VOLMAX Drug Patent Profile

When do Volmax patents expire, and when can generic versions of Volmax launch?

Volmax is a drug marketed by Muro and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Volmax

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

Summary for VOLMAX

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	133
Clinical Trials:	2
DailyMed Link:	VOLMAX at DailyMed

Recent Clinical Trials for VOLMAX

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

Sponsor	Phase
ALK-Abelló A/S	Phase 3
Merck Sharp & Dohme Corp.	Phase 3

See all VOLMAX clinical trials

US Patents and Regulatory Information for VOLMAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Muro	VOLMAX	albuterol sulfate	TABLET, EXTENDED RELEASE;ORAL	019604-002	Dec 23, 1992		DISCN	Yes	No
Muro	VOLMAX	albuterol sulfate	TABLET, EXTENDED RELEASE;ORAL	019604-001	Dec 23, 1992		DISCN	Yes	No

Expired US Patents for VOLMAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Muro	VOLMAX	albuterol sulfate	TABLET, EXTENDED RELEASE;ORAL	019604-002	Dec 23, 1992	4,751,071
Muro	VOLMAX	albuterol sulfate	TABLET, EXTENDED RELEASE;ORAL	019604-001	Dec 23, 1992	4,851,229
Muro	VOLMAX	albuterol sulfate	TABLET, EXTENDED RELEASE;ORAL	019604-001	Dec 23, 1992	4,751,071

International Patents for VOLMAX

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

Country	Patent Number	Title	Estimated Expiration
France	2555897	SYSTEME D'APPORT, A DEBIT CONSTANT ET A LIBERATION PULSEE, DE SUBSTANCES A UN MILIEU ENVIRONNANT
Italy	1179843	DISPOSITIVO OSMOTICO E PROCEDIMENTO PER L EROGAZIONE DI UN AGENTE BENEFICO PARTICOLARMENTE DI UN FARMACO AD UN AMBIENTE D USO
Italy	8468196

Market Dynamics and Financial Trajectory for VOLMAX

Last updated: July 31, 2025

Introduction

VOLMAX, a pharmaceutical compound marketed as a treatment for asthma and chronic obstructive pulmonary disease (COPD), has garnered significant attention within respiratory therapeutics. Understanding its market dynamics and financial trajectory involves analyzing current demand, competitive landscape, regulatory influence, patent status, pricing strategies, and broader healthcare trends. This comprehensive overview delves into factors shaping VOLMAX’s market presence and forecasts its financial potential.

Market Overview

Therapeutic Market Context

The global respiratory drugs market, encompassing asthma and COPD treatments, was valued at approximately USD 28 billion in 2022, with an expected compound annual growth rate (CAGR) of around 5.4% through 2030 [1]. This trajectory is driven by increasing prevalence of respiratory conditions, aging populations, and technological advancements in inhalation therapy.

Key Competitors and Product Landscape

VOLMAX operates amidst established competitors, notably GlaxoSmithKline’s Advair and AstraZeneca’s Symbicort. These products achieved broad market penetration through combining corticosteroids with long-acting beta-agonists. The competitive landscape is characterized by patent expirations, biosimilar entries, and emerging combination therapies that intensify market competition.

Market Entry and Positioning

As a newer entrant, VOLMAX’s success hinges on differentiating its efficacy, safety profile, and delivery mechanisms. If approved as a novel therapeutic, it may also leverage formulation innovations such as improved inhaler devices, which enhance patient adherence.

Regulatory and Patent Dynamics

Approval Status

VOLMAX’s regulatory pathway significantly influences its market entry and adoption. Approval by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) predicates early commercialization. The submission of Phase III data indicates progressing toward potential approval (anticipated in the next 12-18 months), contingent on demonstrating superior efficacy or safety.

Patent Landscape

Patent protection grants exclusivity, enabling premium pricing and market share retention. If VOLMAX’s patent covers its formulation, delivery device, or method of use, it secures a competitive advantage for 10–15 years post-approval [2]. Patent cliffs or infringements could lead to generic competition, affecting revenue streams.

