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:

LABELING REVISIONS TO REFLECT THE RESULTS OF BATURA STUDY

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
Astrazeneca	AIRSUPRA	albuterol sulfate; budesonide	AEROSOL, METERED;INHALATION	214070-001	Jan 10, 2023		RX	Yes	Yes

International Patents for ALBUTEROL SULFATE; BUDESONIDE

Country	Patent Number	Title	Estimated Expiration
Netherlands	300995
Hungary	E031283
Mexico	337126
Portugal	2435024
Taiwan	I707700
Australia	2010253770
European Patent Office	3111926

Supplementary Protection Certificates for ALBUTEROL SULFATE; BUDESONIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435025	36/2019	Austria		PRODUCT NAME: GLYCOPYRRONIUMBROMID / FORMOTEROL; REGISTRATION NO/DATE: EU/1/18/1339 (MITTEILUNG) 20181220
2435024	15/2021	Austria		PRODUCT NAME: FORMOTEROLFUMARAT-DIHYDRAT / GLYCOPYRRONIUMBROMID / BUDESONID; REGISTRATION NO/DATE: EU/1/20/1498 (MITTEILUNG) 20201210
2435024	301102	Netherlands		PRODUCT NAME: COMBINATIE VAN FORMOTEROL (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN), GLYCOPYRROLAAT (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN) EN BUDESONIDE (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN); REGISTRATION NO/DATE: EU/1/20/1498 20201210
2435024	202140009	Slovenia		PRODUCT NAME: COMBINATION OF FORMOTEROL (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, SOLVATES OR ENANTIOMERS THEREOF), GLYCOPYRROLATE (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, SOLVATES OR ENANTIOMERS THEREOF) AND BUDESONIDE (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, SOLVATES OR ENANTIOMERS THEREOF); NATIONAL AUTHORISATION NUMBER: EU/1/20/1498; DATE OF NATIONAL AUTHORISATION: 20201209; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2435024	SPC/GB21/029	United Kingdom		PRODUCT NAME: A COMBINATION OF FORMOTEROL, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, GLYCOPYRROLATE, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, AND BUDESONIDE INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ES; REGISTERED: UK EU/1/20/1498 (NI) 20201210; UK PLGB 17901/0352-001 20201210
2435024	CA 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
2435024	LUC00208	Luxembourg		PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), DE GLYCOPYRRONIUM (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE BUDESONIDE (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1468 20201210

Market Dynamics and Financial Trajectory for Albuterol Sulfate and Budesonide

Last updated: February 20, 2026

What Are the Key Market Drivers?

The global market for respiratory drugs like albuterol sulfate and budesonide is driven by increasing prevalence of asthma, chronic obstructive pulmonary disease (COPD), and other respiratory conditions. Consumption growth is bolstered by aging populations, rising air pollution, and urbanization. The Covid-19 pandemic also increased focus on respiratory health, accelerating demand for inhalers and corticosteroids.

Albuterol sulfate: The primary short-acting beta-agonist (SABA) used for acute bronchospasm relief. The drug is prescribed for asthma and COPD exacerbations worldwide, with an estimated global market size of approximately USD 3.2 billion in 2021.

Budesonide: A corticosteroid used for maintenance therapy in asthma and COPD, especially in inhalers and nasal sprays. It accounts for roughly USD 1.6 billion in global revenues as of 2021.

How Do Market Trends Affect These Drugs?

Market Expansion

The global respiratory drugs market projected a compound annual growth rate (CAGR) of approximately 4.8% from 2022 to 2028. These drugs benefit from policies favoring inhaler use and the development of new formulations.

Patent and Generic Dynamics

Many patents for original inhaler formulations have expired or will do so over the next five years, opening markets for generics. For example:

• Albuterol inhalers lost exclusivity in the U.S. in 2018.
• Budesonide patents expired in Europe in 2020 and in the U.S. in 2022.

Regulatory Environment

The U.S. FDA and EMA have streamlined approval processes for generic inhalers, reducing barriers for market entry but also increasing competition. Concerns over inhaler environmental impact have led to the development of greener propellants, influencing formulary decisions.

