Last reviewed · How we verify
COCAINE HYDROCHLORIDE
Cocaine Hydrochloride is a marketed nasal anesthetic used for diagnostic procedures and surgeries, holding a niche position in the anesthetics market. Its key strength lies in its rapid onset and potent local anesthetic properties, which are critical for short-duration procedures. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generic alternatives.
At a glance
| Generic name | COCAINE HYDROCHLORIDE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2017 |
Approved indications
- Nasal Anesthesia for Diagnostic Procedures and Surgeries
Boxed warnings
- WARNING: ABUSE AND DEPENDENCE CNS stimulants, including cocaine hydrochloride, have a high potential for abuse and dependence [see Warning and Precautions (5.1) . ] WARNING: ABUSE AND DEPENDENCE See full prescribing information for complete boxed warning. CNS stimulants, including cocaine hydrochloride, have a high potential for abuse and dependence. (5.1)
Common side effects
- Hypertension
- Hypertension
- Tachycardia
- Tachycardia
- Sinus tachycardia
- Sinus tachycardia
- Bradycardia
- Nausea
- Anxiety
Serious adverse events
- Myocardial ischemia and infarction
- Atrial and ventricular arrhythmias
- Paroxysmal tachycardia
- Vasovagal syncope with bradycardia
- Seizure
- Diastolic hypertension
Drug interactions
- Disulfiram
- Epinephrine, Phenylephrine
- Inhibitors of plasma cholinesterase (pseudocholinesterase)
Key clinical trials
- AAV8-hCocH for Cocaine Use Disorder (PHASE1)
- Harm Reduction Services (NA)
- Repurposing Semaglutide for the Treatment of Cocaine Use Disorder (PHASE2)
- Efficacy and Safety of Sustained-release Dexamphetamine in Patients With Moderate to Severe Cocaine Use Disorder (PHASE2)
- Exenatide For Reducing the Reinforcing Effects of Cocaine (PHASE1)
- Stimulant and Polysubstance Use, Inflammation, and Sex Effects on Myocardial Disease in HIV
- Reconsolidation Blockade of Intrusive Trauma- and Cocaine-related Memories (NA)
- Transcranial Direct Current Stimulation (tDCS) for Treatment of Cocaine Use Disorder (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- COCAINE HYDROCHLORIDE CI brief — competitive landscape report
- COCAINE HYDROCHLORIDE updates RSS · CI watch RSS