BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE - Generic Drug Details

What are the generic drug sources for budesonide; formoterol fumarate; glycopyrrolate and what is the scope of freedom to operate?

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

Budesonide; formoterol fumarate; glycopyrrolate has two hundred and sixteen patent family members in thirty-four countries.

One supplier is listed for this compound.

Summary for BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE

International Patents:	216
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE
DailyMed Link:	BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE

Constraining patent/regulatory exclusivity:

8,703,806

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.

Pharmacology for BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE

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

Anatomical Therapeutic Chemical (ATC) Classes for BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE

A07EA	Corticosteroids acting locally
A07E	INTESTINAL ANTIINFLAMMATORY AGENTS
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

D07AB	Corticosteroids, moderately potent (group II)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

D07AC	Corticosteroids, potent (group III)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

R01AD	Corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

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

R03BA	Glucocorticoids
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, 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

S01BA	Corticosteroids, plain
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for BUDESONIDE; 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 Ab	BREZTRI AEROSPHERE	budesonide; formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	212122-001	Jul 23, 2020		RX	Yes	Yes	10,716,753		Y
Astrazeneca Ab	BREZTRI AEROSPHERE	budesonide; formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	212122-001	Jul 23, 2020		RX	Yes	Yes	8,703,806
Astrazeneca Ab	BREZTRI AEROSPHERE	budesonide; formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	212122-001	Jul 23, 2020		RX	Yes	Yes	11,331,442		Y
Astrazeneca Ab	BREZTRI AEROSPHERE	budesonide; formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	212122-001	Jul 23, 2020		RX	Yes	Yes	8,808,713		Y

International Patents for BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE

Country	Patent Number	Title	Estimated Expiration
Croatia	P20200260
Canada	2763936	COMPOSITIONS PERMETTANT L'ADMINISTRATION DE PRINCIPES ACTIFS PAR VOIE RESPIRATOIRE ET METHODES ET SYSTEMES ASSOCIES (COMPOSITIONS FOR RESPIRATORY DELIVERY OF ACTIVE AGENTS AND ASSOCIATED METHODS AND SYSTEMS)
Israel	216468	תרכובות פרמצבטיות למתן באמצעות משאף מינוני המכילות גליקופירולט ופורמוטרול ושמושן לטיפול במחלות נשימתיות (Pharmaceutical compositions deliverable from a metered dose inhaler comprising glycopyrrolate and formoterol and their use in treatment of pulmonary diseases)
Lithuania	C2435024

Supplementary Protection Certificates for BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435025	LUC00124	Luxembourg		PRODUCT NAME: UNE COMBINAISON DE GLYCOPYRROLATE (Y COMPRIS SES SELS, ESTERS, ENANTIOMERES OU AUTRES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, ENANTIOMERES OU AUTRES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/18/1339 20181220
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	300995	Netherlands		PRODUCT NAME: COMBINATIE VAN GLYCOPYRRONIUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER, IN HET BIJZONDER GLYCOPYRRONIUYM BROMIDE, EN FORMOTEROL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER, IN HET BIJZONDER FORMOTEROL FUMARAAT DIHYDRAAT; REGISTRATION NO/DATE: EU/ 1/18/1339 20181220
2435024	2190014-7	Sweden		PRODUCT NAME: A COMBINATION OF FORMOTEROL INCLUDING ANY PHARMACEUUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, GLYCOPYRROLATE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, AND BUDESONIDE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALT, ESTERS ORSOLVATES THEREOF; REG. NO/DATE: EU/1/20/1498 20201210

Market Dynamics and Financial Trajectory for BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE

Last updated: November 24, 2025

Introduction

The combination of BUDESONIDE, FORMOTEROL FUMARATE, and GLYCOPYRROLATE constitutes a significant therapeutic class targeting respiratory diseases, primarily chronic obstructive pulmonary disease (COPD) and asthma. This triad represents an innovative approach to inhaled therapy, aiming to optimize disease control through combination pharmacotherapy. This report examines the current market landscape, evolving dynamics, regulatory climate, and financial outlook for these drugs, providing stakeholders with a comprehensive understanding of their trajectory.

---

Market Landscape and Growth Drivers

Therapeutic Market Overview

Respiratory diseases, notably COPD and asthma, represent a substantial and expanding global health burden. According to the World Health Organization (WHO), COPD is projected to become the third leading cause of mortality worldwide by 2030, with an increasing prevalence driven by aging populations and environmental exposures (1). The global respiratory drug market was valued at approximately USD 19 billion in 2022 and is expected to witness a CAGR of around 6% through 2028 (2).

Mechanism of Action and Therapeutic Advantages

• Budesonide: An inhaled corticosteroid (ICS) that mitigates airway inflammation.
• Formoterol fumarate: A long-acting beta-agonist (LABA) providing bronchodilation.
• Glycopyrrolate: A long-acting muscarinic antagonist (LAMA) offering sustained airway smooth muscle relaxation.

The fixed-dose combination enhances adherence, reduces exacerbations, and improves lung function profiles, which are critical endpoints in respiratory therapy. Trials show that combination inhalers tend to outperform monotherapy in reducing hospitalizations and improving quality of life (3).

---

Market Dynamics

1. Regulatory and Approval Landscape

The regulatory environment significantly influences market growth. The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accelerated approvals for combination inhalers due to their clinical benefits. Recently, several formulations containing these constituents have received approvals, reflecting confidence in their safety and efficacy profiles.

2. Patent Expirations and Generic Competition

Patent expiration historically catalyzes generics' entry, impacting pricing and market share. For example, GSK’s Fluticasone/Formoterol products have faced biosimilar competition since 2020, exerting downward pressure on prices (4). The market for BUDESONIDE-based combinations could face similar challenges post patent expiry, necessitating innovation to maintain competitive advantage.

