PROVENTIL Drug Patent Profile

Which patents cover Proventil, and what generic alternatives are available?

Proventil is a drug marketed by Schering and Kindeva and is included in six NDAs.

The generic ingredient in PROVENTIL is albuterol sulfate. There are thirty-eight drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Proventil

A generic version of PROVENTIL was approved as albuterol sulfate by SUN PHARM INDUSTRIES on December 5^th, 1989.

Summary for PROVENTIL

US Patents:	0
Applicants:	2
NDAs:	6
Raw Ingredient (Bulk) Api Vendors:	133
Clinical Trials:	19
Drug Prices:	Drug price information for PROVENTIL
Drug Sales Revenues:	Drug sales revenues for PROVENTIL
DailyMed Link:	PROVENTIL at DailyMed

See drug prices for PROVENTIL

See drug sales revenues for PROVENTIL

Recent Clinical Trials for PROVENTIL

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

Sponsor	Phase
AstraZeneca	Phase 2
University Medical Center of Southern Nevada	N/A
West Penn Allegheny Health System	Phase 4

See all PROVENTIL clinical trials

US Patents and Regulatory Information for PROVENTIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Schering	PROVENTIL	albuterol	AEROSOL, METERED;INHALATION	017559-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Schering	PROVENTIL	albuterol sulfate	TABLET;ORAL	017853-002	May 7, 1982		DISCN	Yes	No
Schering	PROVENTIL	albuterol sulfate	SYRUP;ORAL	018062-001	Jan 19, 1983		DISCN	Yes	No
Kindeva	PROVENTIL-HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020503-001	Aug 15, 1996	AB1	RX	Yes	Yes
Schering	PROVENTIL	albuterol sulfate	SOLUTION;INHALATION	019243-002	Jan 14, 1987		DISCN	Yes	No
Schering	PROVENTIL	albuterol sulfate	SOLUTION;INHALATION	019243-001	Jan 14, 1987		DISCN	Yes	No
Schering	PROVENTIL	albuterol sulfate	TABLET;ORAL	017853-001	May 7, 1982		DISCN	Yes	No

Expired US Patents for PROVENTIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	PROVENTIL	albuterol sulfate	TABLET, EXTENDED RELEASE;ORAL	019383-001	Jul 13, 1987	3,644,353
Schering	PROVENTIL	albuterol sulfate	TABLET;ORAL	017853-002	May 7, 1982	3,644,353
Schering	PROVENTIL	albuterol sulfate	SOLUTION;INHALATION	019243-001	Jan 14, 1987	3,644,353
Schering	PROVENTIL	albuterol sulfate	SYRUP;ORAL	018062-001	Jan 19, 1983	4,499,108
Schering	PROVENTIL	albuterol	AEROSOL, METERED;INHALATION	017559-001	Approved Prior to Jan 1, 1982	3,644,353
Schering	PROVENTIL	albuterol sulfate	TABLET;ORAL	017853-002	May 7, 1982	3,705,233
Schering	PROVENTIL	albuterol sulfate	SYRUP;ORAL	018062-001	Jan 19, 1983	3,644,353

International Patents for PROVENTIL

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

Country	Patent Number	Title	Estimated Expiration
Germany	1643224
Cyprus	806	PHENYLAMINOETHANOL DERIVATIVES
Belgium	752892
Cyprus	713	Phenylaminoethanol derivatives
Netherlands	162897
Spain	381534
South Africa	7004414

PROVENTIL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Proventil (Albuterol Sulfate)

Introduction to Proventil

Proventil, known generically as albuterol sulfate, is a widely used bronchodilator for the treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms. It belongs to the class of beta-adrenergic bronchodilators, which dominate the bronchodilators market with a significant share.

Market Size and Growth Projections

The global albuterol sulfate market, which includes Proventil, is poised for substantial growth. Here are some key projections:

• The market was valued at USD 5.22 billion in 2023 and is expected to reach USD 9.14 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 8.32% during the forecast period[5].
• Another report indicates a market size of USD 2.38 billion in 2023, expected to reach USD 4.07 billion by 2031, growing at a CAGR of 7.1% from 2024 to 2031[5].

Key Drivers of Market Growth

Several factors are driving the growth of the albuterol sulfate market, including Proventil:

Increasing Prevalence of Respiratory Diseases

The rising incidence of respiratory disorders such as asthma, COPD, and bronchitis is a major driver. These conditions are becoming more prevalent due to factors like air pollution, urbanization, and lifestyle changes[5].

Advancements in Inhalation Therapy

Innovations in inhaler technology, including metered-dose and dry powder inhalers, are expanding treatment options and improving patient compliance. Regulatory approvals for generic formulations also contribute to market growth[5].

Growing Awareness and Diagnosis

Improved awareness and diagnostic techniques have led to earlier detection and better management of respiratory conditions. This increased diagnosis rate translates into higher demand for albuterol sulfate[5].

