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Phentolamine mesylate - Generic Drug Details

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What are the generic drug sources for phentolamine mesylate and what is the scope of phentolamine mesylate 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-three 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:	33
US Patents:	5
Tradenames:	3
Applicants:	4
NDAs:	4
Drug Master File Entries:	4
Suppliers / Packagers:	4
Bulk Api Vendors:	67
Clinical Trials:	530
Patent Applications:	1,170
Formulation / Manufacturing:	see details
DailyMed Link:	phentolamine mesylate at DailyMed

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

Synonyms for phentolamine mesylate

134P201

2-[N-(m-Hydroxyphenyl)-p-toluidinomethyl]imidazoline Methanesulfonate

2-[N-(m-Hydroxyphenyl)-p-toluidinomethyl]imidazoline, methanesulfonate

3-[(2-imidazolin-2-ylmethyl)(4-methylphenyl)amino]phenol, methanesulfonic acid

3-[[(4,5-Dihydro-1H-imidazol-2- yl)methyl](4-methylphenyl)-amino]phenol mesylate

3-[[(4,5-Dihydro-1H-imidazol-2-yl)methyl](4-methylphenyl)-amino]phenol mesylate

3-[4,5-dihydro-1H-imidazol-2-ylmethyl-(4-methylphenyl)amino]phenol; methanesulfonic acid

3-[N-(2-Imidazolin-2-ylmethyl)-p-toluidino]phenol methanesulphonate

3-[N-(4,5-dihydro-1H-imidazol-2-ylmethyl)-4-methyl-anilino]phenol; methanesulfonic acid

3-[N-(4,5-dihydro-1H-imidazol-2-ylmethyl)-4-methylanilino]phenol; methanesulfonic acid

3-[N-(4,5-dihydro-1H-imidazol-2-ylmethyl)-4-methylanilino]phenol;methanesulfonic acid

4CA-1013

50-60-2 (Parent)

65-28-1

A828197

A835046

AB0014005

AB2000443

AC-7472

AC1L3M27

AKOS007930193

AN-8957

AS-13800

BC200362

C17H19N3O.CH4O3S

C18H23N3O4S

CCG-222286

CCRIS 9022

CHEMBL1200873

CPD000059054

CS-2419

CTK8G2357

D00509

DR002120

DTXSID60215315

EINECS 200-604-6

EU-0100982

FT-0603267

HE375279

HMS2233A24

HMS3263E05

HMS3373D03

HMS3655B13

HY-B0362A

I14-0396

J10339

K062

KS-00000XQY

Lopac-P-7561

LP00982

LS-104726

m-(N-(2-Imidazolin-2-ylmethyl)-p-toluidino)phenol monomethanesulfonate (salt)

MCULE-3770473461

METHANESULFONIC ACID; PHENTOLAMINE

MFCD00134201

MLS000069487

MLS001076484

MolPort-003-959-154

NCGC00016195-01

NCGC00016195-02

NCGC00094282-01

NCGC00261667-01

NV-101

Opera_ID_1599

OraVerse

P 7561

P1985

Phenol, 3-(((4,5-dihydro-1H-imidazol-2-yl)methyl)(4-methylphenyl)amino)-, monomethanesulfonate (salt)

Phenol, m-(N-(2-imidazolin-2-ylmethyl)-p-toluidino)-, monomethanesulfonate (salt)

Phentolamine (mesylate)

phentolamine mesilate

Phentolamine mesilate (JAN/INN)

Phentolamine mesilate [INN:BAN]

Phentolamine mesilate for system suitability, European Pharmacopoeia (EP) Reference Standard

Phentolamine mesilate, European Pharmacopoeia (EP) Reference Standard

Phentolamine mesylate (USP)

Phentolamine mesylate [USP]

Phentolamine Mesylate, pharmaceutical secondary standard; traceable to USP, PhEur

Phentolamine mesylate, United States Pharmacopeia (USP) Reference Standard

Phentolamine methanesulfonate

Phentolamine methanesulfonate salt

Phentolamine methanesulfonate salt, >=98% (TLC), powder

Phentolamine methanesulphonate

REGID_for_CID_91430

Regitin mesylate

Regitin methanesulphonate

Regitine (TN)

Regitine mesylate

Regitine methanesulfonate

s2038

SAM002703130

SCHEMBL40852

SMR000059054

SR-01000000055

SR-01000000055-3

ST057364

Tox21_500982

UNII-Y7543E5K9T

Vasofem

Vasomax

VZ33629

W-104799

Y7543E5K9T

Z-Max

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
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
Novartis	REGITINE	phentolamine mesylate	INJECTABLE;INJECTION	008278-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No

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Non-Orange Book US Patents for phentolamine mesylate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
6,432,401	Local anesthetic methods and kits
7,261,889	Local anesthetic methods and kits

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International Patents for phentolamine mesylate

Country	Document Number	Estimated Expiration
Australia	2003247568
European Patent Office	1539170
Denmark	1280531
Australia	2005211689