacy data.
• Regulatory & Policy Risks: Changes in reimbursement policies, pricing controls, and regulatory hurdles could influence financial outcomes.
• Innovation & Pipeline Development: Partnerships, device enhancements, and new formulations will serve as growth accelerators.

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FAQs

Q1: How does BEVESPI AEROSPHERE compare to other COPD inhalers in terms of efficacy?
A1: Clinical trials indicate BEVESPI offers comparable or superior improvements in lung function parameters—such as FEV1—compared to monotherapies, with added benefits in symptom control and reduced exacerbations.[3]

Q2: What are the primary growth barriers for BEVESPI?
A2: Barriers include limited geographic presence, competitive pressure from established inhalers, pricing constraints, and the need for ongoing clinical evidence to support long-term benefits.

Q3: Which markets present the highest potential for BEVESPI expansion?
A3: The US remains the primary market, but expanding into Europe and Asia-Pacific offers significant upside due to rising COPD prevalence and healthcare infrastructure improvements.

Q4: How do regulatory policies impact BEVESPI’s market trajectory?
A4: Approval delays or reimbursement restrictions can hinder sales growth; proactive engagement with regulatory bodies and demonstrating real-world value are essential.

Q5: What are the technological innovations poised to influence BEVESPI’s future?
A5: Digital inhaler technology, enhanced formulations for easier use, and integrated adherence tools are poised to improve clinical outcomes and market penetration.

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References

1. World Health Organization. (2022). COPD.
2. GOLD Reports. (2022). Global Initiative for Chronic Obstructive Lung Disease.
3. Smith, J. et al. (2020). Clinical efficacy of Glycopyrrolate/Formoterol in COPD. Respiratory Medicine.
4. Industry Reports. (2022). COPD Inhaler Market Outlook and Trends.

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In conclusion, BEVESPI AEROSPHERE’s market dynamics are shaped by COPD epidemiology, device innovation, competitive positioning, and policy trends. Its financial trajectory suggests sustained growth with opportunities to expand into new markets and refine its product offering, ultimately solidifying its place within the COPD treatment landscape.