BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE - Generic Drug Details

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

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.

Five 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:	5
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	211699-001	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
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

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	6,641,800
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-002	Jul 21, 2006	8,575,137*PED
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-002	Jul 21, 2006	5,349,945
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-001	Jul 21, 2006	5,349,945

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: February 20, 2026

What is the Current Market Landscape for BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE?

Budesonide; Formoterol Fumarate Dihydrate is a fixed-dose combination used primarily for asthma and chronic obstructive pulmonary disease (COPD). It combines a corticosteroid (budesonide) with a long-acting beta-agonist (formoterol). Market players include both branded and generic manufacturers.

Key Market Data (2023)

Parameter	Data
Global market size (2023)	$4.9 billion
Compound annual growth rate (CAGR)	4.8%
Major regions	North America (40%), Europe (25%), Asia-Pacific (20%), ROW (15%)
Primary indications	Asthma, COPD
Leading brands	Symbicort (AstraZeneca), Pulmicort (Bayer), generic equivalents

What Factors Drive Market Growth?

Increasing Prevalence of Respiratory Diseases

• Global asthma cases are estimated at 262 million in 2023 [1].
• COPD affects 200 million people worldwide, with increasing incidence in aging populations [2].

Prescribing Trends and Treatment Guidelines

• Fixed-dose inhalers are preferred for adherence.
• Regulatory approvals for generic versions expand access.

Patent Expiry and Generic Entry

• Symbicort's patent expired in the U.S. in 2020.
• Several generics launched in the U.S. and Europe since then.

Innovation and Formulation Developments

• New inhaler devices aim to improve delivery accuracy.
• Combination therapies increasingly become standard first-line treatments.

What Are Revenue Prospects and Financial Trajectories?

Revenue Growth Projections

Year	Projected Market Size	Growth Rate	Notes
2023	$4.9 billion	—	Baseline
2024	$5.2 billion	6.1%	Rise due to increasing prescriptions and new generic options
2025	$5.4 billion	4.0%	Market stabilization as competition intensifies
2026	$5.7 billion	5.5%	Continued expansion in Asia-Pacific, emerging markets

Key Revenue Drivers

• Volume growth in developed markets driven by aging populations.
• Expansion into emerging markets with increasing healthcare infrastructure.
• Price competition from generics, which constrains branded sales but promotes overall market size.

Profitability Considerations

• Branded sales margins: 45-55%.
• Generic entry reduces margins to approximately 20-30%.
• R&D investments focus on innovative delivery systems and adjunct therapies.

How Do Regulatory, Patent, and Competitive Factors Shape the Market?

Patent and Exclusivity Status

• Symbicort's patent expiry influenced market entry.
• No exclusive rights for many generic manufacturers post-expiration.

Regulatory Approvals

• Faster approval pathways in the U.S. (ANDA applications) and Europe.
• Increasing approvals for biosimilar and complex generic formulations.

Competitive Dynamics

• Top competitors include AstraZeneca (Symbicort), Bayer (Pulmicort), and multiple generics.
• Patent litigation and settlements influence market share shifts.

What Is the Future Outlook?

• Compound annual growth rate for the inhaled corticosteroid–long-acting beta-agonist class is expected to remain around 4-5% until 2030.
• Growth will be driven by new formulary placements, updated clinical guidelines, and expanding indications.
• Competition from inhaler device innovations and personalized medicine approaches could alter the trajectory.

Summary of Key Data Points

• Market size: $4.9 billion (2023), projected to reach $5.7 billion ($1.2 billion growth) by 2026.
• Major regions: North America, Europe, Asia-Pacific.
• Growth drivers: rising respiratory disease prevalence, generic entry, treatment guideline shifts.
• Market challenges: patent expirations, pricing pressures, regulatory hurdles.

Key Takeaways

• The market for budesonide; formoterol fumarate dihydrate is mature but growing steadily.
• Generic competition is increasing margins pressure, although volume growth sustains revenue expansion.
• Innovation in inhaler technology and new indications will shape future growth.
• Regulatory and patent landscapes significantly influence market dynamics.
• Strategic focus should include emerging markets and biosimilar development for sustained growth.

FAQs

1. How does patent expiry impact this drug market?

Patent expiry allows generic manufacturers to enter with lower-priced inhalers. This increases market competition, reduces branded drug revenues, and expands overall access, but constrains profit margins for original innovators.

2. Are there significant pipeline developments for this combination?

Pipeline developments focus on inhaler device improvements, combination with other agents (e.g., long-acting muscarinic antagonists), and real-world efficacy studies. No major new molecular entities are currently announced for this specific combination.

3. How does the global prevalence of respiratory diseases influence future sales?

Rising asthma and COPD prevalence, especially in aging populations and emerging markets, will support ongoing demand. Implementation of better diagnosis and treatment access will further drive market size.

4. What role do biosimilars and generics play in this market?

Biosimilars are less relevant due to the inhalation delivery mechanism, but multiple generics of the active ingredients are available. Their entry increases affordability but compresses profitability for original brands.

5. What regional differences affect market dynamics?

North America and Europe lead in market size and innovation adoption. Asia-Pacific exhibits rapid growth due to rising disease prevalence, increasing healthcare coverage, and lower drug prices, leading to differentiated competitive strategies.

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References

[1] Global Initiative for Asthma. (2023). Global asthma statistics. GINA Reports.

[2] World Health Organization. (2020). COPD prevalence and risk factors. WHO Reports.

[3] IQVIA. (2023). Pharmaceutical Market Reports.

[4] Evaluate Pharma. (2023). Market forecast for respiratory therapies.