Formoterol fumarate; glycopyrrolate - Generic Drug Details

What are the generic sources for formoterol fumarate; glycopyrrolate and what is the scope of patent protection?

Formoterol fumarate; glycopyrrolate is the generic ingredient in one branded drug marketed by Astrazeneca and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Formoterol fumarate; glycopyrrolate has one hundred and ninety-two patent family members in thirty-two countries.

One supplier is listed for this compound.

Summary for formoterol fumarate; glycopyrrolate

International Patents:	192
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	5
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for formoterol fumarate; glycopyrrolate
DailyMed Link:	formoterol fumarate; glycopyrrolate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for formoterol fumarate; glycopyrrolate

Constraining patent/regulatory exclusivity:

8,324,266

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 formoterol fumarate; glycopyrrolate

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

Sponsor	Phase
University of Alabama at Birmingham	PHASE2
Chiesi Farmaceutici S.p.A.	Phase 3
Pearl Therapeutics, Inc.	Phase 3

See all formoterol fumarate; glycopyrrolate clinical trials

Pharmacology for formoterol fumarate; glycopyrrolate

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

Anatomical Therapeutic Chemical (ATC) Classes for formoterol fumarate; glycopyrrolate

R03AC	Selective beta-2-adrenoreceptor agonists
R03A	ADRENERGICS, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

R03CC	Selective beta-2-adrenoreceptor agonists
R03C	ADRENERGICS FOR SYSTEMIC USE
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

US Patents and Regulatory Information for formoterol fumarate; glycopyrrolate

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	8,808,713		Y
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	9,415,009
Astrazeneca	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294-001	Apr 25, 2016		RX	Yes	Yes	9,463,161		Y
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	8,815,258
Astrazeneca	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294-001	Apr 25, 2016		RX	Yes	Yes	10,716,753		Y

International Patents for formoterol fumarate; glycopyrrolate

Country	Patent Number	Title	Estimated Expiration
Mexico	350164
Taiwan	I633898
Russian Federation	2011154148
European Patent Office	2435025
Taiwan	201109049
Australia	2010253950
Israel	216466

Supplementary Protection Certificates for formoterol fumarate; glycopyrrolate

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	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
2435024	21C1020	France		PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI), GLYCOPYRROLATE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET BUDESONIDE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); REGISTRATION NO/DATE: EU/1/20/1498 20201210
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
2435024	15/2021	Austria		PRODUCT NAME: FORMOTEROLFUMARAT-DIHYDRAT / GLYCOPYRRONIUMBROMID / BUDESONID; REGISTRATION NO/DATE: EU/1/20/1498 (MITTEILUNG) 20201210
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

Market Dynamics and Financial Trajectory for Formoterol Fumarate and Glycopyrrolate

Last updated: November 24, 2025

Introduction

The pharmaceutical landscape for respiratory and cholinergic agents has witnessed significant evolution, driven by advancements in drug formulation, increased prevalence of chronic respiratory conditions, and demand for targeted therapies. Key among these agents are Formoterol Fumarate, a long-acting beta-agonist (LABA), and Glycopyrrolate, an anticholinergic used in both inhalation and other therapeutic modalities. Understanding their market dynamics and financial trajectory provides critical insights for industry stakeholders, investors, and healthcare providers.

Market Overview of Formoterol Fumarate

Therapeutic Application and Market Penetration

Formoterol fumarate primarily addresses asthma and Chronic Obstructive Pulmonary Disease (COPD). Its rapid onset combined with long-acting duration makes it suitable for maintenance therapy. The global COPD drugs market was valued at approximately $14 billion in 2022[1], with inhaled bronchodilators constituting a significant share.

Leading pharmaceutical companies such as AstraZeneca, Teva, and Novartis hold patents and marketing rights for formulations containing Formoterol. The market's growth is propelled by increasing diagnoses of asthma and COPD, especially in aging populations, and the rising prevalence of environmental and smoking-related respiratory conditions.

Market Drivers

• Rising prevalence of COPD and asthma globally, with WHO estimating over 200 million asthma sufferers and 250 million COPD cases worldwide[2].

• Improved inhaler delivery systems (e.g., dry powder inhalers) enhancing patient compliance.

• The expansion of combination inhalers integrating Formoterol with corticosteroids (e.g., Formoterol/budesonide), which are increasingly favored in clinical guidelines.

• Regulatory approvals for new indications and formulations, including once-daily dosing options, extend patent life and provide revenue growth opportunities.

Market Challenges

• Patent expirations for some formulations threaten generic competition, impacting profit margins.

• Competition from other long-acting bronchodilators like Salmeterol and Tiotropium presents pricing and market share challenges.

• Stringent inhaler device regulations and the need for demonstrable long-term safety data.

Financial Trajectory

Forecasts indicate a compound annual growth rate (CAGR) of 4-6% for the Formoterol segment until 2030[3]. Revenue streams are diversified across regions, with North America and Europe accounting for nearly 70% of global sales**, driven by high disease prevalence and healthcare expenditure.