3. Competitive Landscape

Major players include GSK, AstraZeneca, and Teva Pharmaceuticals. GSK’s Relvar Ellipta (fluticasone/vilanterol) pioneered combination inhalers, setting market standards. The introduction of BUDESONIDE/formoterol formulations, such as AstraZeneca’s Symbicort, intensified competition. Emerging players, possibly through biosimilar development, threaten to erode market share and margins.

4. Market Penetration and Adoption Rates

Adoption hinges on physician prescribing habits, patient compliance, and formulary inclusion. Increasing awareness of combination therapy benefits has accelerated adoption, especially in moderate to severe COPD cases. Regional disparities exist, with North America and Europe leading in market penetration due to advanced healthcare infrastructure and reimbursement frameworks.

---

Financial Trajectory and Revenue Forecast

Current Revenue Status

The respiratory combination segment generated an estimated USD 8 billion in worldwide sales in 2022, with BUDESONIDE-based formulations accounting for approximately USD 2.5 billion. GSK’s Pulmicort and AstraZeneca’s Symbicort dominate this segment, with robust sales figures (2).

Forecasted Growth and Revenue Projections

Analysts project a healthy CAGR of approximately 5.5-6% for this segment over the next five years, reaching around USD 14 billion by 2028. Factors contributing to growth include:

• Increased prevalence of COPD and asthma.
• Enhanced drug formulations with improved delivery mechanisms.
• Expanding indications and off-label uses.
• Market expansion into emerging economies, notably China, India, and Latin America, where respiratory diseases are rapidly rising.

Impact of Innovation and Pipeline Developments

Development pipelines focusing on inhalers that combine corticosteroids, LABAs, and LAMAs remain promising. The launch of next-generation formulations, such as once-daily inhalers with minimal side effects, could expand market size. Companies investing in biologics and personalized medicine may also influence the trajectory, creating high-value, targeted therapies.

---

Market Challenges and Risks

• Pricing pressure due to patent expiries and biosimilar proliferation.
• Regulatory hurdles in emerging markets requiring localized clinical data.
• Patient adherence issues related to inhaler technique and device complexity.
• Environmental regulations aiming to phase out inhalers with hydrofluorocarbon propellants, impacting device design and manufacturing costs.

---

Regulatory and Policy Considerations

Government-led initiatives to reduce healthcare costs and promote inhaler device reuse are noteworthy. The increasing emphasis on environmentally sustainable inhalers may influence product design and application strategies. Furthermore, regulatory bodies are increasingly favoring digital health integrations, such as inhaler tracking, to improve adherence and pharmacovigilance.

---

Strategic Implications for Industry Stakeholders

• Pharmaceutical companies should innovate through combination formulations with improved delivery systems and reduced side effects.
• Manufacturers must navigate patent landscapes prudently and prepare for biosimilar entry.
• Investors should focus on companies with strong pipelines, regulatory approvals, and presence in emerging markets.
• Healthcare providers should advocate for therapies proven to reduce exacerbations and hospitalizations, aligning market offerings accordingly.

---

Key Takeaways

• The respiratory combination drug market, led by BUDESONIDE, FORMOTEROL FUMARATE, and GLYCOPYRROLATE, is poised for steady growth driven by rising disease prevalence and technological innovation.
• Patent expirations and biosimilar development remain key risks, emphasizing the need for ongoing innovation and strategic positioning.
• Regulatory support and environmental sustainability initiatives will shape product development and market access strategies.
• Expanding into emerging markets offers significant growth opportunities due to increasing disease burden and improving healthcare infrastructure.
• Stakeholders investing in this segment should monitor pipeline developments, regulatory trends, and regional market entry conditions to optimize financial performance.

---

FAQs

Q1: How does the combination of BUDESONIDE, FORMOTEROL FUMARATE, and GLYCOPYRROLATE improve patient outcomes?
A1: By targeting inflammation (Budesonide), airway relaxation (Formoterol), and airway constriction (Glycopyrrolate), the combination enhances bronchodilation, reduces exacerbations, and improves lung function more effectively than monotherapies.

Q2: What are the main barriers to market expansion for these drugs?
A2: Barriers include patent protections, high development costs, complex regulatory approval processes in emerging markets, device usability issues, and environmental regulations impacting inhaler formulations.

Q3: How will patent expiries influence future revenues?
A3: Patent expiries will likely introduce generics and biosimilars, reducing prices and margins, though early innovation and pipeline diversification can mitigate revenue loss.

Q4: Which regions present the best growth opportunities?
A4: Emerging markets, notably China, India, and Latin America, due to rising respiratory disease burdens and expanding healthcare access, offer significant growth potential.

Q5: What role does digital health play in the future of respiratory drug market?
A5: Digital inhalers and adherence monitoring tools enhance patient compliance, provide real-time data for clinicians, and create new monetization avenues, shaping future market dynamics.

---

References

1. World Health Organization. (2022). Global surveillance, prevention and control of chronic respiratory diseases.
2. Grand View Research. (2023). Respiratory Drugs Market Size, Share & Trends Analysis.
3. Megerditchian, A., & Boushey, H. A. (2019). Combination Therapy in Asthma and COPD: Benefits and Challenges. Journal of Respiratory Medicine.
4. GSK Annual Report. (2022). Innovations in Respiratory Care.

---

Disclaimer: The figures and projections are estimates based on current market data and trends as of 2023. Continuous developments in drug discovery, patent law, and healthcare policies may alter these trajectories.