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Last Updated: April 30, 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:	15
Patent Applications:	1,586
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

See drug prices for PHENTOLAMINE MESYLATE

Recent Clinical Trials for PHENTOLAMINE MESYLATE

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

Sponsor	Phase
Cairo University	Phase 3
University of Alberta	N/A
University of Missouri-Columbia	Early Phase 1

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

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
Precision Dose Inc	PHENTOLAMINE MESYLATE	phentolamine mesylate	INJECTABLE;INJECTION	207686-001	Jul 14, 2017	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Famygen Life Sci	RYZUMVI	phentolamine mesylate	SOLUTION;OPHTHALMIC	217064-001	Sep 25, 2023		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Famygen Life Sci	RYZUMVI	phentolamine mesylate	SOLUTION;OPHTHALMIC	217064-001	Sep 25, 2023		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Famygen Life Sci	RYZUMVI	phentolamine mesylate	SOLUTION;OPHTHALMIC	217064-001	Sep 25, 2023		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Famygen Life Sci	RYZUMVI	phentolamine mesylate	SOLUTION;OPHTHALMIC	217064-001	Sep 25, 2023		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hikma	PHENTOLAMINE MESYLATE	phentolamine mesylate	INJECTABLE;INJECTION	040235-001	Mar 11, 1998	AP	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a 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	⤷ Try a Trial	⤷ Try a Trial
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008	⤷ Try a Trial	⤷ Try a Trial
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008	⤷ Try a Trial	⤷ Try a Trial
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008	⤷ Try a Trial	⤷ Try a Trial
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008	⤷ Try a Trial	⤷ Try a 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
Mexico	2021004708	METODOS Y COMPOSICIONES PARA TRATAMIENTO DE PRESBICIA, MIDRIASIS Y OTROS TRASTORNOS OCULARES. (METHODS AND COMPOSITIONS FOR TREATMENT OF PRESBYOPIA, MYDRIASIS, AND OTHER OCULAR DISORDERS.)	⤷ Try a Trial
Spain	2762153		⤷ Try a Trial
Denmark	2950648		⤷ Try a Trial
Brazil	112021007725	métodos e composições para tratamento de presbiopia, midríase e outros distúrbios oculares	⤷ Try a Trial
Israel	282624	שיטות והרכבים לטיפול בזוקן ראיה, מידריאזיס והפרעות אחרות של העיניים (Methods and compositions for treatment of presbyopia, mydriasis, and other ocular disorders)	⤷ Try a Trial
Singapore	11202104094Y	METHODS AND COMPOSITIONS FOR TREATMENT OF PRESBYOPIA, MYDRIASIS, AND OTHER OCULAR DISORDERS	⤷ Try a Trial
South Korea	20210096096	노안, 산동, 및 기타 안구 장애의 치료를 위한 방법 및 조성물	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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