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 eighty-four patent family members in thirty-one countries.

One supplier is listed for this compound.

Summary for ALBUTEROL SULFATE; BUDESONIDE

International Patents:	184
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	3
DailyMed Link:	ALBUTEROL SULFATE; BUDESONIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ALBUTEROL SULFATE; BUDESONIDE

Constraining patent/regulatory exclusivity:

NEW PRODUCT

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
Bond Avillion 2 Development LP	Phase 3
Parexel	Phase 3
AstraZeneca	Phase 1

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

International Patents for ALBUTEROL SULFATE; BUDESONIDE

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)

Supplementary Protection Certificates for ALBUTEROL SULFATE; BUDESONIDE

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

ALBUTEROL SULFATE; BUDESONIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Albuterol Sulfate and Budesonide

Introduction to Albuterol Sulfate and Budesonide

Albuterol sulfate and budesonide are two critical medications in the management of respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD). Here, we delve into the market dynamics and financial trajectory of these drugs, highlighting key drivers, growth projections, and market trends.

Market Size and Growth Projections

Albuterol Sulfate Inhalation Aerosol Market

The global albuterol sulfate inhalation aerosol market is anticipated to experience significant growth. As of 2023, the market was valued at approximately USD 5.22 billion and is projected to reach USD 9.14 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 8.32% during the forecast period[1][4].

Budesonide Inhaler Market

The global budesonide inhaler market was valued at USD 6,899.6 million in 2022 and is expected to grow at a CAGR of 6.0% from 2022 to 2030. This growth is driven by increasing launches of generic versions of budesonide inhalers and the rising prevalence of respiratory diseases[3].

Key Drivers of Market Growth

Rising Incidences of Respiratory Disorders

The increasing prevalence of asthma and COPD is a major driver for both markets. In the U.S., for instance, 8.4% of adults and 5.8% of children under 18 have been diagnosed with asthma, while 5.0% of the population has been diagnosed with COPD, emphysema, or chronic bronchitis[3][5].

Advancements in Inhalation Therapy

Innovations in inhaler technology, such as metered-dose and dry powder inhalers, are expanding treatment options and accessibility. For example, the approval of Airsupra (albuterol/budesonide) as a first-in-class pressurized metered-dose inhaler (pMDI) marks a significant advancement in asthma management[5].

Regulatory Approvals and Generic Formulations

Regulatory approvals for generic formulations are driving growth. For example, Cipla Limited received FDA approval for its generic version of albuterol sulfate inhalation aerosol, which is bioequivalent to Merck Sharp & Dohme Corp’s Proventil HFA Inhalation Aerosol[3].

Impact of COVID-19

The COVID-19 pandemic has also contributed to market growth. Early treatment with inhaled budesonide was found to shorten recovery time in non-hospitalized patients with COVID-19, highlighting the utility of these medications beyond traditional respiratory conditions[3].

Financial Trajectory

Cost and Affordability Initiatives

To address affordability barriers, companies like AstraZeneca are implementing cost-capping measures. Starting June 1, 2024, eligible patients will pay no more than $35 per month for all AstraZeneca US inhaled respiratory medicines, including those containing albuterol and budesonide[2].

Market Size Projections

• Albuterol Sulfate: The market is expected to grow from USD 5.22 billion in 2023 to USD 9.14 billion by 2030[1].
• Budesonide: The market was valued at USD 6,899.6 million in 2022 and is expected to grow at a CAGR of 6.0% until 2030[3].

Revenue Streams

The revenue streams for these medications are diverse, including sales from both branded and generic versions. The U.S. asthma drugs market, which includes these medications, was valued at USD 8.95 billion in 2023 and is projected to surpass USD 14.75 billion by 2033, with a CAGR of 5.12%[5].

Market Trends

Increasing Prevalence of Respiratory Diseases

The increasing prevalence of asthma and COPD, particularly in the U.S., is a significant trend driving market growth. These conditions affect millions of individuals, resulting in a substantial financial burden estimated at approximately $56 billion annually in the U.S.[5].

