Budesonide; formoterol fumarate dihydrate - Generic Drug Details

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

Budesonide; formoterol fumarate dihydrate is the generic ingredient in two branded drugs marketed by Mylan and Astrazeneca, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Four suppliers are listed for this compound.

Summary for budesonide; formoterol fumarate dihydrate

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	4
Clinical Trials:	11
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for budesonide; formoterol fumarate dihydrate
DailyMed Link:	budesonide; formoterol fumarate dihydrate at DailyMed

Recent Clinical Trials for budesonide; formoterol fumarate dihydrate

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

Sponsor	Phase
Cipla Ltd.	Phase 3
Actavis Inc.	Phase 3
Teva Pharmaceuticals USA	Phase 3

See all budesonide; formoterol fumarate dihydrate clinical trials

Pharmacology for budesonide; formoterol fumarate dihydrate

Drug Class	Corticosteroid beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for budesonide; formoterol fumarate dihydrate

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

Paragraph IV (Patent) Challenges for BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SYMBICORT	Metered Inhalation	budesonide; formoterol fumarate dihydrate	80 mcg/4.5 mcg per inhalation and 160 mcg/4.5 mcg per inhalation	021929	1	2018-06-26

US Patents and Regulatory Information for budesonide; formoterol fumarate dihydrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan	BREYNA	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	211699-002	Mar 15, 2022	AB	RX	No	No
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-001	Jul 21, 2006	AB	RX	Yes	Yes
Mylan	BREYNA	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	211699-001	Mar 15, 2022	AB	RX	No	No
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-002	Jul 21, 2006	AB	RX	Yes	Yes

Expired US Patents for budesonide; formoterol fumarate dihydrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-002	Jul 21, 2006	7,897,646*PED
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-002	Jul 21, 2006	7,367,333*PED
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-001	Jul 21, 2006	7,759,328*PED
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-002	Jul 21, 2006	8,143,239*PED
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-002	Jul 21, 2006	6,123,924*PED

EU/EMA Drug Approvals for budesonide; formoterol fumarate dihydrate

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Teva Pharma B.V.	Budesonide/Formoterol Teva Pharma B.V.	budesonide, formoterol fumarate dihydrate	EMEA/H/C/004882Budesonide/Formoterol Teva Pharma B.V. is indicated in adults 18 years of age and older only.AsthmaBudesonide/Formoterol Teva Pharma B.V. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate:-in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.or-in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.COPDSymptomatic treatment of patients with COPD with forced expiratory volume in 1 second (FEV1)	Authorised	no	no	no	2020-04-03
Teva Pharma B.V.	Budesonide/Formoterol Teva Pharma B.V.	budesonide, formoterol fumarate dihydrate	EMEA/H/C/003953Budesonide/Formoterol Teva Pharma B.V. is indicated in adults 18 years of age and older only.AsthmaBudesonide/Formoterol Teva Pharma B.V. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate: orin patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.	Withdrawn	no	no	no	2014-11-19

Market Dynamics and Financial Trajectory for Budesonide; Formoterol Fumarate Dihydrate

Last updated: July 30, 2025

Introduction

Budesonide; Formoterol Fumarate Dihydrate represents a significant combination therapy in the respiratory pharmaceuticals market, primarily targeting conditions such as asthma and chronic obstructive pulmonary disease (COPD). Its dual-action profile—combining corticosteroid and long-acting beta-agonist components—addresses both inflammation and bronchoconstriction, providing comprehensive disease management. As the global respiratory disease burden rises, understanding the market dynamics and financial trajectory of this drug combination is critical for stakeholders ranging from pharmaceutical companies to investors.

Market Overview

The pharmaceutical landscape for respiratory therapies, particularly inhaled corticosteroid (ICS) and long-acting beta-agonist (LABA) combinations, has seen exponential growth. This trend is driven by the increasing prevalence of asthma and COPD worldwide, aging populations, and advancements in inhalation device technology. Budesonide combined with Formoterol Fumarate Dihydrate has established itself as a key player due to its proven efficacy, safety profile, and convenient dosing regimens.

Global sales of combination inhalers like Budesonide/Formoterol are projected to grow at a compound annual growth rate (CAGR) of approximately 4.5% through 2028, according to recent market research reports. Factors fueling this growth include improving diagnosis rates, expanding access in emerging markets, and growing awareness of optimal respiratory health management.

Current Market Share and Leading Regions

North America remains the largest market, driven by high prevalence, robust healthcare infrastructure, and well-established reimbursement frameworks. The United States accounts for over 45% of global sales, with key players such as AstraZeneca and Teva leading the commercial landscape.

Europe presents a mature yet expanding market, particularly in the UK, Germany, and France, with increased adoption of combination therapies aligned with updated clinical guidelines.

Emerging regions such as Asia-Pacific (APAC) and Latin America are witnessing rapid growth, attributed to rising disease awareness, increasing healthcare expenditure, and expanding pharmaceutical distribution channels. In APAC, countries like China and India are expected to be major contributors to future revenue, given their large patient populations and evolving healthcare systems.

Market Drivers

Growing Disease Burden

The World Health Organization (WHO) estimates over 339 million people suffer from asthma globally, with COPD affecting more than 200 million individuals. These chronic respiratory conditions necessitate long-term management, boosting demand for inhaled combination therapies like Budesonide/Formoterol.

Advancements in Inhaler Technology

The advent of dry powder inhalers (DPIs) and pressurized metered-dose inhalers (pMDIs) with improved drug delivery mechanisms has increased adherence and treatment efficacy, encouraging prescribers to recommend combination products.

