BEVESPI AEROSPHERE Drug Patent Profile

When do Bevespi Aerosphere patents expire, 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

Constraining patent/regulatory exclusivity:

8,324,266

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
Los Angeles Biomedical Research Institute	Phase 4
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	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.

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
Astrazeneca	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294-001	Apr 25, 2016		RX	Yes	Yes	9,463,161		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
Russian Federation	2020102859	КОМПОЗИЦИИ ДЛЯ ЛЕГОЧНОЙ ДОСТАВКИ АНТАГОНИСТОВ МУСКАРИНОВЫХ РЕЦЕПТОРОВ ДЛИТЕЛЬНОГО ДЕЙСТВИЯ И АГОНИСТОВ B2-АДРЕНЕРГИЧЕСКИХ РЕЦЕПТОРОВ ДЛИТЕЛЬНОГО ДЕЙСТВИЯ И СВЯЗАННЫЕ С НИМИ СПОСОБЫ И СИСТЕМЫ
Philippines	12017500778	COMPOSITIONS, METHODS and SYSTEMS FOR RESPIRATORY DELIVERY OF TWO OR MORE ACTIVE AGENTS
Japan	2018048150	長時間作用性のムスカリン拮抗剤および長時間作用性のΒ２アドレナリン受容体作動剤を肺送達するための組成物ならびに関連の方法および系 (COMPOSITIONS FOR PULMONARY DELIVERY OF LONG-ACTING MUSCARINIC ANTAGONISTS AND LONG-ACTING B2 ADRENERGIC RECEPTOR AGONISTS, AND ASSOCIATED METHODS AND SYSTEMS)
Hungary	E047823
Lithuania	C2435024
Israel	216466	תכשירים לנתינה למערכת הנשימה של גורמים פעילים ושיטות ומערכות קשורות (Compositions for respiratory delivery of active agents and associated methods and systems)

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
2435025	2019026	Norway		PRODUCT NAME: KOMBINASJON AV GLYKOPYRROLAT (INKLUDERT EVENTUELLE FARMASOEYTISK AKSEPTABLE SALTER, ESTERE ELLER ENANTIOMERER DERAV) OG FORMOTEROL (INNBEFATTENDE HVILKE SOM HELST FARMASOEYTISK AKSEPTABLE SALTER, ESTERE ELLER ENANTIOMERER DERAV); REG. NO/DATE: EU/1/18/1339 20190104
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	C02435024/01	Switzerland		PRODUCT NAME: BUDESONID, GLYCOPYRRONIUM UND FORMOTEROL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68388 24.11.2021
2435025	36/2019	Austria		PRODUCT NAME: GLYCOPYRRONIUMBROMID / FORMOTEROL; REGISTRATION NO/DATE: EU/1/18/1339 (MITTEILUNG) 20181220
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

Market Dynamics and Financial Trajectory for BEVESPI AEROSPHERE

Last updated: July 28, 2025

Introduction

BEVESPI AEROSPHERE, a combination inhaled therapy for chronic obstructive pulmonary disease (COPD), has established itself as a significant player within the respiratory pharmaceutical sector. Approved by regulatory authorities such as the FDA and EMA in 2018, this once-daily inhalation therapy combines glycopyrrolate (a long-acting muscarinic antagonist, LAMA) and formoterol fumarate (a long-acting β2-agonist, LABA) in a unique aerosol formulation. As COPD prevalence rises globally, BEVESPI’s market performance and financial outlook are increasingly relevant for stakeholders, including pharmaceutical companies, investors, and healthcare providers.

This analysis explores the market dynamics shaping BEVESPI AEROSPHERE’s trajectory, examines factors influencing its commercial success, and assesses future revenue potential against evolving industry trends.

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1. Market Landscape and Epidemiology

Global COPD Burden

COPD remains a leading cause of morbidity and mortality worldwide. The World Health Organization estimates over 250 million cases globally, with an increasing prevalence fueled by smoking, environmental pollution, and aging populations [1]. North America and Europe are mature markets with high COPD treatment penetration, while emerging markets like Asia-Pacific demonstrate significant growth potential due to rising disease incidence.

Therapeutic Landscape

The COPD treatment paradigm involves inhaled bronchodilators, corticosteroids, and combination therapies. LAMA/LABA combinations, such as BEVESPI, are recommended for maintenance therapy, especially for moderate to severe COPD cases [2].

Key competitors include:

• GlaxoSmithKline’s (GSK) ANORO ELLIPTA (umeclidinium/vilanterol)
• AstraZeneca’s Breztri Aerosphere (budesonide/glycopyrrolate/formoterol)
• Teva’s UTROGESTIN and other emerging combinations

BEVESPI’s differentiation hinges on its proprietary Aerosphere inhalation technology, promising improved drug delivery and efficacy.