Innovations in Treatment

The approval of new treatments like Airsupra and TEZSPIRE (for severe asthma) indicates a trend towards more effective and safer treatments. These innovations are expected to drive market growth by offering better patient outcomes and reducing the risk of severe exacerbations[5].

Patient Education and Healthcare Reforms

Patient education programs and healthcare reforms promoting respiratory health awareness are also supporting market expansion. These initiatives help in increasing the adoption of these medications and improving patient compliance[4].

Regional Market Analysis

Global Market Share

The global market share for both albuterol sulfate and budesonide inhalers varies by region. The U.S. is a significant market due to the high prevalence of respiratory diseases and the presence of major pharmaceutical companies[3][5].

Regional Growth Drivers

Regional growth is driven by factors such as increasing air pollution levels, urbanization, and improvements in healthcare access. In regions with high air pollution, the demand for respiratory medications is expected to rise, contributing to market growth[4].

Competitive Landscape

Key Players

Major players in the market include AstraZeneca, Cipla Limited, and Merck Sharp & Dohme Corp. These companies are investing in research and development to introduce new formulations and improve existing ones[2][3].

Competitive Strategies

Companies are adopting strategies such as cost-capping, expanding savings programs, and innovating in inhaler technology to stay competitive. AstraZeneca’s commitment to addressing affordability barriers is a notable example[2].

Challenges and Opportunities

Affordability and Access

Despite the growth, affordability and access remain significant challenges. Financial barriers restrict access to care, particularly for low-income individuals without health insurance. Initiatives like Medicaid and the Children’s Health Insurance Plan help but do not fully address the issue[5].

Regulatory Environment

The regulatory environment is crucial for market growth. Approvals for generic formulations and new treatments are essential for expanding the market. However, regulatory complexities can also pose challenges[3].

Key Takeaways

• The albuterol sulfate inhalation aerosol market is expected to grow at a CAGR of 8.32% from 2023 to 2030.
• The budesonide inhaler market is projected to grow at a CAGR of 6.0% from 2022 to 2030.
• Increasing prevalence of respiratory diseases, advancements in inhalation therapy, and regulatory approvals for generic formulations are key drivers.
• Affordability initiatives and innovations in treatment are significant trends.
• The U.S. asthma drugs market, which includes these medications, is expected to surpass USD 14.75 billion by 2033.

FAQs

What is the projected market size for albuterol sulfate inhalation aerosol by 2030?

The global albuterol sulfate inhalation aerosol market is expected to reach USD 9.14 billion by 2030[1].

How is the budesonide inhaler market expected to grow?

The budesonide inhaler market is expected to grow at a CAGR of 6.0% from 2022 to 2030, driven by increasing launches of generic versions and rising prevalence of respiratory diseases[3].

What are the key drivers of the albuterol sulfate and budesonide markets?

Key drivers include the rising incidence of respiratory disorders, advancements in inhalation therapy, and regulatory approvals for generic formulations[1][3][4].

How are companies addressing affordability barriers for these medications?

Companies like AstraZeneca are implementing cost-capping measures, such as limiting patient out-of-pocket costs to $35 per month for eligible patients[2].

What is the impact of COVID-19 on the market for these medications?

COVID-19 has driven growth by highlighting the utility of these medications in shortening recovery times in non-hospitalized patients, among other factors[3].

Sources

1. Exactitude Consultancy: "Albuterol Sulfate Inhalation Aerosol Market Trend Shows Outstanding Growth at a CAGR of 8.32% by 2030"[1].
2. AstraZeneca: "AstraZeneca caps patient out-of-pocket costs at $35 per month for its US inhaled respiratory medicines"[2].
3. Coherent Market Insights: "Budesonide Inhaler Market Size and Trends"[3].
4. Market Research Intellect: "Global Albuterol Sulfate Inhalation Aerosol Market Size and Projections"[4].
5. BioSpace: "U.S. Asthma Drugs Market Size to Surpass USD 14.75 Bn by 2033"[5].