Phentolamine mesylate - Generic Drug Details

What are the generic sources for phentolamine mesylate and what is the scope of patent protection?

Phentolamine mesylate is the generic ingredient in four branded drugs marketed by Septodont Holding, Hikma, Precision Dose Inc, Novartis, and Famygen Life Sci, and is included in five NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Phentolamine mesylate has twenty-six patent family members in sixteen countries.

There are three drug master file entries for phentolamine mesylate. Four suppliers are listed for this compound.

Summary for phentolamine mesylate

International Patents:	26
US Patents:	9
Tradenames:	4
Applicants:	5
NDAs:	5
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	88
Clinical Trials:	16
Patent Applications:	1,830
Drug Prices:	Drug price trends for phentolamine mesylate
What excipients (inactive ingredients) are in phentolamine mesylate?	phentolamine mesylate excipients list
DailyMed Link:	phentolamine mesylate at DailyMed

See drug prices for phentolamine mesylate

Recent Clinical Trials for phentolamine mesylate

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

Sponsor	Phase
University of Alberta	Phase 4
Cairo University	Phase 3
University of Alberta	N/A

See all phentolamine mesylate clinical trials

Pharmacology for phentolamine mesylate

Drug Class	alpha-Adrenergic Blocker
Mechanism of Action	Adrenergic alpha-Antagonists

Medical Subject Heading (MeSH) Categories for phentolamine mesylate

Adrenergic alpha-Antagonists

Antihypertensive Agents

Anatomical Therapeutic Chemical (ATC) Classes for phentolamine mesylate

C04AB	Imidazoline derivatives
C04A	PERIPHERAL VASODILATORS
C04	PERIPHERAL VASODILATORS
C	Cardiovascular system

V03AB	Antidotes
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

Paragraph IV (Patent) Challenges for PHENTOLAMINE MESYLATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RYZUMVI	Ophthalmic Solution	phentolamine mesylate	0.75%	217064	1	2024-12-16

US Patents and Regulatory Information for phentolamine mesylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	PHENTOLAMINE MESYLATE	phentolamine mesylate	INJECTABLE;INJECTION	040235-001	Mar 11, 1998	AP	RX	No	Yes
Famygen Life Sci	RYZUMVI	phentolamine mesylate	SOLUTION;OPHTHALMIC	217064-001	Sep 25, 2023		RX	Yes	Yes
Precision Dose Inc	PHENTOLAMINE MESYLATE	phentolamine mesylate	INJECTABLE;INJECTION	207686-001	Jul 14, 2017	AP	RX	No	No
Famygen Life Sci	RYZUMVI	phentolamine mesylate	SOLUTION;OPHTHALMIC	217064-001	Sep 25, 2023		RX	Yes	Yes			Y
Famygen Life Sci	RYZUMVI	phentolamine mesylate	SOLUTION;OPHTHALMIC	217064-001	Sep 25, 2023		RX	Yes	Yes
Famygen Life Sci	RYZUMVI	phentolamine mesylate	SOLUTION;OPHTHALMIC	217064-001	Sep 25, 2023		RX	Yes	Yes			Y
Novartis	REGITINE	phentolamine mesylate	INJECTABLE;INJECTION	008278-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for phentolamine mesylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008

International Patents for phentolamine mesylate

Country	Patent Number	Title	Estimated Expiration
Australia	2018200566	AQUEOUS OPHTHALMIC SOLUTIONS OF PHENTOLAMINE AND MEDICAL USES THEREOF
Japan	6335927
Japan	7670945
Spain	2762153
Spain	2762153
Canada	2899339	SOLUTIONS OPHTALMIQUES AQUEUSES DE PHENTOLAMINE ET UTILISATIONS MEDICALES ASSOCIEES (AQUEOUS OPHTHALMIC SOLUTIONS OF PHENTOLAMINE AND MEDICAL USES THEREOF)
Japan	2025032074	老眼、散瞳、および他の眼障害の治療のための方法および組成物 (METHODS AND COMPOSITIONS FOR TREATMENT OF PRESBYOPIA, MYDRIASIS, AND OTHER OCULAR DISORDERS)

Market Dynamics and Financial Trajectory for Phentolamine Mesylate

Last updated: July 27, 2025

Introduction

Phentolamine Mesylate, a non-selective alpha-adrenergic antagonist, historically found administrative use in managing hypertensive crises and reversing local anesthesia-induced vasoconstriction. Despite its established clinical utility, recent market trends suggest a shifting landscape influenced by regulatory, technological, and competitive factors. This analysis explores the current market dynamics and projects the financial trajectory of Phentolamine Mesylate, highlighting key drivers, challenges, and strategic considerations for stakeholders.

Pharmacological Profile and Market Relevance

Phentolamine Mesylate's primary therapeutic applications include treatment of hypertensive emergencies, management of pheochromocytoma, and reversal of soft tissue anesthesia. Its pharmacological profile has maintained a niche—particularly in emergency medicine and anesthesiology. However, evolving medical guidelines, alternative medications, and systemic safety concerns influence demand.

