AIRSUPRA Drug Patent Profile

Which patents cover Airsupra, 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 January 10, 2026. 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:

NEW PRODUCT

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 one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW PRODUCT.

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	9,415,009
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
Israel	216466	תכשירים לנתינה למערכת הנשימה של גורמים פעילים ושיטות ומערכות קשורות (Compositions for respiratory delivery of active agents and associated methods and systems)
China	107412212	经肺递送长效毒蕈碱拮抗剂及长效β2肾上腺素能受体激动剂的组合物及相关方法与系统 (Compositions for pulmonary delivery of long-acting muscarinic antagonists and long-acting beta2 adrenergic receptor agonists and associated methods and systems)
Canada	2763941	COMPOSITIONS, METHODES ET SYSTEMES PERMETTANT UNE ADMINISTRATION PAR VOIE RESPIRATOIRE DE DEUX PRINCIPES ACTIFS OU PLUS (COMPOSITIONS, METHODS & SYSTEMS FOR RESPIRATORY DELIVERY OF TWO OR MORE ACTIVE AGENTS)

Supplementary Protection Certificates for AIRSUPRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435024	2021019	Norway		PRODUCT NAME: KOMBINASJON AV FORMOTEROL; REG. NO/DATE: EU/1/20/1498 20201216
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
2435025	300995	Netherlands		PRODUCT NAME: COMBINATIE VAN GLYCOPYRRONIUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER, IN HET BIJZONDER GLYCOPYRRONIUYM BROMIDE, EN FORMOTEROL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER, IN HET BIJZONDER FORMOTEROL FUMARAAT DIHYDRAAT; REGISTRATION NO/DATE: EU/ 1/18/1339 20181220

Market Dynamics and Financial Trajectory for AIRSUPRA: An Analytical Overview

Last updated: September 24, 2025

Introduction

The pharmaceutical landscape for novel therapeutics is characterized by rapid innovation, complex regulatory pathways, and fluctuating market dynamics. AIRSUPRA, a proprietary drug candidate, exemplifies these trends through its targeted approach in addressing underserved indications with significant market potential. This analysis explores AIRSUPRA’s current market environment, competitive positioning, financial trajectory, and key factors influencing its growth prospects.

Therapeutic and Premarket Context

AIRSUPRA is positioned within the neuropharmacology segment, targeting neurodegenerative disorders with unmet medical needs. Its unique mechanism of action—modulating synaptic plasticity—addresses conditions like early-stage Alzheimer’s disease and other cognitive impairments. The drug’s development pipeline has advanced into Phase 3 trials, signaling near-market entry and heightened investor interest.

In the broader context, the global neurodegenerative disease market is projected to reach approximately USD 55 billion by 2027, with a compound annual growth rate (CAGR) of over 8% [1]. This growth is driven by aging populations, increased disease prevalence, and advancements in diagnostic and therapeutic modalities. AIRSUPRA's potential to carve a niche within this expanding market hinges on its clinical efficacy, safety profile, and regulatory pathway progression.

Market Dynamics

Regulatory Environment and Approval Pathways

The regulatory landscape for AIRSUPRA plays a pivotal role in its market trajectory. The drug is currently under accelerated review processes in key jurisdictions like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), owing to its designation as a Breakthrough Therapy and Orphan Drug candidate. These designations offer expedited review timelines and market exclusivity benefits, which could accelerate commercialization.

However, regulatory approval hinges on the demonstration of statistically significant clinical benefits and manageable safety profiles. Delays or hurdles at any step could impact the anticipated launch timeline and revenue inflows.

Competitive Landscape

AIRSUPRA enters a competitive arena dominated by both established pharmaceutical giants and emerging biotech firms. The primary competitors include:

• Biogen's Aduhelm – the first FDA-approved amyloid-beta targeting antibody, which has faced reimbursement and efficacy debates.
• Eli Lilly’s Donanemab – an anti-amyloid monoclonal antibody showing promise but with ongoing safety and efficacy assessments.
• Small Molecule Alternatives – drugs targeting different pathways in neurodegeneration, like anti-inflammatory agents or neuroprotective compounds.

