~ Buy the AIRSUPRA (albuterol sulfate; budesonide) Drug Profile, 2024 PDF Report in the Report Store ~

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 eighty-four patent family members in thirty-one 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.

Indicators of Generic Entry

Summary for AIRSUPRA

International Patents:	184
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information 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.

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
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
South Korea	20190049943	활성제의 호흡기 전달 (RESPIRATORY DELIVERY OF ACTIVE AGENTS)
Australia	2015201037	Respiratory delivery of active agents
Montenegro	03631	SASTAVI ZA ISPORUKU AKTIVNIH AGENASA U DISAJNE PUTEVE I POVEZANI POSTUPCI I SISTEMI (COMPOSITIONS FOR RESPIRATORY DELIVERY OF ACTIVE AGENTS AND ASSOCIATED METHODS AND SYSTEMS)
Japan	2015199735	２つ以上の活性剤を呼吸器送達するための組成物、方法および系 (COMPOSITION, METHOD AND SYSTEM FOR DELIVERING TWO OR MORE ACTIVATORS TO RESPIRATORY ORGAN)
Hungary	E047823

Supplementary Protection Certificates for AIRSUPRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	2019C/532	Belgium		PRODUCT NAME: UNE COMBINAISON DE GLYCOPYRROLATE (INCLUANT LES SELS ACCEPTABLES PHARMACEUTIQUEMENT, LES ESTERS, LES ENANTIOMERES OU LES AUTRES DERIVES DE CECI) ET DE FORMOTEROL (INCLUANT LES SELS ACCEPTABLES PHARMACEUTIQUEMENT, LES ESTERS, LES ENANTIOMERES OU LES AUTRES DERIVES DE CECI); AUTHORISATION NUMBER AND DATE: EU/1/18/1339 20181220
2435025	2019026	Norway		PRODUCT NAME: KOMBINASJON AV GLYKOPYRROLAT (INKLUDERT EVENTUELLE FARMASOEYTISK AKSEPTABLE SALTER, ESTERE ELLER ENANTIOMERER DERAV) OG FORMOTEROL (INNBEFATTENDE HVILKE SOM HELST FARMASOEYTISK AKSEPTABLE SALTER, ESTERE ELLER ENANTIOMERER DERAV); REG. NO/DATE: EU/1/18/1339 20190104
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

AIRSUPRA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for AIRSUPRA

Introduction to AIRSUPRA

AIRSUPRA, a groundbreaking medication developed by AstraZeneca, represents a significant advancement in the management of asthma. This drug is a fixed-dose combination of albuterol, a short-acting beta-2 agonist, and budesonide, an inhaled corticosteroid (ICS), delivered through a pressurized metered-dose inhaler (pMDI)[1][4].

Market Need and Demand

Asthma, a chronic respiratory condition, affects millions globally, including approximately 25 million individuals in the United States. The prevalence of asthma and the associated healthcare costs, estimated at around $56 billion annually, create a substantial demand for effective and innovative treatments. The approval of AIRSUPRA addresses this need by offering a more effective and convenient treatment option for patients with moderate to severe asthma[4].

Regulatory Approvals and Launch

AIRSUPRA received FDA approval in January 2023 for the as-needed treatment or prevention of asthma symptoms and to help prevent sudden severe breathing problems (asthma attacks) in people aged 18 years and older. This approval was based on the results from two Phase III trials, MANDALA and DENALI, which demonstrated AIRSUPRA's superiority over albuterol in reducing the risk of severe asthma exacerbations[1][4].

Clinical Efficacy

Clinical studies have shown that AIRSUPRA significantly reduces the risk of severe asthma attacks. For instance, in adult patients, treatment with AIRSUPRA demonstrated a 28% reduction in the risk of severe asthma attacks compared to albuterol. This therapeutic superiority underscores the potential of AIRSUPRA to become a leading treatment option in the asthma drugs market[4].

Market Impact and Growth

The introduction of AIRSUPRA is expected to drive growth in the asthma drugs market. Here are some key points:

• Market Size and Growth: The global asthma drugs market is projected to grow from USD 25.90 billion in 2024 to USD 36.73 billion by 2029, at a CAGR of 5.88%. In the U.S., the market is expected to grow from USD 8.95 billion in 2023 to USD 14.75 billion by 2033, with a CAGR of 5.12%[1][3][4].

• Segment Dominance: The adult segment is expected to maintain its dominance in the U.S. asthma drugs market, with AIRSUPRA playing a significant role due to its efficacy and convenience[4].

