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Phentolamine mesylate - Generic Drug Details

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

Phentolamine mesylate is the generic ingredient in three branded drugs marketed by Septodont Holding, Precision Dose Inc, West-ward Pharms Int, and Novartis, and is included in four NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Phentolamine mesylate has thirty-four patent family members in twenty countries.

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

Summary for phentolamine mesylate

International Patents:	34
US Patents:	5
Tradenames:	3
Applicants:	4
NDAs:	4
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	99
Clinical Trials:	11
Patent Applications:	1,371
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
University of Missouri-Columbia	Early Phase 1
Ocuphire Pharma, Inc.	Phase 2
University of Cambridge	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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	REGITINE	phentolamine mesylate	INJECTABLE;INJECTION	008278-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008		RX	Yes	Yes
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008		RX	Yes	Yes			Y
West-ward Pharms Int	PHENTOLAMINE MESYLATE	phentolamine mesylate	INJECTABLE;INJECTION	040235-001	Mar 11, 1998	AP	RX	No	Yes
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008		RX	Yes	Yes			Y

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

International Patents for phentolamine mesylate

Country	Patent Number	Estimated Expiration
European Patent Office	1539170
Brazil	PI0311965
Cyprus	1107617
Japan	2003532678
Germany	60126265