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Last Updated: April 22, 2024

Cocaine hydrochloride - Generic Drug Details


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What are the generic drug 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 Noden Pharma and Omnivium Pharms, and is included in two NDAs. There are twelve 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. Four suppliers are listed for this compound.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for cocaine hydrochloride
Generic Entry Dates for cocaine hydrochloride*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;NASAL
Generic Entry Dates for cocaine hydrochloride*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;NASAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for cocaine hydrochloride

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

SponsorPhase
The Netherlands Cancer InstitutePhase 2
Het Zwarte GatPhase 2
Radboud University Medical CenterPhase 2

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
Noden Pharma GOPRELTO cocaine hydrochloride SOLUTION;NASAL 209963-001 Dec 14, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Noden Pharma GOPRELTO cocaine hydrochloride SOLUTION;NASAL 209963-001 Dec 14, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Omnivium Pharms NUMBRINO cocaine hydrochloride SOLUTION;NASAL 209575-001 Jan 10, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Noden Pharma GOPRELTO cocaine hydrochloride SOLUTION;NASAL 209963-001 Dec 14, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Noden Pharma GOPRELTO cocaine hydrochloride SOLUTION;NASAL 209963-001 Dec 14, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Noden Pharma GOPRELTO cocaine hydrochloride SOLUTION;NASAL 209963-001 Dec 14, 2017 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

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