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-three 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
Patent Applications:	4,188
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	019604-001	Dec 23, 1992
Muro	VOLMAX	albuterol sulfate	TABLET, EXTENDED RELEASE;ORAL	019604-002	Dec 23, 1992
Muro	VOLMAX	albuterol sulfate	TABLET, EXTENDED RELEASE;ORAL	019604-001	Dec 23, 1992
Muro	VOLMAX	albuterol sulfate	TABLET, EXTENDED RELEASE;ORAL	019604-001	Dec 23, 1992
Muro	VOLMAX	albuterol sulfate	TABLET, EXTENDED RELEASE;ORAL	019604-002	Dec 23, 1992
Muro	VOLMAX	albuterol sulfate	TABLET, EXTENDED RELEASE;ORAL	019604-002	Dec 23, 1992

International Patents for VOLMAX

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

Country	Patent Number	Title	Estimated Expiration
United Kingdom	2150434	CONSTANT RATE RELEASE SYSTEMS
Spain	293000
Japan	H0733642	COMPOSITION USED FOR OSMOTIC PRESSURE DELIVERY DEVICE
Italy	8468196
Canada	1251708	SYSTEME DE DISPENSION CONSTANTE A MODULATION PULSEE (CONSTANT RELEASE SYSTEM WITH PULSED RELEASE)
Japan	2683493
Italy	1179843	DISPOSITIVO OSMOTICO E PROCEDIMENTO PER L EROGAZIONE DI UN AGENTE BENEFICO PARTICOLARMENTE DI UN FARMACO AD UN AMBIENTE D USO

VOLMAX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Pharmaceutical Industry: Insights Relevant to Drugs Like VOLMAX

Introduction

The pharmaceutical industry is undergoing significant transformations driven by various market dynamics, technological advancements, and changing regulatory landscapes. To understand the potential market dynamics and financial trajectory for a drug like VOLMAX, it is crucial to analyze the broader trends affecting the industry.

Market Competition and Consolidation

The pharmacy market, in particular, has seen increased consolidation and vertical integration, which can impact the competitive landscape for new drugs. Independent pharmacies face rising challenges, while specialty pharmacies and mail-order pharmacies are gaining traction[1].

Generic Drugs Market

The generics market is expected to grow significantly, driven by patent expirations and increasing demand. By 2025, the generics market could reach $497 billion, with a compound annual growth rate (CAGR) of 5.4%[4].

Brand-Name Medicines

Brand-name medicines continue to drive revenue for pharmaceutical companies. For example, Servier Group's brand-name medicine revenue increased by 9.4% to €4.041 billion in the 2022-2023 financial year, despite currency fluctuations and other challenges[2].

Specialty Drugs

Specialty drugs, including those for chronic conditions like obesity and diabetes, are becoming increasingly important. The GLP-1 market, for instance, is projected to grow from $10 billion to $100 billion by 2030, driven by expanding patient populations and broader therapeutic applications[3].

Financial Performance Metrics

Pharmaceutical companies are focusing on strong financial performance metrics, including revenue growth, EBITDA margins, and net income. For example, Halozyme reported a 17% to 23% growth in total revenue for 2024, driven by increases in royalty revenue, collaboration revenue, and product sales[5].

Revenue Growth Drivers

Several factors drive revenue growth in the pharmaceutical sector:

• Sales Volume: Increased sales volumes of brand-name and generic medicines contribute significantly to revenue growth. Servier Group's revenue grew by 9.2% due to an 11.4% increase in sales volumes[2].
• Royalty Revenue: Royalties from licensed products can be a substantial revenue stream. Halozyme expects royalty revenue to grow by 23% to 26% in 2024[5].
• Collaboration Revenue: Partnerships and collaborative agreements can also drive revenue. Halozyme's revenue under collaborative agreements increased significantly in 2024[5].

Cost Control and Profitability

Tight cost control is essential for maintaining profitability. Servier Group's EBITDA margin increased to 19.1% in the 2022-2023 financial year, largely due to higher sales and effective cost management[2].

Regulatory and Market Access

Regulatory approvals and market access are critical for the success of any drug. The FDA's approval of GLP-1 drugs for additional indications, such as the prevention of heart disease, can significantly expand their market[3].

Patient Population and Market Size

The potential market size for a drug is heavily influenced by the size of the patient population and the drug's therapeutic applications. The GLP-1 market, for example, could see its patient population grow from 2 million to 15 million by 2030, driven by expanded coverage and new indications[3].

Pricing and Competition

Pricing strategies and competition play a crucial role in the pharmaceutical market. Generic drugs are typically priced between 30% and 90% of their branded counterparts, and consolidated buyers can exert significant price pressure[4].

Emerging Markets

International revenue, particularly from emerging markets, is becoming increasingly important. Servier Group's international revenue outside the European Union accounted for 56.6% of its consolidated revenue, with significant growth in the American continent[2].

Research and Development

Investment in research and development (R&D) is vital for innovation and future growth. Halozyme's R&D expenses increased due to higher compensation and other costs, reflecting the company's commitment to innovation[5].

Financial Outlook

Companies are continually updating their financial guidance based on market performance. Halozyme raised its financial guidance for 2024, expecting total revenue to grow by 17% to 23% and adjusted EBITDA to grow by 40% to 47%[5].

Key Takeaways

• Market Consolidation: Increased consolidation and vertical integration are shaping the pharmacy market.
• Generic Drugs Growth: The generics market is expected to reach $497 billion by 2025.
• Specialty Drugs: Specialty drugs, such as GLP-1s, are seeing significant growth due to expanded therapeutic applications.
• Financial Performance: Strong revenue growth, tight cost control, and high EBITDA margins are key to profitability.
• Regulatory Approvals: FDA approvals for new indications can significantly expand a drug's market.
• Pricing Strategies: Pricing and competition, especially in the generics market, are critical factors.

FAQs

Q: How is the generics market expected to grow in the coming years? A: The generics market is projected to grow at a CAGR of 5.4%, reaching $497 billion by 2025, driven by patent expirations and increasing demand[4].

Q: What factors are driving the growth of the GLP-1 market? A: The GLP-1 market is driven by expanding patient populations, broader therapeutic applications, and potential increases in private and public insurance coverage[3].

Q: How important is cost control for pharmaceutical companies? A: Tight cost control is essential for maintaining profitability, as seen in Servier Group's increased EBITDA margin due to effective cost management[2].

Q: What role do emerging markets play in the pharmaceutical industry? A: Emerging markets, particularly outside the European Union, are becoming increasingly important, with significant revenue growth in regions like the American continent[2].

Q: How do regulatory approvals impact the market for new drugs? A: Regulatory approvals, such as FDA approvals for new indications, can significantly expand a drug's market and increase its revenue potential[3].

Sources

1. Commonwealth Fund - "Competition, Consolidation, and Evolution in the Pharmacy Market"
2. Servier - "Servier confirms its 2025 trajectory to achieve its 2030 ambition"
3. Goldman Sachs - "Weighing the GLP-1 market"
4. KPMG International - "Generics 2030"
5. Halozyme - "Halozyme Reports Third Quarter 2024 Financial and Operating Results"