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Last Updated: November 4, 2024

PHENTOLAMINE MESYLATE - Generic Drug Details


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What are the generic drug sources for phentolamine mesylate and what is the scope of freedom to operate?

Phentolamine mesylate is the generic ingredient in four branded drugs marketed by Septodont Holding, Hikma, Precision Dose Inc, Novartis, and Famygen Life Sci, and is included in five NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Phentolamine mesylate has twenty-three patent family members in sixteen countries.

There are three drug master file entries for phentolamine mesylate. Five 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
University of AlbertaPhase 4
Cairo UniversityPhase 3
University of AlbertaN/A

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
Famygen Life Sci RYZUMVI phentolamine mesylate SOLUTION;OPHTHALMIC 217064-001 Sep 25, 2023 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 ⤷  Sign Up
Famygen Life Sci RYZUMVI phentolamine mesylate SOLUTION;OPHTHALMIC 217064-001 Sep 25, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Famygen Life Sci RYZUMVI phentolamine mesylate SOLUTION;OPHTHALMIC 217064-001 Sep 25, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis REGITINE phentolamine mesylate INJECTABLE;INJECTION 008278-003 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Famygen Life Sci RYZUMVI phentolamine mesylate SOLUTION;OPHTHALMIC 217064-001 Sep 25, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Septodont Holding ORAVERSE phentolamine mesylate INJECTABLE;INJECTION 022159-001 May 9, 2008 ⤷  Sign Up ⤷  Sign Up
Septodont Holding ORAVERSE phentolamine mesylate INJECTABLE;INJECTION 022159-001 May 9, 2008 ⤷  Sign Up ⤷  Sign Up
Septodont Holding ORAVERSE phentolamine mesylate INJECTABLE;INJECTION 022159-001 May 9, 2008 ⤷  Sign Up ⤷  Sign Up
Septodont Holding ORAVERSE phentolamine mesylate INJECTABLE;INJECTION 022159-001 May 9, 2008 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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