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Last Updated: July 16, 2024

PHENTOLAMINE MESYLATE - Generic Drug Details

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

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

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

Summary for PHENTOLAMINE MESYLATE

International Patents:	23
US Patents:	6
Tradenames:	4
Applicants:	5
NDAs:	5
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	110
Clinical Trials:	16
Patent Applications:	1,555
Formulation / Manufacturing:	see details
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

Drug Prices for PHENTOLAMINE MESYLATE

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

US Patents and Regulatory Information for PHENTOLAMINE MESYLATE

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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
Hikma	PHENTOLAMINE MESYLATE	phentolamine mesylate	INJECTABLE;INJECTION	040235-001	Mar 11, 1998	AP	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Famygen Life Sci	RYZUMVI	phentolamine mesylate	SOLUTION;OPHTHALMIC	217064-001	Sep 25, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Famygen Life Sci	RYZUMVI	phentolamine mesylate	SOLUTION;OPHTHALMIC	217064-001	Sep 25, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Famygen Life Sci	RYZUMVI	phentolamine mesylate	SOLUTION;OPHTHALMIC	217064-001	Sep 25, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Famygen Life Sci	RYZUMVI	phentolamine mesylate	SOLUTION;OPHTHALMIC	217064-001	Sep 25, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Famygen Life Sci	RYZUMVI	phentolamine mesylate	SOLUTION;OPHTHALMIC	217064-001	Sep 25, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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	⤷ Sign Up	⤷ Sign Up
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008	⤷ Sign Up	⤷ Sign Up
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008	⤷ Sign Up	⤷ Sign Up
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008	⤷ Sign Up	⤷ Sign Up
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008	⤷ Sign Up	⤷ Sign Up
>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
Israel	282624		⤷ Sign Up
Australia	2018200566	AQUEOUS OPHTHALMIC SOLUTIONS OF PHENTOLAMINE AND MEDICAL USES THEREOF	⤷ Sign Up
China	113164452		⤷ Sign Up
Spain	2762153		⤷ Sign Up
Brazil	112021007725		⤷ Sign Up
Denmark	2950648		⤷ Sign Up
Canada	2899339	SOLUTIONS OPHTALMIQUES AQUEUSES DE PHENTOLAMINE ET UTILISATIONS MEDICALES ASSOCIEES (AQUEOUS OPHTHALMIC SOLUTIONS OF PHENTOLAMINE AND MEDICAL USES THEREOF)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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