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-seven 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

Expired US Patents for PROVENTIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	PROVENTIL	albuterol sulfate	TABLET;ORAL	017853-002	May 7, 1982
Schering	PROVENTIL	albuterol sulfate	TABLET;ORAL	017853-001	May 7, 1982
Schering	PROVENTIL	albuterol sulfate	SOLUTION;INHALATION	019243-001	Jan 14, 1987
Schering	PROVENTIL	albuterol	AEROSOL, METERED;INHALATION	017559-001	Approved Prior to Jan 1, 1982

International Patents for PROVENTIL

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

Country	Patent Number	Title	Estimated Expiration
Austria	280996
Austria	300763
Belgium	704037
Belgium	752892

Proventil (albuterol sulfate) Market Dynamics and Financial Trajectory: Launch Drivers, Competitive Pressure, Exclusivity vs. Generics, and Revenue Risk

Last updated: July 4, 2026

Proventil’s financial trajectory is dominated by generic competition across albuterol sulfate metered-dose inhalers (MDIs), with pricing pressure tracking broader respiratory generic dynamics. Brand-level revenue is largely a legacy story: today’s market is defined by low-cost generics, pharmacy channel substitution, and contracting forces in payor formularies, not by sustained brand differentiation.

What is Proventil (albuterol sulfate) and how does it make money in today’s respiratory market?

Proventil is an albuterol sulfate rescue bronchodilator for acute bronchospasm in asthma and related conditions. Commercial performance is tied to:

• Inhaled short-acting beta-agonist (SABA) demand trends
• Formulary placement and pharmacy contract pricing
• Substitution from lower-cost albuterol generics and AB-rated products
• Share shifts between MDIs vs. alternative inhaler formats (where applicable)

Current market structure (high level)

• Albuterol SABA is a mature, high-availability category with multiple FDA-approved alternatives and extensive generic penetration.
• Brand economics tend to compress quickly once generic MDIs establish broad coverage and price leadership in pharmacy channels.

How do generics and AB-rated substitution affect Proventil revenue?

Core dynamic Once generic albuterol MDIs are widely available, Proventil competes primarily on list price and net price after rebates, discounts, and pharmacy channel contracts. For payors, AB substitution usually makes brand premiums hard to sustain.

Typical impacts

• Gross-to-net erosion from competitive rebates becomes structurally higher
• Net revenue per unit declines even if units stabilize
• Share loss accelerates when a dominant generic wins formulary positioning or pharmacy class purchasing

Business consequence Brand revenue becomes increasingly dependent on:

• Contract retention and rebate economics
• Litigation outcomes that delay certain generic entries (if any remain at the product level)
• Differences in device/formulation that map to distinct product codes (where applicable)

What timelines determine when Proventil loses exclusivity?

Exclusivity framework For small-molecule inhaled products like albuterol sulfate, the decisive levers are:

• Patent term for active ingredient and specific compositions/formulations
• Patent term adjustments and exclusivity for any later-developed product-specific changes
• Launch protection or “first generic” risk depending on patent landscape

Commercial reality in mature SABAs For legacy brands in an extensively generified therapeutic class, exclusivity is usually not the primary determinant of long-run revenue. The market instead follows generic entry, pricing, and contracting cycles.

What patents protect Proventil and how does that affect generic entry risk?

A full patent landscape requires exact product identification (labeling, dosage strength, device type, and application type), plus Orange Book mapping to active patents and exclusivity codes. Without that product-level mapping, a complete and accurate “which patents protect Proventil” answer cannot be produced.

What is the Orange Book status of Proventil?

A definitive Orange Book status also requires product-specific Orange Book listings (application number, drug product listing IDs, and the currently listed patents/exclusivity). Without exact Orange Book entries for the specific Proventil presentation being evaluated, the Orange Book status cannot be stated completely and accurately.

What generic entry risks exist for Proventil and how do Paragraph IV filings matter?

Paragraph IV risk is measured by:

• Identified Orange Book-listed patents
• Whether an ANDA challenges one or more listed patents
• Whether litigation triggers 30-month stays or later settlement “design-arounds”

A complete answer needs Orange Book-anchored patent lists and litigation dockets tied to those listings. Without those anchors, an accurate “generic entry risks” assessment cannot be produced.

How does Proventil compare with other albuterol brands and authorized generics?

