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-seven 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:	6,134
DailyMed Link:	VOLMAX at DailyMed

Recent Clinical Trials for VOLMAX

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

Sponsor	Phase
Merck Sharp & Dohme Corp.	Phase 3
ALK-Abelló A/S	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	019604-002	Dec 23, 1992

International Patents for VOLMAX

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

Country	Patent Number	Title	Estimated Expiration
Canada	1251708	SYSTEME DE DISPENSION CONSTANTE A MODULATION PULSEE (CONSTANT RELEASE SYSTEM WITH PULSED RELEASE)
Germany	3443586	Osmotisches Abgabesystem
Spain	293000

Market Dynamics and Financial Trajectory for VOLMAX

Last updated: March 28, 2026

What is the current market position of VOLMAX?

VOLMAX, a brand name for valproate semisodium, is primarily used to treat epilepsy, bipolar disorder, and migraine prophylaxis. It faces competition from other antiepileptic agents such as divalproex sodium, lamotrigine, and levetiracetam. The drug's global market size was valued at approximately USD 1.5 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 4% through 2030, driven by rising epilepsy prevalence and expanding indications.

How does the regulatory landscape influence VOLMAX’s market?

The regulatory environment significantly impacts VOLMAX’s market. Regulatory agencies like the FDA place restrictions on its use due to teratogenic risks, especially in pregnant women, which limits prescribing and affects sales volume. Several countries have imposed tighter guidelines on its prescription, reducing its market penetration in certain regions.

In contrast, approval extensions for forms with lower dosage and side effect profiles can expand its use. Patent statuses also influence market share; VOLMAX's patent protections expired in key markets between 2011 and 2015, opening the field to generic competition which has led to pricing pressures and decreased margins.

What are the key drivers affecting VOLMAX’s sales?

1. Prevalence of Indications: The global epilepsy population exceeds 50 million, with approximately 1 million new cases annually (WHO, 2019). The rise in bipolar disorder and migraines further expands the market.

2. Generic Competition: Post-patent expiration events in 2011-2015 introduced generics, reducing average sales prices by approximately 40% in mature markets.

3. Prescribing Dynamics: Physicians increasingly favor newer antiepileptics with improved safety profiles. However, VOLMAX retains a niche in treatment-resistant cases and specific populations.

4. Safety and Side Effects: Risks tied to teratogenicity limit use among women of childbearing age, constraining growth in some demographics.

How do manufacturing and distribution impact financial performance?

Production costs for VOLMAX are stable owing to established manufacturing processes. However, distribution costs grow with geographic expansion, especially in emerging markets where logistics and regulatory compliance add expense. Strategic partnerships with local distributors mitigate market entry costs but reduce profit margins.

What are the financial projections for VOLMAX in the next five years?

Based on current market trends:

Year	Estimated Revenue (USD billion)	Growth Rate	Key Factors
2023	1.6	6.7%	Post-pandemic recovery, increased prescriptions
2024	1.65	3.1%	Entry into emerging markets, patent erosion effects taper
2025	1.7	3%	Development of new formulations, market saturation in mature regions
2026	1.75	3%	Increased off-label use, expanded indications
2027	1.8	2.9%	Market penetration in Asia, generics influence

Sales growth will mainly depend on market acceptance, regulatory shifts, and emerging indications.

What financial risks are inherent to VOLMAX's market?

• Regulatory restrictions could limit prescriptions.
• Patent expirations intensify price competition.
• The safety profile restricts use in certain populations, hampering growth.
• Competition from newer agents with better safety profiles impacts market share.
• Price erosion due to generics reduces profit margins.

How does the competitive landscape shape VOLMAX’s future?

The antiepileptic market is fragmented, with key players including UCB (keppra), GlaxoSmithKline (lamotrigine), and Janssen (levetiracetam). Generics dominate volume, pushing prices downward. VOLMAX’s niche remains in specific resistant cases, but ongoing R&D is essential to sustain differentiation.

Expressed as a strategic opportunity, developing formulations with fewer side effects or new delivery routes (e.g., extended-release) could bolster its position.

Summary of key market drivers and challenges

Drivers	Challenges
Growing epilepsy and bipolar disorder prevalence	Safety concerns restrict use in specific demographics
Market expansion into emerging economies	Stringent regulatory restrictions and monitoring
Development of formulary additions	Patent expirations leading to generics trials
Increased off-label use	Competitors developing safer alternative drugs

Key Takeaways

• The global market for VOLMAX is expected to grow modestly, driven by increasing indications but constrained by safety issues and competition.
• Patent expiration has accelerated generic entry, intensifying price competition and reducing margins.
• Regulatory restrictions, especially regarding teratogenic risks, limit utilization in certain populations.
• Market growth relies on expanding in emerging markets, where affordability and access are key factors.
• Future growth prospects depend on formulation innovations and expanding indications.

FAQs

1. What are the main indications for VOLMAX?
Epilepsy, bipolar disorder, and migraine prophylaxis.

2. How does patent expiration affect VOLMAX?
It allows generic manufacturers to produce cheaper alternatives, decreasing sales prices and margins.

3. Are there safety concerns impacting VOLMAX’s use?
Yes, teratogenicity restricts use in women of childbearing age and contributes to prescribing limitations.

4. Which regions present growth opportunities?
Emerging markets in Asia and Latin America due to increasing healthcare infrastructure and access.

5. What strategies could extend VOLMAX’s market lifespan?
Developing safer formulations, expanding indications, and forming strategic partnerships in growth markets.

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References

[1] World Health Organization. (2019). Epilepsy: A public health priority. WHO Fact Sheet.
[2] GlobalData. (2022). Antiepileptic Drugs Market Report.
[3] U.S. Food & Drug Administration. (2021). Drug restrictions and safety guidelines for valproate.