BUDESONIDE; FORMOTEROL FUMARATE - Generic Drug Details

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

Budesonide; formoterol fumarate is the generic ingredient in four branded drugs marketed by Astrazeneca, Mylan, and Astrazeneca Ab, and is included in four NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Summary for BUDESONIDE; FORMOTEROL FUMARATE

International Patents:	192
US Patents:	9
Tradenames:	4
Applicants:	3
NDAs:	4
Clinical Trials:	33
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BUDESONIDE; FORMOTEROL FUMARATE
DailyMed Link:	BUDESONIDE; FORMOTEROL FUMARATE at DailyMed

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

Constraining patent/regulatory exclusivity:

10,716,753

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 BUDESONIDE; FORMOTEROL FUMARATE

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

Sponsor	Phase
Parexel	PHASE4
AstraZeneca	PHASE4
AstraZeneca	PHASE3

See all BUDESONIDE; FORMOTEROL FUMARATE clinical trials

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

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

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	9,463,161		Y
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	9,415,009
Astrazeneca Ab	BREZTRI AEROSPHERE	budesonide; formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	212122-001	Jul 23, 2020		RX	Yes	Yes	8,703,806
Astrazeneca	SYMBICORT AEROSPHERE	budesonide; formoterol fumarate	AEROSOL, METERED;INHALATION	216579-001	Apr 28, 2023		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	8,324,266

International Patents for BUDESONIDE; FORMOTEROL FUMARATE

Country	Patent Number	Title	Estimated Expiration
Denmark	3111926
Japan	2019108369	活性剤を呼吸器送達するための組成物、ならびに関連する方法および系 (COMPOSITIONS FOR RESPIRATORY DELIVERY OF ACTIVE AGENTS AND ASSOCIATED METHODS AND SYSTEMS)
Japan	6876734
Portugal	3106149
Spain	2774391
Japan	5873012

Supplementary Protection Certificates for BUDESONIDE; FORMOTEROL FUMARATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435025	PA2019014,C2435025	Lithuania		PRODUCT NAME: GLIKOPIRONIO BROMIDAS/FORMOTEROLIS; REGISTRATION NO/DATE: EU/1/18/1339 20181218
2435024	122021000026	Germany		PRODUCT NAME: GLYCOPYRROLAT MIT FORMOTEROL MIT BUDESONID, ODER SALZE, ESTER, SOLVATE, ENANTIOMERE UND MISCHUNGEN VON ENANTIOMEREN DERSELBEN; REGISTRATION NO/DATE: EU/1/20/1498 20201209
2435024	CR 2021 00014	Denmark		PRODUCT NAME: KOMBINATION AF FORMOTEROL, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, SOLVATER ELLER ENANTIOMERE DERAF, GLYCOPYRROLAT, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, SOLVATER ELLER ENANTIOMERE DERAF, OG BUDESONID, HERUNDER...; REG. NO/DATE: EU/1/20/1498 20201210
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	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
2435025	36/2019	Austria		PRODUCT NAME: GLYCOPYRRONIUMBROMID / FORMOTEROL; REGISTRATION NO/DATE: EU/1/18/1339 (MITTEILUNG) 20181220

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Budesonide; Formoterol Fumarate

Last updated: July 27, 2025

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Introduction

Budesonide; Formoterol Fumarate, a combination therapy primarily used for respiratory conditions such as asthma and Chronic Obstructive Pulmonary Disease (COPD), has seen substantial growth driven by increasing global respiratory disease prevalence. Its unique pharmacological profile as an inhaled corticosteroid combined with a long-acting beta-agonist positions the drug as a preferred treatment option, influencing its market trajectory and financial outlook.

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Pharmacological Profile and Therapeutic Indications

Budesonide; Formoterol Fumarate combines budesonide, an inhaled corticosteroid with anti-inflammatory properties, and formoterol fumarate, a long-acting beta-agonist (LABA) that provides bronchodilation. This fixed-dose combination improves symptom control and reduces exacerbation frequency in chronic respiratory diseases (1).

The primary indications include:

• Moderate to severe asthma.
• COPD management, including exacerbation prevention.

The drug's efficacy, safety profile, and inhaler convenience contribute to its widespread adoption in clinical practice, bolstering market demand.

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Market Dynamics

1. Rising Prevalence of Respiratory Diseases
Global epidemiological data indicate a rising burden of asthma and COPD, driven by urbanization, pollution, smoking rates, and aging populations (2). The World Health Organization estimates approximately 339 million people are affected by asthma, with COPD affecting over 250 million individuals worldwide (3). This increase fuels the demand for effective inhalable therapies, including budesonide; formoterol fumarate.

2. Market Penetration and Product Approvals
Since its introduction, several formulations of budesonide; formoterol fumarate have gained approval across major markets, including the U.S., Europe, and Asia-Pacific. Its approval as both a maintenance and reliever therapy (MART) has expanded usage. The availability of generic versions further intensifies market competition, impacting pricing dynamics and revenue streams.

3. Regulatory Environment and Patent Landscape
Patent expirations in key markets—primarily in the late 2010s for several formulations—have resulted in increased generic competition, thereby sparking price reductions. Nonetheless, manufacturers leverage additional indications and combination patents to extend exclusivity. The regulatory landscape varies globally, influencing product registration timelines and market entry strategies.

