PROVENTIL-HFA Drug Patent Profile

Which patents cover Proventil-hfa, and when can generic versions of Proventil-hfa launch?

Proventil-hfa is a drug marketed by Kindeva and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Proventil-hfa

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

Summary for PROVENTIL-HFA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	19
Patent Applications:	5,671
DailyMed Link:	PROVENTIL-HFA at DailyMed

Recent Clinical Trials for PROVENTIL-HFA

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-HFA clinical trials

Paragraph IV (Patent) Challenges for PROVENTIL-HFA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PROVENTIL-HFA	Inhalation Aerosol	albuterol sulfate	0.09 mg base per actuation	020503	1	2015-05-20

US Patents and Regulatory Information for PROVENTIL-HFA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Kindeva	PROVENTIL-HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020503-001	Aug 15, 1996	AB1	RX	Yes	Yes

Expired US Patents for PROVENTIL-HFA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kindeva	PROVENTIL-HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020503-001	Aug 15, 1996
Kindeva	PROVENTIL-HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020503-001	Aug 15, 1996
Kindeva	PROVENTIL-HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020503-001	Aug 15, 1996
Kindeva	PROVENTIL-HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020503-001	Aug 15, 1996
Kindeva	PROVENTIL-HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020503-001	Aug 15, 1996
Kindeva	PROVENTIL-HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020503-001	Aug 15, 1996

International Patents for PROVENTIL-HFA

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

Country	Patent Number	Title	Estimated Expiration
Australia	5075596
Mexico	9102764	DISPOSITIVO PARA SURTIR AEROSOL.
Japan	H06504307
Japan	3260752
South Africa	9110143
New Zealand	241170	DEVICE FOR DELIVERING AN AEROSOL HAVING A VALVE STEM PASSING THROUGH A DIAPHRAGM COMPRISING A BLEND OF THERMOPLASTIC ELASTOMER WHICH IS MORE THAN 80% ETHYLENE POLYMER BLENDS, SEALS PREPARED THEREFROM

Market Dynamics and Financial Trajectory for Proventil HFA

Overview of Proventil HFA

Proventil HFA is a bronchodilator medication used to treat or prevent bronchospasm, primarily in patients with asthma or chronic obstructive pulmonary disease (COPD). It contains the active ingredient albuterol, a beta-2 agonist, and is delivered via a metered-dose inhaler (MDI) using hydrofluoroalkane (HFA) as the propellant.

Market Size and Growth

The global bronchodilators market, which includes Proventil HFA, was estimated to be USD 22.19 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 3.29% from 2023 to 2030, reaching USD 28.75 billion by 2030[1].

Segment Dominance

Beta-adrenergic bronchodilators, the class to which Proventil HFA belongs, dominated the market with a 41.15% share in 2022. This class includes short-acting beta-2 agonists like albuterol, which are crucial for quick relief from bronchospasm[1].

Revenue Impact of Patents

The revenue generated by Proventil HFA and similar inhalers is significantly influenced by patent status. Manufacturers earned substantial revenue during the periods when primary and secondary patents were active. For instance, between 2000 and 2021, manufacturers earned $67.2 billion when primary patents were active and $110.3 billion when only secondary patents were active. This highlights the financial benefits of extended patent protection[2].

Transition from CFC to HFA Inhalers

The transition from chlorofluorocarbon (CFC) to HFA inhalers, mandated by the FDA due to environmental concerns, has been a critical factor in the financial trajectory of Proventil HFA. The FDA's ban on CFC inhalers starting in 2009 led to increased sales of HFA-containing inhalers like Proventil HFA. This transition generated approximately $15 billion in U.S. sales between 2007 and 2021, as manufacturers benefited from the lack of generic competition during this period[3].

Sales Performance

Before the transition to HFA inhalers, annual revenue from brand-name albuterol inhalers was declining, dipping below $200 million in the early 2000s. However, with the increased uptake of HFA devices, sales rebounded to over $1 billion per year by 2010 and remained above this mark for the entire decade. This significant increase in sales was driven by the absence of generic HFA-containing albuterol inhalers during this period[3].

Licensing and Distribution

In recent years, Sandoz Inc. has acquired the commercial distribution rights to both the brand and authorized generic versions of Proventil HFA. This move is expected to impact the market dynamics by potentially increasing accessibility and reducing costs for patients, although it may also affect the revenue streams of the original manufacturer[5].

Environmental Impact and Regulatory Considerations

The use of HFA propellants in inhalers like Proventil HFA has environmental implications, as these propellants are greenhouse gases. Regulatory bodies, such as the EPA, monitor the sales and environmental impact of these products. The EPA estimates that HFCs in MDIs account for a small percentage of total HFC use but are still a consideration in broader environmental policies[4].

Competitive Landscape

The bronchodilators market is highly competitive, with several major players. Proventil HFA competes with other albuterol-based products like Ventolin HFA and ProAir HFA. The competitive landscape is further complicated by the presence of other types of bronchodilators, such as anticholinergics and combination products like Advair and Spiriva[1].

Patient Access and Healthcare Spending

Delays in generic competition, often due to secondary patents, have reduced patient access to affordable alternatives and led to unnecessary healthcare spending. The financial burden on patients and healthcare systems is a significant concern, as seen in the substantial revenue earned by manufacturers during periods of patent protection[2].

Future Outlook

The future financial trajectory of Proventil HFA will be influenced by several factors, including the availability of generic alternatives, changes in regulatory policies, and advancements in inhaler technology. As generic HFA-containing albuterol inhalers become more widely available, the revenue from brand-name products is expected to decline. However, the overall market for bronchodilators is projected to continue growing, driven by increasing prevalence of respiratory diseases and advancements in treatment options[1].

Key Takeaways

• Market Growth: The global bronchodilators market is expected to grow at a CAGR of 3.29% from 2023 to 2030.
• Patent Impact: Extended patent protection significantly influences revenue for products like Proventil HFA.
• Transition to HFA: The transition from CFC to HFA inhalers has been financially beneficial for manufacturers.
• Licensing and Distribution: Recent licensing agreements may impact market dynamics and patient access.
• Environmental Considerations: HFA propellants have environmental implications that are monitored by regulatory bodies.
• Competitive Landscape: The market is highly competitive with several major players and product types.

FAQs

What is the projected market size for bronchodilators by 2030?

The global bronchodilators market is expected to reach USD 28.75 billion by 2030[1].

How has the transition from CFC to HFA inhalers affected Proventil HFA sales?

The transition generated approximately $15 billion in U.S. sales between 2007 and 2021, significantly boosting revenue for Proventil HFA and similar products[3].

Who recently acquired the commercial distribution rights to Proventil HFA?

Sandoz Inc. acquired the commercial distribution rights to both the brand and authorized generic versions of Proventil HFA[5].

What is the environmental impact of HFA propellants in inhalers?

HFCs in MDIs account for a small percentage of total HFC use but are still a consideration in broader environmental policies[4].

How do patents affect the revenue of inhaler manufacturers?

Extended patent protection allows manufacturers to earn significant revenue, with $110.3 billion earned after primary patents expired but when secondary patents were active[2].