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Last Updated: January 30, 2023

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
Drug Prices for phentolamine mesylate

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Recent Clinical Trials for phentolamine mesylate

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

SponsorPhase
Cairo UniversityPhase 3
University of AlbertaN/A
University of Missouri-ColumbiaEarly Phase 1

See all phentolamine mesylate clinical trials

Pharmacology for phentolamine mesylate
Medical Subject Heading (MeSH) Categories for phentolamine mesylate

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 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

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

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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.