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Phentolamine mesylate - Generic Drug Details

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:	72
Clinical Trials:	7
Patent Applications:	1,195
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

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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
Novartis	REGITINE	phentolamine mesylate	INJECTABLE;INJECTION	008278-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008		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	Y			➤ Sign Up
Precision Dose Inc	PHENTOLAMINE MESYLATE	phentolamine mesylate	INJECTABLE;INJECTION	207686-001	Jul 14, 2017	AP	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008		RX	Yes	Yes	➤ Sign Up	➤ Sign Up				➤ Sign Up
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008		RX	Yes	Yes	➤ Sign Up	➤ Sign Up				➤ Sign Up
West-ward Pharms Int	PHENTOLAMINE MESYLATE	phentolamine mesylate	INJECTABLE;INJECTION	040235-001	Mar 11, 1998	AP	RX	No	Yes	➤ Sign Up	➤ Sign Up				➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration

International Patents for phentolamine mesylate

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Country	Document Number	Estimated Expiration
Mexico	PA04012507	➤ Sign Up
China	100391460	➤ Sign Up
Japan	2003532678	➤ Sign Up
World Intellectual Property Organization (WIPO)	0185171	➤ Sign Up
Japan	4787977	➤ Sign Up
Denmark	1280531	➤ Sign Up
Australia	2003247568	➤ Sign Up
Country	Document Number	Estimated Expiration