ALBUTEROL SULFATE; BUDESONIDE - Generic Drug Details

What are the generic sources for albuterol sulfate; budesonide and what is the scope of freedom to operate?

Albuterol sulfate; budesonide is the generic ingredient in one branded drug marketed by Astrazeneca and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Albuterol sulfate; budesonide has one hundred and ninety-two patent family members in thirty-two countries.

One supplier is listed for this compound.

Summary for ALBUTEROL SULFATE; BUDESONIDE

International Patents:	192
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	4
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ALBUTEROL SULFATE; BUDESONIDE
DailyMed Link:	ALBUTEROL SULFATE; BUDESONIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ALBUTEROL SULFATE; BUDESONIDE

Constraining patent/regulatory exclusivity:

NEW PRODUCT

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 ALBUTEROL SULFATE; BUDESONIDE

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

Sponsor	Phase
AstraZeneca	PHASE3
Bond Avillion 2 Development LP	Phase 3
Parexel	Phase 3

See all ALBUTEROL SULFATE; BUDESONIDE clinical trials

Pharmacology for ALBUTEROL SULFATE; BUDESONIDE

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

Anatomical Therapeutic Chemical (ATC) Classes for ALBUTEROL SULFATE; BUDESONIDE

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

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

R03BA	Glucocorticoids
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

US Patents and Regulatory Information for ALBUTEROL SULFATE; BUDESONIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	AIRSUPRA	albuterol sulfate; budesonide	AEROSOL, METERED;INHALATION	214070-001	Jan 10, 2023		RX	Yes	Yes
Astrazeneca	AIRSUPRA	albuterol sulfate; budesonide	AEROSOL, METERED;INHALATION	214070-001	Jan 10, 2023		RX	Yes	Yes	9,415,009

International Patents for ALBUTEROL SULFATE; BUDESONIDE

Country	Patent Number	Title	Estimated Expiration
Lithuania	C2435024
Cyprus	2019031
Hungary	E047803
Ukraine	109529	КОМПОЗИЦІЇ ДЛЯ РЕСПІРАТОРНОЇ ДОСТАВКИ АКТИВНИХ АГЕНТІВ ТА ПОВ'ЯЗАНІ СПОСОБИ І СИСТЕМИ
Mexico	2011012685	COMPOSICIONES PARA SUMINISTRO PULMONAR DE ANTAGONISTAS MUSCARINICOS DE ACCION PROLONGADA Y AGONISTAS DE RECEPTOR B2 ADRENERGICO DE ACCION PROLONGADA Y METODOS Y SISTEMAS ASOCIADOS. (COMPOSITIONS FOR PULMONARY DELIVERY OF LONG-ACTING MUSCARINIC ANTAGONISTS AND LONG-ACTING B2 ADRENERGIC RECEPTOR AGONISTS AND ASSOCIATED METHODS AND SYSTEMS.)

Supplementary Protection Certificates for ALBUTEROL SULFATE; BUDESONIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435025	CA 2019 00032	Denmark		PRODUCT NAME: KOMBINATION AF GLYCOPYRROLAT, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERER ELLER ANDRE DERIVATER DERAF, OG FORMOTEROL, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERER ELLER ANDRE DERIVATER DERAF; REG. NO/DATE: EU/1/18/1339 20181220
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	PA2019014	Lithuania		PRODUCT NAME: GLIKOPIROLATO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, ENANTIOMERUS AR KITUS DARINIUS) IR FORMOTEROLIO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, ENANTIOMERUS AR KITUS DARINIUS) DERINYS; REGISTRATION NO/DATE: EU/1/18/1339 20181218
2435024	2021019	Norway		PRODUCT NAME: KOMBINASJON AV FORMOTEROL; REG. NO/DATE: EU/1/20/1498 20201216
2435025	C201930043	Spain		PRODUCT NAME: UNA COMBINACION DE GLICOPIRROLATO (INCLUYENDO CUALQUIERA DE SUS SALES, ESTERES O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES) Y FORMOTEROL (INCLUYENDO CUALQUIERA DE SUS SALES, ESTERES O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES).; NATIONAL AUTHORISATION NUMBER: EU/1/18/1339; DATE OF AUTHORISATION: 20181218; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1339; DATE OF FIRST AUTHORISATION IN EEA: 20181218

Market Dynamics and Financial Trajectory for Albuterol Sulfate and Budesonide

Last updated: September 22, 2025

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Introduction

Albuterol sulfate and budesonide are cornerstone medications in managing respiratory conditions such as asthma and COPD. Their combined applications, along with their individual efficacy profiles, position them as significant contributors to the pharmaceutical market. Analyzing their market dynamics and financial trajectories provides insight into future investment opportunities, competitive positioning, and innovation trends.

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Market Overview

Albuterol Sulfate

Albuterol sulfate, a beta-2 adrenergic agonist, is widely prescribed for acute bronchospasm. Traditionally delivered via metered-dose inhalers (MDIs), nebulizers, and dry powder inhalers, it commands a substantial share of the short-acting bronchodilator market. Its immediate onset of action makes it a first-line rescue medication.

Market Size & Growth
The global albuterol market was estimated at approximately USD 3.8 billion in 2021, with a compound annual growth rate (CAGR) of around 4.5% projected through 2028 (Grand View Research, 2022). The growth is propelled by rising asthma prevalence, especially in developing countries, along with increased awareness and improved delivery devices.