Regional Market Dynamics

North America

North America dominates the albuterol sulfate market, accounting for approximately 40% of the global market share. This is due to the region's robust healthcare infrastructure and high prevalence of respiratory disorders[5].

Global Expansion

The global bronchodilators market, including albuterol sulfate, is expected to grow at a CAGR of 3.29% from 2023 to 2030, reaching USD 28.75 billion by 2030. The U.S. market, in particular, is expected to expand at a CAGR of 2.91% during the same period[1].

Impact of COVID-19

The COVID-19 pandemic has had a significant impact on the respiratory drug market, including albuterol sulfate. The pandemic led to an increased burden on hospitals and healthcare professionals, and there was a heightened demand for respiratory medications.

• Off-Label Use: The COVID-19 outbreak saw the off-label use of bronchodilators, including albuterol sulfate, for inpatient treatment. This was due to the weakened lung and immune systems in patients, making them more susceptible to lung diseases and viral infections[1].
• Research and Development: Studies during the pandemic, such as those from the University of Oxford, highlighted the potential benefits of inhaled corticosteroids like budesonide in shortening recovery times for non-hospitalized COVID-19 patients. Although this specifically pertains to budesonide, it underscores the broader importance of respiratory medications during the pandemic[4].

Competitive Landscape

The market for albuterol sulfate is highly competitive, with several key players:

Generic Formulations

Companies like Cipla Limited have received final approvals for their Abbreviated New Drug Applications (ANDA) for generic versions of albuterol sulfate inhalation aerosols. Cipla’s Albuterol Sulfate Inhalation Aerosol is a generic therapeutic equivalent to Merck Sharp & Dohme Corp’s Proventil HFA Inhalation Aerosol[4].

Amneal Pharmaceuticals

Amneal Pharmaceuticals has also submitted ANDAs for complex generic products, including albuterol sulfate inhalation, which is expected to drive growth in the market[3].

Financial Performance and Projections

Revenue Forecast

The global bronchodilators market, which includes Proventil, is expected to reach USD 28.75 billion by 2030. The albuterol sulfate market specifically is projected to grow significantly, with revenues expected to reach USD 9.14 billion by 2030[1][5].

Cost Savings and Formulary Substitutions

Formulary substitutions, such as switching from metered-dose inhalers (MDIs) to nebulization solutions, can result in significant cost savings, despite additional costs for equipment and personnel. This trend is expected to continue, influencing the financial trajectory of the market[5].

Challenges and Considerations

Regulatory Framework

The market is heavily influenced by regulatory approvals and healthcare policies. Changes in these areas can impact the availability and affordability of albuterol sulfate medications[5].

Patient Compliance

Ensuring patient compliance with treatment regimens is crucial. Innovations in inhaler technology and patient education programs can help improve compliance rates, which in turn affect the market's financial performance[5].

Key Takeaways

• The albuterol sulfate market, including Proventil, is expected to grow significantly driven by increasing respiratory disease prevalence, advancements in inhalation therapy, and government initiatives.
• North America dominates the market due to its robust healthcare infrastructure and high prevalence of respiratory disorders.
• Generic formulations and formulary substitutions can lead to substantial cost savings.
• Innovations in delivery systems and combination therapies offer opportunities for market growth.
• Patient compliance and regulatory frameworks are critical factors influencing market dynamics.

FAQs

Q: What is the projected growth rate of the albuterol sulfate market? A: The market is expected to grow at a CAGR of 8.32% from 2023 to 2030, according to some reports, and at a CAGR of 7.1% from 2024 to 2031, according to others[5].

Q: Which region dominates the albuterol sulfate inhalation aerosol market? A: North America dominates the market, accounting for approximately 40% of the global market share due to its robust healthcare infrastructure and high prevalence of respiratory disorders[5].

Q: How can formulary substitutions impact costs? A: Formulary substitutions, such as switching from MDIs to nebulization solutions, can result in significant cost savings, despite additional costs for equipment and personnel[5].

Q: What factors influence the cost of albuterol sulfate? A: The cost is influenced by regulatory approvals, healthcare policies, and the availability of generic formulations[5].

Q: How has COVID-19 impacted the albuterol sulfate market? A: The pandemic led to increased demand for respiratory medications, including off-label use of bronchodilators, and highlighted the importance of respiratory treatments during the pandemic[1][4].

Citations

1. Grand View Research: Bronchodilators Market Size & Trends Analysis Report, 2030.
2. Alpha Spread: CIPLA Q4-2018 Earnings Call.
3. Amneal Pharmaceuticals: Amneal Submits Abbreviated New Drug Applications to U.S. FDA for Three Key Complex Generics.
4. Coherent Market Insights: Budesonide Inhaler Market Size and Trends.
5. Drug Patent Watch: Albuterol sulfate - Generic Drug Details.