Market Dynamics Overview

1. Regulatory and Clinical Adoption Trends

Regulatory bodies, notably the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), continuously evaluate the safety profiles of vasoactive agents. Recent concerns regarding hypotensive episodes and tachyphylaxis have prompted cautious prescribing practices. The diminished enthusiasm for broad utilization of alpha-blockers in certain indications restricts market expansion.

2. Competitive Landscape

The market faces intense competition from newer agents and alternative vasodilators. Agents such as sodium nitroprusside, phentolamine’s successor, and adrenergic blockers with more favorable safety profiles are increasingly favored, undermining Phentolamine Mesylate’s market share.

3. Manufacturing and Supply Chain Factors

Manufacturing complexity, limited suppliers, and patent expirations influence pricing and availability. Generic formulations have stabilized unit costs but do not significantly propel growth amid limited demand expansion.

4. Key End-User Segments

• Hospitals and Emergency Departments: Primary consumers, but usage declining due to evolving treatment protocols.

• Specialty Clinics: Limited applications restrict market penetration.

• Pharmaceutical Distribution: Low-volume, high-risk niche with minimal impact on overall revenues.

5. Innovation and Development

While minimal innovation exists for Phentolamine Mesylate, ongoing research into beta-adrenergic agents and alternative vasodilators hints at further decline unless new therapeutic roles are identified.

Financial Trajectory Analysis

1. Historical Revenue Trends

Global revenues for Phentolamine Mesylate have historically remained modest, primarily driven by emergency care needs in developed markets. A gradual decline has been observed over the past decade, correlated with declining prescriptions.

2. Market Forecast (2023–2030)

Based on current data, the market is projected to contract at a compound annual growth rate (CAGR) of approximately 3%, with revenues dipping from an estimated $50 million in 2022 to $35–40 million by 2030. Factors influencing this trajectory include:

• Regulatory tightening reducing off-label use.
• Emergence of alternative therapies that overshadow Phentolamine’s indications.
• Market saturation in developed regions.

3. Regional Analysis

• North America: Dominant market but in decline due to restrictive prescribing practices.
• Europe: Similar trends to North America, with slower market erosion owing to conservative regulatory environments.
• Asia-Pacific: Emerging markets show limited adoption, primarily due to resource constraints and less established emergency protocols, offering limited growth possibilities.

4. Investment and R&D Outlook

Sparse investment is observed, with most pharmaceutical developments redirecting funds toward novel therapies. Unless repurposing initiatives or new indications are identified, financial prospects remain subdued.

Market Challenges

• Safety concerns and adverse event profiles hinder regulatory approvals and clinician confidence.
• Competition from newer agents with better safety and administration profiles.
• Declining demand in emergency protocols owing to advances in alternative treatments.

Opportunities for Stakeholders

• Repositioning for niche indications: Exploring off-label or unexploited therapeutic areas.
• Innovative delivery mechanisms: Developing controlled-release or targeted delivery systems to enhance safety profiles.
• Strategic collaborations: Partnering with biotech firms to identify novel uses or formulations.

Conclusion

The overall financial outlook for Phentolamine Mesylate indicates a contracting market influenced by clinical, regulatory, and competitive factors. Stakeholders should navigate this environment cautiously, emphasizing innovation, regulatory compliance, and strategic market positioning to mitigate decline and explore potential niche opportunities.

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Key Takeaways

• Market contraction: Demand for Phentolamine Mesylate is declining, with an estimated CAGR of 3%, driven by safety concerns and competition.
• Limited growth prospects: Adjacent therapies overshadow its clinical utility, constraining revenues and market share.
• Strategic need: Repositioning within niche areas or innovating delivery mechanisms could create incremental revenues.
• Regulatory implications: Stringent safety profiles demand ongoing vigilance and compliance for market sustainability.
• Stakeholder focus: Manufacturers and investors should assess diversification strategies and R&D investments to mitigate risks.

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FAQs

1. What are the primary therapeutic uses of Phentolamine Mesylate?
Phentolamine Mesylate is mainly used for hypertensive emergencies, management of pheochromocytoma, and reversing local anesthesia-induced vasoconstriction during surgical procedures.

2. Why is the market for Phentolamine Mesylate in decline?
Decline stems from safety concerns, competition from newer agents with better safety profiles, and changing clinical guidelines that limit its off-label and emergency use.

3. Are there any emerging indications for Phentolamine Mesylate?
Currently, no significant new indications are gaining traction. Most research has transitioned toward alternative vasodilators and adrenergic agents.

4. What are the key challenges faced by manufacturers of Phentolamine Mesylate?
Challenges include regulatory restrictions, decreasing demand, limited innovation, and competition from newer, more effective drugs.

5. Can Phentolamine Mesylate’s market profitability be sustained?
Sustained profitability is unlikely unless stakeholders pursue niche markets, novel formulations, or repurposing efforts to extend its clinical relevance.

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Sources
[1] "Phentolamine: Drug Profile, Uses, and Market Dynamics," Pharmaceutical Journal, 2022.
[2] "Market Analysis of Vasodilators," Global Market Insights, 2023.
[3] "Regulatory Updates on Alpha-Blockers," FDA Reports, 2022.
[4] "Innovations in Vasodilator Therapies," PharmaTech Review, 2023.