4. Adoption Trends
Prescribing trends favor combination inhalers over monotherapies due to improved adherence, reduced inhaler errors, and superior efficacy (4). The convenience factor enhances patient compliance, positively impacting sales volumes.

5. Competitive Landscape
Major players include AstraZeneca, Teva Pharmaceuticals, Mylan, and Cipla. Each invests heavily in research and marketing to retain market share. Competitive dynamics are further shaped by proprietary formulations, inhaler technologies, and price strategies.

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Financial Trajectory

1. Revenue Growth and Market Size
The global inhaled corticosteroid/long-acting beta-agonist (ICS/LABA) combination market, including budesonide; formoterol fumarate, was valued at approximately USD 4.2 billion in 2022 (5). Projected compound annual growth rate (CAGR) estimates range from 5-7% through 2030, driven by the factors outlined above.

2. Regional Market Drivers

• North America: Dominant due to high prevalence, advanced healthcare infrastructure, and extensive formulary coverage. The U.S. alone accounts for over 40% of global sales.
• Europe: Strong market with growing adoption, especially in the UK, Germany, and France, supported by national respiratory disease initiatives.
• Asia-Pacific: Rapid growth forecasted, driven by rising respiratory disease prevalence, increasing healthcare access, and a large population base. Countries like China and India are expected to contribute significantly to revenue expansion.

3. Pricing and Reimbursement Dynamics
Product pricing varies widely, influenced by regional healthcare policies, insurance coverage, and patent status. Patent expirations have led to price erosions, but companies offset reduced unit prices via increased volume sales and expanded indications.

4. Market Challenges

• Generic Competition: Erodes profit margins post-patent expiry.
• Market Saturation: Established brand dominance limits growth.
• Pricing Pressure: Payer negotiations and cost-containment strategies influence profitability.
• Adverse Event Concerns: Monitoring for side effects like oral thrush and cardiovascular risks influences prescribing patterns.

5. Innovation and Pipeline Developments
Emerging inhaler technologies, such as soft-mist and dry powder inhalers, aim to enhance drug delivery efficiency, boosting product attractiveness. Additionally, novel combination therapies and personalized medicine approaches are in development, potentially impacting future financial trajectories.

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Future Outlook and Strategic Implications

The outlook for budesonide; formoterol fumarate remains cautiously optimistic. Market growth hinges on:

• Continued rise in respiratory disease prevalence.
• Regulatory pathways facilitating access in emerging markets.
• Innovations improving drug delivery and compliance.
• Strategic patent management to delay generic erosion.

Manufacturers that diversify portfolios through combination therapies, invest in clinical trials for new indications, and tailor marketing to regional needs will likely maintain a competitive edge and sustain revenue growth.

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Key Takeaways

• Market Expansion Driven by Disease Burden: Increasing prevalence of asthma and COPD globally sustains demand for budesonide; formoterol fumarate.
• Regional Growth Disparities: North America and Europe maintain leadership, but Asia-Pacific offers significant growth opportunities.
• Patent and Competition Dynamics: Patent expiries and generic entries exert downward pressure on prices, necessitating innovation and strategic patent management.
• Innovation as a Growth Catalyst: Advances in inhaler technology and pipeline products can influence future financial trajectories.
• Reimbursement and Pricing Strategies: Evolving healthcare policies substantially impact profitability and market access.

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FAQs

1. What factors influence the market share of budesonide; formoterol fumarate?
Market share is influenced by prevalence rates of breathing disorders, regulatory approvals, patent status, competitive product launches, pricing and reimbursement policies, and advancements in inhaler technology.

2. How do patent expirations affect the financial outlook?
Patent expirations typically lead to generic competition, reducing prices and margins. Companies counteract this through innovation, extending patent protections, and expanding indications.

3. Which regions are expected to drive future growth?
Asia-Pacific, with countries like China and India, is expected to see the fastest growth due to rising disease prevalence and expanding healthcare infrastructure.

4. How does innovation impact the drug’s market trajectory?
Technological improvements in inhaler delivery systems and the development of new combination formulations can improve adherence, efficacy, and patient outcomes, positively influencing sales.

5. What are the primary challenges facing manufacturers?
Key challenges include price competition from generics, regulatory hurdles, market saturation, and the need for continual innovation to differentiate products.

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References

1. Global Initiative for Asthma (GINA). "Global Strategy for Asthma Management and Prevention." 2022.
2. World Health Organization (WHO). "The Global Burden of Disease Study," 2021.
3. WHO. "Chronic obstructive pulmonary disease (COPD)." 2022.
4. Maher, T.M., et al. "Adherence and Inhaler Technique in COPD and Asthma." European Respiratory Journal, 2020.
5. MarketsandMarkets. "Inhalation Drug Delivery Market," 2022.

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In conclusion, the market for budesonide; formoterol fumarate remains robust amid evolving global respiratory health challenges and technological innovations. Strategic patent management, regional expansion, and continuous product development will be pivotal to sustaining its financial trajectory over the coming decade.