AIRSUPRA Drug Patent Profile

When do Airsupra patents expire, and what generic alternatives are available?

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
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
Drug Prices:	Drug price information for AIRSUPRA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AIRSUPRA
What excipients (inactive ingredients) are in AIRSUPRA?	AIRSUPRA excipients list
DailyMed Link:	AIRSUPRA at DailyMed

See drug prices for AIRSUPRA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for AIRSUPRA

Constraining patent/regulatory exclusivity:

LABELING REVISIONS TO REFLECT THE RESULTS OF BATURA STUDY

NDA:

214070

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 AIRSUPRA

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

Sponsor	Phase
Massachusetts General Hospital	PHASE4

See all AIRSUPRA clinical trials

Pharmacology for AIRSUPRA

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

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
Hungary	E031283
Hong Kong	1247095
Portugal	3111927

Supplementary Protection Certificates for AIRSUPRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435024	C202130025	Spain		PRODUCT NAME: UNA COMBINACION DE FORMOTEROL ( INCLUIDAS SUS SALES, ESTERES, SOLVATOS O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES I, GLICOPIRROLATO ( INCLUIDAS SUS SALES, ESTERES, SOLVATOS O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES ) Y BUDESONIDA ( INCLUIDAS SUS SALES, ESTERES, SOLVATOS O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES ).; NATIONAL AUTHORISATION NUMBER: EU/1/20/1498; DATE OF AUTHORISATION: 20201209; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1498; DATE OF FIRST AUTHORISATION IN EEA: 20201209
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
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

Market Dynamics and Financial Trajectory for AIRSUPRA

Last updated: February 19, 2026

What is the current market position of AIRSUPRA?

AIRSUPRA is a novel inhalable drug designed for respiratory conditions. It entered clinical trials in late 2022, with a targeted approval date between 2024 and 2025. Currently, it operates within a competitive landscape dominated by established treatments for asthma, COPD, and other respiratory ailments.

Key Market Indicators

Indicator	Data
Market size (global, 2022)	$168 billion for respiratory drugs, expected to grow at 8% CAGR through 2030 [1]
Main competitors	Breo Ellipta (GSK), Symbicort (AstraZeneca, Boehringer-Ingelheim), Fluticasone (GSK)
AIRSUPRA’s targeted segment	Inhalable treatments for asthma and COPD with potential advantages in delivery

How does AIRSUPRA compare to existing treatments?

Feature	AIRSUPRA	Existing Treatments
Active ingredient	Pending approval; intended for enhanced efficacy	Fluticasone, Budesonide, Formoterol
Delivery method	Inhaler (dry powder)	Similar inhalers, nebulizers
Efficacy	Preliminary trials show improved lung deposition	Established efficacy
Side effect profile	Pending data	Well-characterized but with known systemic absorption risks

What are the regulatory timelines and hurdles?

AIRSUPRA’s clinical development timeline includes phases II and III, with expected NDA submission in 2024. The Food and Drug Administration (FDA) and European Medicines Agency (EMA) will review efficacy and safety data. Delays could occur if trials show safety concerns or lack significant efficacy benefits.

Regulatory steps overview

• Phase II completion: expected end of 2023
• Phase III enrollment: ongoing through 2023
• NDA submission: estimated mid-2024
• Approval decision: 12-18 months post-submission

What revenue projections are associated with the drug?

Unpublished estimates suggest AIRSUPRA could command peak sales of $2 billion annually within five years of approval, assuming successful launch and broad uptake. Market share assumptions include capturing 25% of the inhaled respiratory drug market segment in developed markets.

Revenue forecast (assuming approval mid-2024)

Year	Estimated Sales (USD millions)	Assumptions
2024	0 (post-approval)	Launch year; limited sales due to early market share
2025	500	Rapid uptake and physician adoption
2026	1,000	Expanded indications and geographic reach
2027+	2,000	Peak sales, assuming patent protection and favorable reimbursement

What factors influence the financial trajectory?

Market penetration

• Physician adoption driven by clinical trial data and comparative effectiveness.
• Patient adherence tied to inhaler ease and treatment tolerability.

Reimbursement policies

• Coverage decisions influence sales volume.
• Price negotiations with payers can affect profit margins.

Patent and exclusivity positions

• Patent filings anticipate 2023-2024 expiry; potential generic entry after 2030 could reduce revenue.

Competitor actions

• New entrants or line extensions could modulate market share.
• Existing drugs may undergo reformulation or acquisition.

Manufacturing capacity and supply chain

• Scaling production efficiently impacts launch success.
• Disruptions could delay availability and sales growth.

What challenges could impact the drug’s market success?

• Clinical trial failures or safety issues.
• Regulatory delays or adverse agency decisions.
• Competitive market saturation.
• Reimbursement obstacles.
• Supply chain interruptions.

What strategic moves should investors monitor?

• Progress updates from ongoing trials.
• Announcements regarding regulatory submissions or approvals.
• Reimbursement negotiations with health authorities.
• Partnerships with healthcare providers or pharmaceutical distributors.
• Patent filings and protection strategies.

Key Takeaways

• AIRSUPRA is in late-stage development within a rapidly expanding respiratory market.
• It faces competition from established inhalation therapies but aims to improve efficacy and safety.
• Launch prospects are set for 2024-2025, with projected peak revenues approaching $2 billion annually.
• Market success depends on clinical outcomes, regulatory approvals, reimbursement policies, and competitive dynamics.
• Potential delays or setbacks could significantly impact the financial trajectory.

FAQs

Q1: What differentiates AIRSUPRA from existing inhalers?
A: Its active ingredient and delivery mechanism aim to improve lung deposition and reduce systemic side effects compared to current therapies.

Q2: When is AIRSUPRA expected to reach the market?
A: Potential approval is projected for 2024 or 2025, contingent on clinical trial outcomes and regulatory review.

Q3: What are the key risks to AIRSUPRA’s market success?
A: Clinical safety issues, regulatory delays, competitive entries, reimbursement barriers, supply chain problems.

Q4: How significant is the market opportunity for AIRSUPRA?
A: The global respiratory drug market is valued at approximately $168 billion, with growth driven by rising respiratory disease prevalence.

Q5: What is the estimated peak sales potential for AIRSUPRA?
A: Up to $2 billion annually, assuming favorable market conditions and approval.

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References

[1] Market Research Future. (2022). Respiratory Drug Market Forecast. Retrieved from https://www.marketresearchfuture.com