Budesonide

Budesonide, a corticosteroid with potent anti-inflammatory effects, is primarily prescribed for maintenance therapy in asthma and COPD. Its formulations include inhalers and nasal sprays, extending its therapeutic utility to allergic rhinitis. The emphasis on long-term control strategies supports steady demand.

Market Size & Growth
The global budesonide market was valued at nearly USD 1.1 billion in 2021, anticipated to expand at a CAGR of around 4% until 2028 (Fortune Business Insights, 2022). The market growth correlates with the increasing prevalence of respiratory diseases and the parallel evolution of combination inhalers.

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Market Drivers

• Rising Disease Burden: Increasing incidence and prevalence of asthma and COPD worldwide, especially in urbanized regions, drive demand for both drugs.
• Advancements in Delivery Technologies: Development of more efficient inhalers and nebulizers improves patient compliance and therapeutics, bolstering market growth.
• Generic and Biosimilar Competition: The patent expirations for several albuterol and budesonide formulations have led to a surge in generic options, intensifying price competition.
• Regulatory Support & Local Manufacturing: Supportive policies in emerging markets and local manufacturing capabilities amplify access and affordability.

Market Challenges

• Pricing Pressures & Reimbursement Policies: Governments and insurers are enforcing stricter reimbursement criteria, impacting profit margins.
• Concerns Over Steroid Use: Long-term corticosteroid use, associated with adverse effects, affects prescription practices.
• Generic Market Saturation: Increased availability of generics compresses revenue potential for branded manufacturers.
• Development of Alternative Therapies: The rise of biologics, such as monoclonal antibodies, introduces competition for long-term management.

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Pipeline and Innovation Trends

Albuterol

• Innovations in Delivery: Development of dry powder inhalers (DPIs) and Breath-Activated Inhalers.
• Prodrug Formulations & Combination Therapies: Combining albuterol with other agents to improve efficacy and reduce side effects.
• Novel Delivery Systems: Use of nanoparticle carriers to enhance bioavailability and reduce required doses.

Budesonide

• Formulation Expansion: Nasal sprays and inhalers with improved delivery profiles, e.g., budesonide/formoterol combination inhalers.
• Innovative Therapeutics: Research into targeted corticosteroid delivery to minimize systemic absorption.
• Biosimilars: Entry of biosimilar versions could reduce costs and increase access.

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Financial Trajectory Forecast

Revenue Projections

• Albuterol Market: Anticipated to reach USD 5.2 billion by 2028, driven by volume growth and off-label uses like exercise-induced bronchospasm management.
• Budesonide Market: Expected to approach USD 1.5 billion, supported by increased utilization of combination inhalers and novel formulations.

Profitability & Investment Trends

• Generic Manufacturers: Experience margins compression but benefit from high-volume sales.
• Innovative Drug Developers: Focus on reformulations and delivery devices could command premium pricing, sustaining profitability.
• Mergers & Acquisitions: Companies consolidate to expand portfolios and leverage economies of scale, potentially impacting market share distribution.

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Regulatory & Market Entry Considerations

• Regulatory Approvals: Navigating complex approvals for inhaler devices and combination products is critical for market entry in highly regulated jurisdictions.
• Intellectual Property: Patent expirations open opportunities for generics but also necessitate strategic patenting of novel formulations and delivery mechanisms.
• Pricing & Reimbursement Policies: Adaptation to local policies in high-growth markets, such as Asia-Pacific and Latin America, can substantially influence revenues.

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Conclusion & Strategic Implications

The markets for albuterol sulfate and budesonide display robust growth aligned with respiratory disease prevalence. Innovation in delivery systems, strategic patent management, and expansion into emerging markets are critical to maintaining competitive advantage. The path forward emphasizes balancing cost efficiency with the development of advanced formulations that meet evolving regulatory standards and patient needs.

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Key Takeaways

• The global market for albuterol and budesonide is projected to grow steadily through 2028, driven by rising respiratory disease burdens worldwide.
• Innovation in delivery devices and combination therapies will be the primary drivers of future revenue streams.
• Generic entry presents both challenges in profit margins and opportunities for broader access.
• Companies investing in biosimilar development and advanced delivery technologies are poised for sustained growth.
• Navigating regulatory landscapes and local reimbursement policies remains pivotal for market expansion, especially in emerging markets.

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FAQs

1. What are the primary factors influencing the market growth for albuterol sulfate and budesonide?
   Rising prevalence of asthma and COPD, technological advancements in inhaler devices, and expanding use in emerging markets are key growth drivers.

2. How does patent expiration impact the profitability of these drugs?
   Patent expirations enable generic manufacturers to enter the market, increasing competition and reducing branded drug revenues, though they also expand access.

3. Are there any emerging therapies expected to challenge albuterol and budesonide?
   Yes, biologic therapies and novel oral medications targeting underlying inflammatory pathways are gaining attention but currently complement rather than replace inhaled therapies.

4. What role do combination inhalers play in future market dynamics?
   They enhance adherence, provide synergistic effects, and are favored in long-term disease management, boosting their market share.

5. How critical is regional market expansion for the growth of these drugs?
   Vital; developing countries with rising respiratory disease burdens offer expanding opportunities, especially when accompanied by local manufacturing and regulatory navigation.

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References

[1] Grand View Research. "Albuterol Market Size, Share & Trends Analysis Report," 2022.
[2] Fortune Business Insights. "Budesonide Market Size, Share & Industry Analysis," 2022.