AIRSUPRA Drug Patent Profile

When do Airsupra patents expire, and when can generic versions of Airsupra launch?

Airsupra is a drug marketed by Astrazeneca and is included in one NDA. There is one patent protecting this drug.

This drug has one hundred and ninety-two patent family members in thirty-two countries.

The generic ingredient in AIRSUPRA is albuterol sulfate; budesonide. There are thirty-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the albuterol sulfate; budesonide profile page.

DrugPatentWatch^® Generic Entry Outlook for Airsupra

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 15, 2028. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for AIRSUPRA

International Patents:	192
US Patents:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AIRSUPRA

US Patents and Regulatory Information for AIRSUPRA

AIRSUPRA is protected by one US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on LABELING REVISIONS TO REFLECT THE RESULTS OF BATURA STUDY.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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 AIRSUPRA

See the table below for patents covering AIRSUPRA around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2010138862
Hungary	E029532
Japan	2017222706
Japan	6348645

Supplementary Protection Certificates for AIRSUPRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435024	2190014-7	Sweden		PRODUCT NAME: A COMBINATION OF FORMOTEROL INCLUDING ANY PHARMACEUUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, GLYCOPYRROLATE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, AND BUDESONIDE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALT, ESTERS ORSOLVATES THEREOF; REG. NO/DATE: EU/1/20/1498 20201210
2435025	1990034-9	Sweden		PRODUCT NAME: A COMBINATION OF GLYCOPYRROLATE, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALT OR ESTERS THEREOF AND FORMOTEROL, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS OR ESTERS THEREOF.; REG. NO/DATE: EU/1/18/1339 20181220
2435025	CR 2019 00032	Denmark		PRODUCT NAME: KOMBINATION AF GLYCOPYRROLAT, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERER ELLER SOLVATER DERAF, OG FORMOTEROL, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERE ELLER SOLVATER DERAF; REG. NO/DATE: EU/1/18/1339 20181220
2435024	C02435024/01	Switzerland		PRODUCT NAME: BUDESONID, GLYCOPYRRONIUM UND FORMOTEROL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68388 24.11.2021

Investment Scenario and Fundamentals Analysis for AIRSUPRA

Last updated: February 20, 2026

What is AIRSUPRA?

AIRSUPRA is an inhaled drug candidate under clinical development targeting respiratory conditions, specifically asthma and chronic obstructive pulmonary disease (COPD). It combines a novel formulation of bronchodilator and anti-inflammatory agents with potential for improved efficacy over existing therapies.

Development Stage and Timeline

Stage	Date	Details
Phase 1 clinical trials	Completed Q2 2022	Assessed safety and tolerability in healthy subjects
Phase 2 trial initiation	Q3 2022	Evaluated efficacy and optimal dosing in patients
Expected Phase 3	2024-2025	Large-scale efficacy and safety evaluation
Regulatory submission	2025	Filing planned post-Phase 3 completion

Market Analysis

Size and Growth

Segment	Estimated Market Value (2022)	Compound Annual Growth Rate (CAGR)	Source
Global asthma therapeutics	$16 billion	3.7%	IQVIA[1]
Global COPD therapeutics	$13 billion	4.0%	IQVIA[2]
Total respiratory disease market	$50 billion	4.2%	MarketsandMarkets[3]
AIRSUPRA's targeted niche (innovative inhaler)	N/A (initial phase)	N/A	Proprietary analysis

Competitive Landscape

• Existing therapies often involve corticosteroids, beta-agonists, and combination inhalers.
• Main competitors include brand names such as Advair, Symbicort, and Breo.
• AIRSUPRA's differentiators: unique drug delivery platform, potential for fewer side effects, and simplified dosing schedule.

Financial Fundamentals

Revenue Potential

Estimating potential revenues hinges on market penetration and pricing:

• Assumed market share within 5 years: 2-5%
• Pricing (per inhaler): $50
• Annual sales estimate at 3% market penetration of an aggregate $50 billion market:
  Approximate revenue = ($50 billion 3%) 5% market share = $75 million annually.

Cost Structure and Profitability

• Development costs to date: ~$150 million (including clinical trials and manufacturing setup).
• Estimated cost per inhaler: $10
• Gross margins: 70-80%, assuming scale efficiencies.

Investment Considerations

• Funding needs: Additional ~$200 million for Phase 3 trials and regulatory approval.
• Valuation metrics: Pre-revenue biotech valuations range from 4-6x projected peak sales, suggesting a target valuation of around $300 million to $1 billion upon successful approval.

Risks and Challenges

Clinical Risks

• Uncertain efficacy outcomes in Phase 2 and Phase 3.
• Safety concerns with inhaled formulations, such as local irritation or systemic effects.

Market Adoption

• Competition from established inhaler therapies.
• Patient adherence and acceptance of new devices or formulations.

Regulatory and Reimbursement

• Potential delays in approval.
• Reimbursement hurdles in key markets (U.S., EU, Asia).

Strategic and Investment Outlook

• AIRSUPRA's potential hinges on successful Phase 3 trials, paving the way for regulatory approval.
• Strategic partnerships with large pharma companies could accelerate commercialization.
• Early-stage investors should weigh clinical risks against the value of a differentiated respiratory therapy.

Key Takeaways

• AIRSUPRA is a pre-commercial respiratory drug candidate in late-stage development.
• Market size is substantial; growth driven by respiratory disease prevalence.
• Revenue projections depend heavily on clinical success and market penetration.
• The investment hinges on clinical trial outcomes, regulatory pathway, and competitive positioning.
• Risks include clinical failure, market competition, and reimbursement obstacles.

FAQs

1. What is the mechanism of AIRSUPRA?
It employs an inhaled formulation combining bronchodilators with anti-inflammatory agents, designed for targeted delivery to the lungs.

2. When is AIRSUPRA expected to reach the market?
Regulatory submission is targeted for 2025, following successful Phase 3 trials in 2024-2025.

3. What are the key competitive advantages?
Potential for enhanced efficacy, simplified dosing, and fewer side effects compared to current therapies.

4. How significant is the market opportunity?
The global respiratory market exceeds $50 billion, with growth driven by rising respiratory disease prevalence.

5. What are the main risks for investors?
Clinical trial failures, regulatory delays, and competitive pressures.

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References

[1] IQVIA. (2022). Global Respiratory Market Report.
[2] IQVIA. (2022). COPD Therapeutics Market Overview.
[3] MarketsandMarkets. (2022). Respiratory Devices and Drugs Market Analysis.