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Last Updated: August 7, 2020

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Prilocaine hydrochloride - Generic Drug Details

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

Prilocaine hydrochloride is the generic ingredient in four branded drugs marketed by Astrazeneca, Dentsply Pharm, and Septodont Inc, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for prilocaine hydrochloride. One supplier is listed for this compound.

Summary for prilocaine hydrochloride
Recent Clinical Trials for prilocaine hydrochloride

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

SponsorPhase
Stanford UniversityPhase 3
Tehran University of Medical SciencesPhase 3
Guy's and St Thomas' NHS Foundation TrustPhase 4

See all prilocaine hydrochloride clinical trials

Pharmacology for prilocaine hydrochloride
Drug ClassAmide Local Anesthetic
Physiological EffectLocal Anesthesia
Medical Subject Heading (MeSH) Categories for prilocaine hydrochloride

US Patents and Regulatory Information for prilocaine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dentsply Pharm CITANEST PLAIN DENTAL prilocaine hydrochloride INJECTABLE;INJECTION 021382-001 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Astrazeneca CITANEST PLAIN prilocaine hydrochloride INJECTABLE;INJECTION 014763-007 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Astrazeneca CITANEST prilocaine hydrochloride INJECTABLE;INJECTION 014763-005 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Astrazeneca CITANEST prilocaine hydrochloride INJECTABLE;INJECTION 014763-003 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Septodont Inc PRILOCAINE HYDROCHLORIDE prilocaine hydrochloride INJECTABLE;INJECTION 079235-001 Sep 29, 2010 RX No Yes   Start Trial   Start Trial   Start Trial
>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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