Market leaders are investing in biosimilar formulations and combination therapies, seeking to extend patent protections and capture larger market shares.

Market Overview of Glycopyrrolate

Therapeutic Application and Market Penetration

Glycopyrrolate is a versatile anticholinergic agent used for:

• Chronic COPD management
• Preoperative reduction of salivary secretions
• Incontinence treatments in urology (e.g., glycopyrrolate transdermal patches)

Its inhalation formulation, particularly marketed as Glycopyrrolate inhalation solution, has gained approval in several jurisdictions for COPD treatment, often as a competitor or complement to other anticholinergics such as Tiotropium and Ipratropium.

Market Drivers

• An aging demographic with higher COPD and post-surgical needs.

• Efficacy in reducing exacerbations and improving lung function demonstrated in clinical trials[4].

• Regulatory approvals for innovative delivery systems, including nebulized solutions and long-acting inhalers.

• Increasing adoption of dual therapy regimens, pairing Glycopyrrolate with other bronchodilators for enhanced symptom control.

Market Challenges

• Patent cliffs and rising availability of generic formulations.

• Competition from established anticholinergics with entrenched market positions.

• Potential safety concerns related to extrapulmonary anticholinergic effects necessitating monitoring.

Financial Trajectory

The market for Glycopyrrolate in respiratory indications is projected to grow at a CAGR of approximately 3-5% through 2030[5]. Revenue growth depends heavily on regional regulatory approvals, the uptake of innovative formulations, and clinical guidelines favoring Glycopyrrolate-based therapies.

Additionally, expanding indications—such as use in urology—open new revenue streams. Companies investing in sustained-release creams and patches are likely to influence market dynamics positively.

Synergistic Market Dynamics

Both Formoterol Fumarate and Glycopyrrolate serve crucial roles in COPD management, with their combination therapy gaining prominence. Market trends favor the development and approval of fixed-dose combination inhalers, which enhance adherence and clinical outcomes.

• Combination therapies (e.g., Formoterol plus Glycopyrrolate) classified as LABA/LAMA (Long-Acting Beta-Agonist/Long-Acting Muscarinic Antagonist), are anticipated to command premium pricing and higher market share, especially in advanced COPD stages.

• Regulatory agencies are increasingly endorsing the complementary use of these agents, fostering synergistic growth.

Investment and Business Opportunities

The current trajectory indicates robust growth potential, driven by:

• Pipeline expansion: Novel formulations, fixed-dose combinations, and delivery systems.

• Emerging markets: Countries like China, India, and Brazil are experiencing rising demand due to increasing prevalence and healthcare investments.

• Strategic partnerships: Licensing agreements, co-development initiatives, and acquisitions aim to extend patent protections and expand portfolios.

• Generics and biosimilars: The impending patent expiries open avenues for generic entrants to capture market share, pressing brand-name players to innovate.

Regulatory and Competitive Landscape

Regulatory bodies such as the FDA and EMA are streamlining approval pathways for inhaled therapies, facilitating faster market entry for new formulations. However, rigorous safety and efficacy data remain prerequisites.

Competitive advantage hinges on:

• Enhanced delivery devices that improve drug deposition and patient adherence.

• Cost-effective manufacturing to compete on price amidst rising generic competition.

• Strong clinical evidence demonstrating superior efficacy and safety profiles.

Key Takeaways

• The global market for Formoterol Fumarate, driven by COPD and asthma prevalence, remains on a steady growth path with a CAGR of approximately 4-6%. Innovation in formulations and combination therapies are central to sustaining revenue streams.

• Glycopyrrolate’s market growth, estimated at 3-5%, benefits from expanding indications, improved delivery systems, and emerging markets. Competition is intense, necessitating focus on differentiation and clinical validation.

• Both agents are increasingly integrated into combination inhalers, with LABA/LAMA formulations expected to dominate future COPD treatment paradigms.

• Patent expiries and rising generic competition emphasize the importance of innovation, strategic collaborations, and cost management for sustained financial performance.

• The regional and regulatory landscape significantly influences growth trajectories. Emerging markets offer substantial opportunities due to demographic shifts and growth in healthcare infrastructure.

Conclusion

The future financial trajectory for Formoterol Fumarate and Glycopyrrolate hinges on innovation, regulatory strategy, and market penetration. Stakeholders should prioritize developing combination therapies, enhancing delivery devices, and exploring expanding indications. Monitoring patent landscapes and regional market dynamics will be imperative to optimize profitability and maintain competitive advantages.

References

[1] MarketWatch. "Global COPD Drugs Market Size, Share & Trends Analysis Report." 2022.

[2] World Health Organization. "Global Surveillance, Prevention and Control of Chronic Respiratory Diseases." 2021.

[3] Grand View Research. "Inhaled Bronchodilators Market Size & Trends." 2022.

[4] Johnson M., et al. "Efficacy of Glycopyrrolate in COPD Management." Respiratory Medicine, 2021.

[5] IQVIA Institute. "The Global Use of Medicines in COPD," 2022.