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Last Updated: November 24, 2020

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Cocaine hydrochloride - Generic Drug Details

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

Cocaine hydrochloride is the generic ingredient in two branded drugs marketed by Genus Lifesciences and Cody Labs Inc, and is included in two NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for cocaine hydrochloride. Two suppliers are listed for this compound.

Recent Clinical Trials for cocaine hydrochloride

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

SponsorPhase
University of KentuckyEarly Phase 1
Embera NeuroTherapeutics, Inc.Phase 2
Beth Israel Deaconess Medical CenterPhase 1

See all cocaine hydrochloride clinical trials

Medical Subject Heading (MeSH) Categories for cocaine hydrochloride

US Patents and Regulatory Information for cocaine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Genus Lifesciences GOPRELTO cocaine hydrochloride SOLUTION;NASAL 209963-001 Dec 14, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Cody Labs Inc NUMBRINO cocaine hydrochloride SOLUTION;NASAL 209575-001 Jan 10, 2020 RX No No   Start Trial   Start Trial   Start Trial
Genus Lifesciences GOPRELTO cocaine hydrochloride SOLUTION;NASAL 209963-001 Dec 14, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Genus Lifesciences GOPRELTO cocaine hydrochloride SOLUTION;NASAL 209963-001 Dec 14, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Genus Lifesciences GOPRELTO cocaine hydrochloride SOLUTION;NASAL 209963-001 Dec 14, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Genus Lifesciences GOPRELTO cocaine hydrochloride SOLUTION;NASAL 209963-001 Dec 14, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Genus Lifesciences GOPRELTO cocaine hydrochloride SOLUTION;NASAL 209963-001 Dec 14, 2017 RX Yes Yes   Start Trial   Start Trial Y   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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