Regulatory Approvals and Clinical Evidence

Regulatory agencies such as the FDA and EMA have approved multiple formulations of Budesonide; Formoterol Fumarate Dihydrate, validating its safety and efficacy. Ongoing clinical trials reinforcing its therapeutic benefits further support market growth.

Expanding Access and Reimbursement

In numerous developing economies, increasing healthcare coverage and reimbursement policies facilitate broader patient access, accelerating sales.

Patent Expirations and Generic Entry

While patented formulations command premium pricing, impending patent expirations in select markets are expected to catalyze generic entry, fostering price competition and potentially expanding market size.

Competitive Landscape

Major pharmaceutical entities involved in this space include AstraZeneca (Symbicort), Teva Pharmaceuticals, and Mylan. AstraZeneca, with its flagship Symbicort brand, dominates a significant market share, leveraging extensive R&D, marketing, and distribution networks.

Generic manufacturers are increasingly introducing biosimilar and generic versions post-patent expiry, intensifying competition, reducing prices, and widening access.

Financial Trajectory and Revenue Projections

Revenue Trends

Based on historical sales data, the revenue generated by Budesonide; Formoterol Fumarate Dihydrate products across global markets has surpassed USD 3 billion annually, with steady incremental growth observed in recent years.

From 2020 to 2022, the compound annual growth rate approached 4%, aligning with broader respiratory drug market trends. The launch of new formulations and expanded indications could accelerate this trajectory.

Pricing Dynamics

Pricing strategies vary geographically: North America maintains premium pricing, whereas emerging markets often see significantly lower costs owing to regulatory and economic factors. The entry of biosimilars could reshape pricing landscape, potentially reducing patient costs and increasing volume sales.

Forecast for 2023–2028

Analysts project that total sales for Budesonide; Formoterol Fumarate Dihydrate could reach USD 4.5–5 billion by 2028, driven by market expansion in APAC and increased adoption in COPD management protocols. Compound annual growth rate (CAGR) estimates hover around 4-5%, factoring in patent expiries, pipeline developments, and evolving treatment guidelines.

Regulatory and Patent Landscape

Patent protections for key formulations are set to expire between 2024 and 2026 in select jurisdictions, opening avenues for generic competitors. Regulatory hurdles are minimal given existing approvals, but manufacturing standards and inhaler device approvals remain critical considerations for new entrants.

Regulatory agencies are increasingly prioritizing bioequivalence and device safety, potentially streamlining approval processes for generics and biosimilars. This trend could enhance competition but also pressure previously dominant brand sales.

Future Market Opportunities and Challenges

Opportunities

• Emerging Markets: Increasing healthcare investments, urbanization, and rising respiratory disease prevalence offer vast growth potential.

• Innovative Delivery Techniques: Development of smarter inhalers with digital connectivity can improve adherence and enable personalized treatment plans.

• Expanded Indications: Investigating additional respiratory conditions or combination therapies could further extend market reach.

Challenges

• Pricing Pressure and Reimbursement Policies: Governments and payers are seeking cost containment, potentially limiting profit margins.

• Generic Competition: Patent expiry in key markets can lead to commoditization, affecting pricing and revenues.

• Adherence and Patient Education: Ensuring proper inhaler technique remains a challenge, impacting drug efficacy and market penetration.

Conclusion

The market for Budesonide; Formoterol Fumarate Dihydrate is poised for steady growth driven by rising respiratory disease prevalence, technological advances, and expanding access in emerging markets. While patent expiries and competitive pressures pose challenges, strategic innovation and market diversification offer paths for sustained financial performance.

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Key Takeaways

• Global sales of Budesonide; Formoterol Fumarate Dihydrate are expected to reach USD 4.5–5 billion by 2028, with a CAGR of around 4-5%.

• North America dominates the market, but Asia-Pacific and Latin America present significant growth opportunities due to their expanding patient populations and healthcare infrastructure.

• Patent expiries in upcoming years will likely catalyze generic entry, leading to decreased prices but expanded market access.

• Innovations in inhaler technology and digital health integration are expected to enhance patient adherence and treatment outcomes.

• Competitive strategies should focus on entering emerging markets, investing in R&D for next-generation formulations, and engaging in partnerships to navigate regulatory landscapes effectively.

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FAQs

1. When are key patents for Budesonide; Formoterol Fumarate Dihydrate set to expire?
Patent protection varies by region but generally expires between 2024 and 2026, with some formulations and regions experiencing extensions or pediatric exclusivities.

2. How are generic versions impacting the market?
Generic entrants are expected to introduce lower-cost alternatives post-patent expiry, intensifying price competition and potentially increasing overall market volume.

3. What are the primary therapeutic advantages of Budesonide; Formoterol Fumarate Dihydrate?
The combination offers both anti-inflammatory effects via corticosteroids and bronchodilation via long-acting beta-agonists, leading to improved symptom control and reduced exacerbations.

4. Which emerging markets are most promising for growth?
China, India, Brazil, and Southeast Asian nations offer substantial growth potential due to increasing respiratory disease prevalence and improving healthcare infrastructure.

5. What technological advancements could influence future sales?
Smart inhalers with digital monitoring, personalized dosing, and adherence tracking are poised to revolutionize treatment effectiveness and market dynamics.

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Sources:
[1] Global Market Insights. "Inhaler Devices Market Size & Trends." 2022.
[2] WHO. "Global Surveillance, Prevention and Control of Chronic Respiratory Diseases." 2021.
[3] IMS Health Data & Analytics. "Respiratory Drugs Market Report." 2022.