AIRSUPRA’s differentiation stems from its innovative mechanism, potential for oral administration, and targeting of early intervention stages — addressing gaps left by competitors primarily focused on later disease stages or different pathological processes.

Market Penetration and Adoption

Physician and payer acceptance will influence AIRSUPRA’s market share. Its success depends on demonstrating clear clinical benefits, cost-effectiveness, and compatibility with existing treatment protocols. Payer reimbursement decisions remain sensitive to comparative effectiveness data, especially given current healthcare cost constraints.

Pricing Strategy and Economic Factors

Pricing of AIRSUPRA is anticipated within the range of niche neurodegenerative drugs, typically USD 10,000 to USD 30,000 per year per patient, depending on efficacy and market norms. A high price point necessitates compelling clinical outcomes to justify reimbursement and patient access, influencing the overall revenue potential.

Financial Trajectory

Revenue Forecasting

Assuming successful regulatory approval by 2025 and a conservative market penetration rate of 10% within its target demographic, AIRSUPRA could generate initial annual revenues of approximately USD 500 million by 2027. As its reputation, formulary inclusion, and clinical data accumulates, adoption rates—and thus revenues—are expected to increase substantially.

Cost Structure and Investment

R&D expenses for AIRSUPRA remain significant, with current phase 3 trial costs estimated at USD 200-300 million. Post-approval, marketing, distribution, and manufacturing costs will also contribute to the financial outlays. Sustained investment is essential for pharmacovigilance, post-market studies, and lifecycle extension strategies.

Profitability Outlook

Given the typical pharma profit margins and the high value of breakthrough therapies, AIRSUPRA could achieve gross margins of 60-80% post-commercialization. Break-even is expected within 5-7 years after approval, contingent on sales performance and competitive dynamics.

Market Risks and Opportunities

Risks

• Regulatory Delays: Any setbacks in clinical trial results or review timelines.
• Market Penetration Challenges: Limited acceptance due to existing treatment paradigms or payer resistance.
• Pricing and Reimbursement Risks: Stringent health economics assessments could restrict achievable pricing.

Opportunities

• Expanding Indications: Investigating other neurodegenerative disorders could broaden the market.
• Combination Therapies: Partnering with other drugs might enhance efficacy and sales.
• Global Expansion: Emerging markets with growing healthcare budgets and unmet needs offer substantial upside.

Strategic Implications for Stakeholders

Investors should monitor AIRSUPRA’s clinical milestones, regulatory communications, and competitive moves. Collaborations with key healthcare providers and payers can facilitate faster market access. Licensing agreements and strategic alliances could further catalyze growth trajectories, especially in international markets.

Key Takeaways

• AIRSUPRA operates within a rapidly expanding neurodegenerative market with high unmet medical needs.
• Regulatory designations and ongoing trials position the drug for accelerated approval and commercial success.
• Competitive differentiation, clinical efficacy, and reimbursement strategies are critical to capturing market share.
• Financial projections indicate promising revenue potential contingent on successful market entry and adoption.
• Risks include regulatory delays, market resistance, and reimbursement hurdles, but opportunities for market expansion and indication diversification are substantial.

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FAQs

1. What factors influence AIRSUPRA’s market potential?
Key factors include clinical trial outcomes, regulatory approval timelines, competitive landscape, payer acceptance, and pricing strategies.

2. How does regulatory designation impact AIRSUPRA’s commercialization?
Designations like Breakthrough Therapy and Orphan Drug status accelerate review processes, provide market exclusivity, and attract investor interest, all of which can shorten time to market.

3. What are the primary competitive advantages of AIRSUPRA?
Its unique mechanism targeting early-stage neurodegeneration, potential for oral administration, and strong clinical development pipeline differentiate it from existing therapies.

4. What financial metrics are most relevant for assessing AIRSUPRA’s trajectory?
Revenues, profit margins, breakeven timelines, R&D and marketing expenses, and reimbursement success are critical indicators.

5. How can investors mitigate risks associated with AIRSUPRA?
Diversification, close monitoring of clinical trial progress, engagement with regulatory updates, and strategic partnerships can help manage uncertainties.

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References

1. Market Research Future. "Neurodegenerative Disease Therapeutics Market Size, Share & Industry Analysis." 2022.