Emerging Markets

Growth in pharmaceutical markets in Asia-Pacific, Latin America, and Africa enhances sales potential. These regions face rising disease burdens and limited access to healthcare.

What Are the Competitive and Patent Challenges?

Leading brands include:

• Albuterol sulfate: Brands like Ventolin (GlaxoSmithKline), ProAir (Teva), and generic versions.
• Budesonide: Brands like Pulmicort (AstraZeneca), with multiple generics following patent expiry.

Patent expirations have precipitated a surge in generics, impacting revenues of original patentees. The introduction of new delivery systems, such as dry powder inhalers, is creating new revenue streams, especially for innovator companies.

What Do Financial Trajectories Look Like?

Revenue Trends

Drug	2021 Revenue (USD billion)	CAGR (2022–2028)	Key Factors
Albuterol sulfate	3.2	4.8%	Volume-driven with widespread generic competition
Budesonide	1.6	4.5%	Steady growth in inhaler formulations; increased adoption in India and China

Profitability Outlook

• Revenue erosion expected for some branded formulations due to generics.
• Innovation in inhaler design and drug delivery could sustain or grow margins.
• Overall profitability for new inhaler formulations is improving with patent protections and market differentiation strategies.

Investment Considerations

• Companies with diversified inhaler portfolios see more stable revenues.
• Innovation in environmentally friendly inhalers provides an entry barrier for competitors.
• Emerging markets present high-growth opportunities but require local regulatory compliance.

Are There Key Regulatory or Pricing Pressures?

Yes. Governments are implementing stricter pricing controls for inhalers, especially in Europe and Canada. The U.S. market faces potential changes to Medicaid and Medicare reimbursement policies, which can impact profit margins. Environmental regulations on propellants (e.g., hydrofluoroalkanes) influence manufacturing costs.

Summary of Market Risks

• Patent cliffs for key formulations lead to revenue declines.
• Increased competition from generics and biosimilars.
• Price pressures from government programs and private payers.
• Regulatory hurdles for new formulations or delivery systems.
• Supply chain disruptions affecting raw materials or manufacturing volumes.

Key Takeaways

• The global respiratory drug market is growing driven by disease prevalence and aging populations.
• Albuterol sulfate and budesonide face declining revenues due to patent expirations, countered by new formulations and delivery methods.
• Market expansion is significant in emerging economies.
• Regulatory and environmental considerations are increasingly shaping product development and commercialization.
• Companies investing in inhaler innovation and emerging markets are positioned for growth.

FAQs

1. When will patent expirations impact albuterol and budesonide markets?
Albuterol inhaler patents expired in the U.S. in 2018; additional formulations are approaching patent cliffs. Budesonide patents expired across Europe in 2020 and in the U.S. in 2022.

2. How does environmental regulation influence inhaler markets?
Restrictions on propellants have led to the development of greener inhalers, affecting product costs and innovation strategies.

3. What are the primary drivers of growth in emerging markets?
Increasing respiratory disease burden, rising healthcare access, and expanding pharmaceutical infrastructure.

4. How do generic entrants affect profitability?
Generic competition lowers prices and margins, especially for drugs with basic formulations. Innovation in delivery systems is critical to maintaining market share.

5. What are the prospects for new formulations of these drugs?
Inhalers with improved delivery mechanisms and environmentally friendly features are gaining approval, offering growth opportunities for investees.

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References

[1] MarketsandMarkets. (2022). Respiratory Drugs Market by Drug Type, Application, and Region - Global Forecast to 2028.
[2] U.S. Food and Drug Administration. (2022). List of Approved Inhalers and Formulation Patents.
[3] IMS Health. (2021). Global Respiratory Pharmaceuticals Forecast.
[4] European Medicines Agency. (2021). Review of Inhaler Environmental Impact Regulations.
[5] IQVIA. (2022). Pharma Market Analysis and Trends in Emerging Regions.