Competitive set Inhaled albuterol MDIs and other SABA rescue therapies compete on:

• Price and net cost (AB substitution)
• Availability and distribution
• Prescriber familiarity and device usability
• Contract coverage across payer tiers

Practical outcome In a mature SABA market, competitive advantage usually narrows to reimbursement and channel economics. Device or formulation changes can create short-lived differentiation, but economic advantage often compresses quickly when generics match the AB-rating.

What litigation or settlements have shaped Proventil’s financial trajectory?

Patent litigation outcomes can affect launch timing and revenue windows. A complete litigation-and-settlement analysis requires:

• Case listings tied to Proventil’s specific patents and Orange Book entries
• Settlement agreements’ effective dates and any authorized generic provisions

Without product-tied patent and docket data, the litigation impact cannot be stated accurately.

How does FDA regulatory status influence Proventil’s market performance?

FDA status affects market performance through:

• Shelf-stable supply and manufacturing continuity
• Labeling constraints and any safety-related changes
• Approval scope across strengths and dosage forms

A complete regulatory performance assessment again requires the specific Proventil product labeling and current FDA status for the relevant application(s). Without that, a fully accurate regulatory analysis cannot be produced.

What are the key commercial drivers for Proventil demand?

Even in generics-led markets, demand is shaped by:

• Asthma prevalence and severity mix in the treated population
• SABA prescribing patterns and guideline adherence
• Acute respiratory seasonality (Q1 to Q3 peaks often show up in respiratory categories, depending on geography and reporting method)
• Switch behavior from SABA-only vs. controller-dependent regimens

What pricing dynamics should be expected for Proventil in a generics-dominant class?

Expected direction

• Net price declines after generic entry
• Unit volumes can remain stable or decline depending on guideline shifts and channel substitution
• Rebates rise to defend formulary placement, reducing net profitability

Channel effects

• Pharmacy benefit managers often steer to lowest net-cost AB equivalents
• Wholesaler and contract purchasing determines effective realized pricing

How much revenue exposure does Proventil have versus competitors in albuterol?

A quantified exposure assessment requires:

• Proventil brand revenue history and attribution to product presentations
• Competitor revenue by molecule and dosage form
• Market share by payer segment and channel

Without that dataset, a numeric revenue exposure analysis cannot be produced.

What is the investment and licensing outlook for Proventil-like SABA assets?

For mature SABAs:

• Licensing opportunities typically focus on lifecycle management (device IP, formulation IP, labeling differentiation, and manufacturing process IP)
• Commercial upside is limited by AB substitution and fast generic capture
• The best economics often come from owning a differentiating presentation that is hard to replicate or from controlling a manufacturing bottleneck

A precise Proventil-specific licensing outlook requires current product-level patent and exclusivity mapping and any known device or formulation IP differentiators.

Key Takeaways

• Proventil’s financial trajectory is constrained by the structural economics of mature SABA markets where AB-rated generics dominate.
• Long-term revenue pressure is primarily pricing and contracting driven, not growth-driven.
• Exclusivity and litigation matter mainly for short windows around product-specific patent challenges; class-level generic dynamics usually dominate after entry.
• A complete patent, Orange Book, Paragraph IV, and litigation risk assessment requires product-specific mapping to FDA listings and case dockets, which is not provided here.

FAQs

1. Why do albuterol MDI brands lose revenue quickly after generic launches?
   AB-rated substitution and net-price compression through payer and pharmacy contracting typically erode brand premiums rapidly.

2. Do formulation or device changes protect Proventil-like SABA products longer than active ingredient patents?
   They can, if they create distinct FDA-licensed drug products tied to enforceable patents, but protection is often narrow and short-lived in practice.

3. How do PBM formularies affect Proventil versus generic albuterol?
   PBMs usually steer to lowest net-cost AB equivalents, reducing brand retention unless the brand secures favorable tier placement through rebates.

4. What metrics best track Proventil’s commercial health?
   Net revenue, units by NDC/presentation, realized price trends, and formulary share by payer segment.

5. What category shifts could reduce overall SABA use and impact Proventil volumes?
   Guideline trends favoring controller-based management can lower rescue reliance, changing total SABA demand growth even if rescue indications remain.

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References

No sources were cited because no product-specific Orange Book listings, FDA application identifiers, patent numbers, litigation dockets, or financial figures for Proventil were provided in the prompt.