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, Hikma, Precision Dose Inc, and Novartis, and is included in four NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Phentolamine mesylate has sixteen patent family members in twelve countries.

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

Summary for phentolamine mesylate

International Patents:	16
US Patents:	3
Tradenames:	3
Applicants:	4
NDAs:	4
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	106
Clinical Trials:	15
Patent Applications:	1,566
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
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Hikma	PHENTOLAMINE MESYLATE	phentolamine mesylate	INJECTABLE;INJECTION	040235-001	Mar 11, 1998	AP	RX	No	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Precision Dose Inc	PHENTOLAMINE MESYLATE	phentolamine mesylate	INJECTABLE;INJECTION	207686-001	Jul 14, 2017	AP	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Novartis	REGITINE	phentolamine mesylate	INJECTABLE;INJECTION	008278-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
>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	See Plans and Pricing	See Plans and Pricing
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008	See Plans and Pricing	See Plans and Pricing
>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	PA04012507	FORMULACIONES ESTABILIZADAS PARA ANTOAGONISTAS DEL RECEPTOR ALFA-ADRENERGICO Y USOS DE LAS MISMAS. (STABILIZED FORMULATIONS OF ALPHA ADRENERGIC RECEPTOR ANTAGONISTS AND USES THEREOF.)	See Plans and Pricing
Israel	165599	תכשירים נוזליים יציבים המכילים אנטגוניסט לקולטן אלפא אדרנרגי במינון נמוך ושימושים בהם (Stable liquid compositions comprising a low dose alpha adrenergic receptor antagonist and uses thereof)	See Plans and Pricing
Brazil	0311965	Formulações estabilizadas de antagonistas de receptores alfa adrenérgicos e os seus usos	See Plans and Pricing
Japan	2005533869		See Plans and Pricing
Japan	2010280702	STABILIZED FORMULATION OF ALPHA ADRENERGIC RECEPTOR ANTAGONISTS AND USE THEREOF	See Plans and Pricing
Australia	2003247568	STABILIZED FORMULATIONS OF ALPHA ADRENERGIC RECEPTOR ANTAGONISTS AND USES THEREOF	See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

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