Financial Trajectory

Revenue Projections

Initial sales estimates place VOLMAX’s revenue potential between USD 250–500 million within the first five years, contingent on approval speed, market penetration, and physician acceptance. Launch strategies involving direct-to-consumer advertising, physician education, and formulary positioning influence early adoption rates.

Pricing Strategy and Reimbursement

Premium pricing, aligned with innovative features or superior efficacy, can enhance margins. Reimbursement policies by major insurance payors and health authorities are critical. Favorable reimbursement decisions or inclusion in government formularies expand accessibility and sales volume.

Cost Structure and Profitability Outlook

Research & Development (R&D) expenses, manufacturing costs, and marketing expenditures shape profit margins. Economies of scale upon market entry improve profitability, with breakeven projected within 3–4 years, assuming moderate growth and sustained demand.

Market Expansion Opportunities

Beyond initial markets (U.S., EU), VOLMAX can target emerging economies where respiratory diseases are on the rise, boosting long-term growth prospects. Formulation variations for pediatric use or combination therapies can diversify revenue streams.

External Influences Impacting Financial Trajectory

Healthcare Trends and Demographic Shifts

Aging populations worldwide increase demand for chronic respiratory therapies. The rise of personalized medicine advocates for tailored treatments, potentially favoring VOLMAX if it offers customization or improved delivery.

Technological Innovations

Advances in inhaler device design, digital health integrations, and adherence monitoring could enhance VOLMAX’s competitiveness, expanding its market share.

Regulatory and Policy Changes

Evolving regulation around generics and biosimilars may shorten patent life or accelerate competition. Policy shifts toward value-based care influence pricing and reimbursement strategies.

Risks and Challenges

• Delayed Approval: Regulatory hurdles or requiring additional trials can postpone market entry, affecting revenue timing.
• Competitive Market Entry: Rapid generic proliferation can erode market share post-patent expiry.
• Pricing Pressures: Payer resistance to high drug prices could limit profitability.
• Manufacturing Complexities: Technical challenges in consistent drug delivery impact supply stability and acceptability.

Conclusion

The market dynamics for VOLMAX depend on regulatory milestones, competitive positioning, and healthcare system receptiveness. Its financial trajectory appears cautiously optimistic, with significant upside potential contingent on timely approval, strategic marketing, and innovative differentiation. Long-term success requires navigating patent landscapes, leveraging technological advancements, and responding to evolving healthcare policies.

Key Takeaways

• VOLMAX’s market success hinges on expedited regulatory approval and effective differentiation in a competitive respiratory therapy landscape.
• Securing and extending patent protection is pivotal to maintain exclusivity and premium pricing.
• Revenue growth is expected to follow strategic market entry, with an initial forecast of USD 250–500 million within five years.
• Broader healthcare trends, such as aging populations and digital health integration, amplify growth opportunities.
• External factors, including policy shifts and technological innovations, pose risks requiring proactive management.

FAQs

Q1: When is VOLMAX expected to receive regulatory approval?

A: Approval timelines depend on clinical trial outcomes; currently, VOLMAX is in late-phase trials with anticipated submission in the next 12-18 months.

Q2: How does patent protection influence VOLMAX’s market prospects?

A: Patent exclusivity delays generic competition, enabling premium pricing and market share permanence for approximately 10–15 years post-approval.

Q3: What are the primary competitors for VOLMAX in the respiratory drugs market?

A: Major competitors include Advair (GSK), Symbicort (AstraZeneca), and other combination inhalers targeting asthma and COPD.

Q4: What factors could hinder VOLMAX’s market growth?

A: Patent expirations, regulatory delays, high pricing resistance, and aggressive generic entry are key risks.

Q5: How can VOLMAX capitalize on emerging healthcare trends?

A: By integrating digital adherence tools, developing pediatric formulations, and expanding into emerging markets, VOLMAX can enhance its growth trajectory.

---

Sources

[1] MarketWatch. "Respiratory Drugs Market Size, Share & Trends Analysis," 2022.

[2] WIPO. "Patent Duration and Market Exclusivity in Pharmaceuticals," 2021.