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Last Updated: February 26, 2024

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 four branded drugs marketed by Septodont Holding, Hikma, Precision Dose Inc, Novartis, and Ocuphire, and is included in five 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
Hikma PHENTOLAMINE MESYLATE phentolamine mesylate INJECTABLE;INJECTION 040235-001 Mar 11, 1998 AP RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Septodont Holding ORAVERSE phentolamine mesylate INJECTABLE;INJECTION 022159-001 May 9, 2008 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis REGITINE phentolamine mesylate INJECTABLE;INJECTION 008278-003 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Septodont Holding ORAVERSE phentolamine mesylate INJECTABLE;INJECTION 022159-001 May 9, 2008 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Septodont Holding ORAVERSE phentolamine mesylate INJECTABLE;INJECTION 022159-001 May 9, 2008 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Ocuphire RYZUMVI phentolamine mesylate SOLUTION;OPHTHALMIC 217064-001 Sep 25, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 ⤷  Try a Trial ⤷  Try a Trial
Septodont Holding ORAVERSE phentolamine mesylate INJECTABLE;INJECTION 022159-001 May 9, 2008 ⤷  Try a Trial ⤷  Try a Trial
Septodont Holding ORAVERSE phentolamine mesylate INJECTABLE;INJECTION 022159-001 May 9, 2008 ⤷  Try a Trial ⤷  Try a Trial
Septodont Holding ORAVERSE phentolamine mesylate INJECTABLE;INJECTION 022159-001 May 9, 2008 ⤷  Try a Trial ⤷  Try a Trial
Septodont Holding ORAVERSE phentolamine mesylate INJECTABLE;INJECTION 022159-001 May 9, 2008 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for phentolamine mesylate

Country Patent Number Title Estimated Expiration
Brazil PI0311965 formulação líquida estável e seu uso para aumentar fluxo sanguíneo em mamífero, método de preparação de forma de dosagem única de formulação líquida estável, bem como recipiente e kit ⤷  Try a Trial
Norway 20050300 ⤷  Try a Trial
Hong Kong 1079444 穩定的阿爾法腎上腺素能受體拮抗藥製劑及其用途 (STABILIZED FORMULATIONS OF ALPHA ADRENERGIC RECEPTOR ANTAGONISTS AND USES THEREOF) ⤷  Try a Trial
Japan 2010280702 STABILIZED FORMULATION OF ALPHA ADRENERGIC RECEPTOR ANTAGONISTS AND USE THEREOF ⤷  Try a Trial
Japan 4787977 ⤷  Try a Trial
Australia 2003247568 STABILIZED FORMULATIONS OF ALPHA ADRENERGIC RECEPTOR ANTAGONISTS AND USES THEREOF ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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