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2. Market Dynamics Influencing BEVESPI AEROSPHERE

a. Technological Differentiation and Formulation Advantages

BEVESPI employs Aerosphere technology, a Co-suspension Delivery System that enhances pulmonary deposition and reduces systemic side effects. Clinical trials demonstrate its comparable or superior efficacy relative to existing LAMA/LABA combinations, boosting prescriber confidence and adherence.

b. Prescription Trends and Physician Adoption

Physician prescribing behavior remains crucial. The growing evidence base supporting BEVESPI’s efficacy and tolerability bolsters its uptake. Neuropharmacological benefits, convenience with once-daily dosing, and reduced side effect profile contribute positively to physician preference.

c. Regulatory and Reimbursement Environment

Regulatory approvals by the FDA and EMA facilitate market entry and expansion. Furthermore, positive insurance coverage and reimbursement pathways influence prescribing patterns. Challenges include formulary restrictions and price negotiations that may impact market penetration.

d. Competitive Positioning and Market Share

The COPD market is consolidating, with strategic collaborations and patent portfolios defining competitive dynamics. BEVESPI’s patent protections and technological edge provide a moat, yet competitors’ offerings and biosimilar threats necessitate continuous innovation.

e. Patient Demographics and Compliance

The demographic shift toward an aging population increases COPD patient numbers. The convenience of BEVESPI’s once-daily inhalation favors adherence, a critical factor in long-term management and health economics.

f. Market Expansion and Pipeline Developments

Emerging markets, such as China and India, represent lucrative expansion opportunities, contingent on registration approvals and healthcare infrastructure. Additionally, pipeline developments in triple therapy formulations could pose risks or opportunities depending on their positioning relative to BEVESPI.

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3. Financial Trajectory and Revenue Outlook

a. Revenue Growth Drivers

• Market Penetration: Achieving significant market share through prescriber acceptance and patient adherence.
• Pricing Strategies: Premium positioning based on technology and clinical benefits balanced against competitive pricing pressures.
• Volume Increases: Growth in COPD diagnoses correlates directly with volume expansion.
• Global Expansion: Entry into emerging markets, supported by regulatory approvals and local partnerships.

b. Forecasting Revenue Potential

Based on current prescription trends, analyst projections estimate BEVESPI AEROSPHERE’s revenues could reach USD 400-600 million globally by 2027. This growth depends on:

• Market penetration rate: Targeting 20-30% of approved COPD patients within key markets.
• Pricing models: Maintaining a sustainable premium without limiting accessibility.
• Regulatory approvals: Expanding indications or formulations in additional territories.

c. Challenges and Risks

• Market Competition: Advances from competitors or biosimilars could suppress pricing and share.
• Patent Expirations: Loss of exclusivity could invite generic or biosimilar entries, impacting margins.
• Regulatory Changes: Evolving guidelines may alter reimbursement landscapes.
• Innovation Pace: Failure to innovate or improve formulations could diminish market relevance.

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4. Strategic Considerations and Investment Outlook

Investors should monitor patent statuses, regulatory progress, and adoption rates among pulmonologists. Collaborations with healthcare systems for broader formulary inclusion significantly amplify market reach. As the COPD segment matures, emphasis on real-world evidence and adherence improvements will influence financial outcomes.

Pharmaceutical companies may adopt strategies such as geographic expansion, clinical trial investments to support new indications, or device advancements to sustain competitive advantage.

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Key Takeaways

• Dominant Technology and Differentiation: BEVESPI’s Aerosphere delivery system offers clinical and convenience advantages, supporting sustained market engagement.
• Robust Market Demand: Rising COPD prevalence, especially in aging populations, drives long-term growth potential.
• Competitive Intensity: The market features formidable incumbents with aggressive marketing; differentiation and patent protections are vital.
• Emerging Market Opportunities: Expansion into high-growth regions remains a priority, contingent on regulatory and reimbursement frameworks.
• Financial Outlook: Revenue projections indicate steady growth, with estimated global revenues reaching USD 400-600 million by 2027, assuming successful market penetration and minimal biosimilar impact.

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FAQs

1. How does BEVESPI AEROSPHERE compare to other LAMA/LABA therapies?
BEVESPI’s proprietary Aerosphere technology provides enhanced pulmonary delivery, potentially improving efficacy and reducing side effects. Clinical trials demonstrate comparable or superior outcomes relative to competitors like GSK’s ANORO ELLIPTA, making it a preferred choice for certain patient populations.

2. What are the primary barriers to BEVESPI’s market expansion?
Barriers include intense competition, patent expirations, reimbursement hurdles, and regulatory delays in emerging markets. Additionally, physician familiarity and prescribing habits influence market penetration.

3. What is the impact of patent life on BEVESPI’s financial trajectory?
Patent protections safeguard revenue streams for approximately 10-12 years post-launch. Lapse or challenges could lead to biosimilar competition, compressing margins and market share.

4. How significant is the role of emerging markets in BEVESPI’s growth?
Emerging markets like China present substantial growth opportunities due to rising COPD prevalence. However, success hinges on positive regulatory outcomes and establishing local manufacturing or partnerships.

5. What future innovations could bolster BEVESPI’s competitiveness?
Development of triple-inhaler formulations, improved device ergonomics, and personalized dosing guided by digital health integration could sustain or enhance market relevance.

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References

[1] World Health Organization. “The Global Burden of Disease Study.” 2020.
[2] Global Initiative for Chronic Obstructive Lung Disease (GOLD). “2023 GOLD Reports.”
[3] Company filings and press releases related to BEVESPI AEROSPHERE.
[4] Market research reports on COPD therapeutics, 2022-2023.