• Technological Advancements: The development of AIRSUPRA and similar innovative treatments is driven by technological advancements, such as the evolution of biomarkers and targeted therapies. These advancements are expected to create significant opportunities for market growth[1].

Financial Trajectory

The financial performance of AIRSUPRA is closely tied to AstraZeneca's overall financial health and the broader market trends.

• Revenue Growth: AstraZeneca's total revenue increased by 19% to $39,182 million in the first nine months of 2024, driven by strong performance across various therapy areas, including respiratory diseases. The approval and launch of AIRSUPRA are expected to contribute to this revenue growth[5].

• Product Sales: The approval of AIRSUPRA has enhanced AstraZeneca's product portfolio, which is anticipated to drive increased product sales. For instance, the company's respiratory and immunology segment has seen significant growth, partly due to the success of new products like AIRSUPRA[1][5].

• Cost and Accessibility: Despite the financial burden associated with asthma treatment, the introduction of AIRSUPRA is expected to offer a more cost-effective and accessible treatment option. However, challenges related to healthcare affordability, particularly for low-income individuals, may still impact the market's full potential[4].

Competitive Landscape

The asthma drugs market is highly competitive, with several key players investing in research and development to bring innovative treatments to the market.

• Product Approvals and Launches: Companies like AstraZeneca, with the launch of AIRSUPRA, and Pulmatrix, with its ongoing trials for PUR1900, are driving market growth through product approvals and launches. These strategies increase product availability and cater to the needs of high-risk patient groups[1].

• Partnerships and Collaborations: Collaborations, such as Pulmatrix's partnership with Cipla, are also crucial in delivering innovative therapies for asthma patients. These partnerships can accelerate the development and distribution of new treatments, further enhancing market growth[1].

Key Takeaways

• Innovative Treatment: AIRSUPRA represents a significant advancement in asthma treatment, offering a fixed-dose combination of albuterol and budesonide.
• Clinical Efficacy: AIRSUPRA has demonstrated superior efficacy in reducing severe asthma exacerbations compared to traditional treatments.
• Market Growth: The introduction of AIRSUPRA is expected to drive growth in the asthma drugs market, particularly in the adult segment.
• Financial Impact: AIRSUPRA's approval and launch are anticipated to contribute to AstraZeneca's revenue growth and enhance the company's product portfolio.
• Competitive Landscape: The market is highly competitive, with multiple players investing in innovative treatments and collaborations to meet patient needs.

FAQs

What is AIRSUPRA, and how does it differ from traditional asthma treatments?

AIRSUPRA is a fixed-dose combination of albuterol, a short-acting beta-2 agonist, and budesonide, an inhaled corticosteroid (ICS), delivered through a pressurized metered-dose inhaler (pMDI). It differs from traditional treatments by offering a more convenient and effective as-needed treatment option with reduced systemic corticosteroid exposure.

What are the key clinical benefits of AIRSUPRA?

AIRSUPRA has demonstrated a significant reduction in the risk of severe asthma attacks, with a 28% reduction compared to albuterol in adult patients. It also reduces systemic corticosteroid exposure, minimizing side effects.

How does AIRSUPRA impact the asthma drugs market?

The introduction of AIRSUPRA is expected to drive growth in the asthma drugs market, particularly in the adult segment, due to its efficacy and convenience.

What are the financial implications of AIRSUPRA for AstraZeneca?

AIRSUPRA's approval and launch are anticipated to contribute to AstraZeneca's revenue growth, enhancing the company's product portfolio and driving increased product sales.

What challenges might AIRSUPRA face in the market?

Despite its benefits, AIRSUPRA may face challenges related to healthcare affordability, particularly for low-income individuals, which could restrict access to care and limit the market's full potential.

How does AIRSUPRA compare to other recent asthma drug approvals?

AIRSUPRA stands out due to its innovative delivery mechanism and significant clinical efficacy. For example, the approval of TEZSPIRE for self-administration in a pre-filled pen also marks an advancement, but AIRSUPRA's fixed-dose combination and pMDI delivery set it apart[1][4].

Sources

1. Mordor Intelligence: Asthma Drugs Market Size & Share Analysis.
2. AstraZeneca: Full year and Q4 2022 results.
3. NovaOne Advisor: U.S. Asthma Drugs Market Size, Share & Growth Report, 2033.
4. BioSpace: U.S. Asthma Drugs Market Size to Surpass USD 14.75 Bn by 2033.
5. AstraZeneca: 9M and Q3 2024 results Upgrade.