Last Updated: September 24, 2026

PHENTOLAMINE MESYLATE - Generic Drug Details

Name: PHENTOLAMINE MESYLATE Generic Launch, Drug Patent, and Exclusivity Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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What are the generic drug sources for phentolamine mesylate and what is the scope of freedom to operate?

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 eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Four suppliers are listed for this compound.

Summary for PHENTOLAMINE MESYLATE

International Patents:	39
US Patents:	11
Tradenames:	4
Applicants:	5
NDAs:	5
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	88
Clinical Trials:	16
Patent Applications:	1,860
Drug Prices:	Drug price trends for PHENTOLAMINE MESYLATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Famygen Life Sci	RYZUMVI	phentolamine mesylate	SOLUTION;OPHTHALMIC	217064-001	Sep 25, 2023		RX	Yes	Yes	12,350,366	⤷ Start Trial	Y			⤷ Start Trial
Famygen Life Sci	RYZUMVI	phentolamine mesylate	SOLUTION;OPHTHALMIC	217064-001	Sep 25, 2023		RX	Yes	Yes	12,576,067	⤷ Start Trial				⤷ Start Trial
Famygen Life Sci	RYZUMVI	phentolamine mesylate	SOLUTION;OPHTHALMIC	217064-001	Sep 25, 2023		RX	Yes	Yes	10,278,918	⤷ Start Trial	Y			⤷ Start Trial
Hikma	PHENTOLAMINE MESYLATE	phentolamine mesylate	INJECTABLE;INJECTION	040235-001	Mar 11, 1998	AP	RX	No	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Novartis	REGITINE	phentolamine mesylate	INJECTABLE;INJECTION	008278-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for PHENTOLAMINE MESYLATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008	6,764,678	⤷ Start Trial
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008	7,569,230	⤷ Start Trial
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008	7,229,630	⤷ Start Trial
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008	7,575,757	⤷ Start Trial
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008	6,872,390	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for PHENTOLAMINE MESYLATE

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Country	Patent Number	Title	Estimated Expiration
Australia	2014212274	Aqueous ophthalmic solutions of phentolamine and medical uses thereof	⤷ Start Trial
Australia	2018200566	AQUEOUS OPHTHALMIC SOLUTIONS OF PHENTOLAMINE AND MEDICAL USES THEREOF	⤷ Start Trial
Canada	2899339	SOLUTIONS OPHTALMIQUES AQUEUSES DE PHENTOLAMINE ET UTILISATIONS MEDICALES ASSOCIEES (AQUEOUS OPHTHALMIC SOLUTIONS OF PHENTOLAMINE AND MEDICAL USES THEREOF)	⤷ Start Trial
Denmark	2950648		⤷ Start Trial
European Patent Office	2950648	SOLUTIONS OPHTALMIQUES AQUEUSES DE PHENTOLAMINE ET UTILISATIONS MÉDICALES ASSOCIÉES (AQUEOUS OPHTHALMIC SOLUTIONS OF PHENTOLAMINE AND MEDICAL USES THEREOF)	⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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