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Last Updated: October 7, 2024

REGITINE Drug Patent Profile


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When do Regitine patents expire, and when can generic versions of Regitine launch?

Regitine is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in REGITINE is phentolamine mesylate. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the phentolamine mesylate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Regitine

A generic version of REGITINE was approved as phentolamine mesylate by HIKMA on March 11th, 1998.

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Summary for REGITINE
Drug patent expirations by year for REGITINE
Recent Clinical Trials for REGITINE

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

SponsorPhase
National Institutes of Health (NIH)Early Phase 1
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Early Phase 1
University of PennsylvaniaEarly Phase 1

See all REGITINE clinical trials

US Patents and Regulatory Information for REGITINE

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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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