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Last Updated: November 14, 2019

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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 one branded drug marketed by Genus Lifesciences and is included in one NDA. There are four 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. One supplier is listed for this compound.

Recent Clinical Trials for cocaine hydrochloride

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

SponsorPhase
William StoopsEarly Phase 1
US Department of Veterans AffairsEarly Phase 1
Public Health Management CorporationPhase 4

See all cocaine hydrochloride clinical trials

Medical Subject Heading (MeSH) Categories for cocaine hydrochloride
Synonyms for cocaine hydrochloride
(-)-Cocaine hydrochloride
(1R,2R,3S,5S)-3-(Benzoyloxy)-8-methyl-8-azabicyclo[3.2.1]octane-2-carboxylic Acid Methyl Ester Hydrochloride
1-alpha-H,5-alpha-H-Tropane-2-beta-carboxylic acid, 3-beta-hydroxy-, methyl ester, benzoate (ester), hydrochloride
1alpha-H,5alpha-H-Tropane-2beta-carboxylic acid, 3beta-hydroxy-,
1alphaH,5alphaH-Tropane-2beta-carboxylic acid, 3beta-hydroxy-, methyl ester, benzoate (ester), hydrochloride (8CI)
3?-Hydroxy-1?H,5?H-tropane-2?-carboxylic acid methyl ester benzoate hydrochloride
50-36-2 (Parent)
53-21-4
8-Azabicyclo(3.2.1)octane-2-carboxylic acid, 3-(benzoyloxy)-8-methyl-, methyl ester, hydrochloride, (1R-(exo,exo))-
AC1LCVLE
AKOS024457309
B5340
CAS-53-21-4
CC-25956
CHEBI:613010
CHEMBL529437
Cocain-chlorhydrat
Cocain-chlorhydrat [German]
Cocaine chloride
Cocaine HCl
Cocaine hydrochloride [USP:JAN]
Cocaine hydrochloride solution
Cocaine hydrochloride solution, ~1 mg/mL in methanol, analytical standard, for drug analysis
Cocaine hydrochloride solution, 1.0 mg/mL in methanol, analytical standard, for drug analysis
Cocaine hydrochloride, analytical standard
Cocaine hydrochloride, United States Pharmacopeia (USP) Reference Standard
Cocaine muriate
DSSTox_CID_28829
DSSTox_GSID_48903
DSSTox_RID_83098
DTXSID2048903
Ecgonine methyl ester benzoate hydrochloride
EINECS 200-167-1
l-Cocaine hydrochloride
methyl (1S,3S,4R,5R)-3-benzoyloxy-8-methyl-8-azabicyclo[3.2.1]octane-4-carboxylate hydrochloride
methyl (1S,3S,4R,5R)-3-benzoyloxy-8-methyl-8-azabicyclo[3.2.1]octane-4-carboxylate;hydrochloride
Methyl 3-beta-hydroxy-1-alpha-H,5-alpha-H-tropan-2-beta-carboxylate, benzoate (ester) HCl
Methyl 3beta-hydroxy-1alphaH,5alphaH-tropan-2beta-carboxylate, benzoate (ester) hydrochloride
NCGC00159467-03
NSC 25263
PIQVDUKEQYOJNR-VZXSFKIWSA-N
Sal de merck
SCHEMBL186755
Tox21_112883
UNII-XH8T8T6WZH
XH8T8T6WZH

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
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
>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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