Cocaine hydrochloride - Generic Drug Details

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 Lxo Ireland 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. Two suppliers are listed for this compound.

Summary for cocaine hydrochloride

US Patents:	12
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	502
Patent Applications:	895
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cocaine hydrochloride
What excipients (inactive ingredients) are in cocaine hydrochloride?	cocaine hydrochloride excipients list
DailyMed Link:	cocaine hydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for cocaine hydrochloride

Constraining patent/regulatory exclusivity:

10,016,407

Dosage:

SOLUTION;NASAL

Constraining patent/regulatory exclusivity:

10,973,811

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

Sponsor	Phase
Baylor College of Medicine	PHASE1
University of Florida	EARLY_PHASE1
Brigham and Women's Hospital	PHASE1

See all cocaine hydrochloride clinical trials

Medical Subject Heading (MeSH) Categories for cocaine hydrochloride

Anesthetics, Local

Dopamine Uptake Inhibitors

Vasoconstrictor Agents

Anatomical Therapeutic Chemical (ATC) Classes for cocaine hydrochloride

N01BC	Esters of benzoic acid
N01B	ANESTHETICS, LOCAL
N01	ANESTHETICS
N	Nervous system

R02AD	Anesthetics, local
R02A	THROAT PREPARATIONS
R02	THROAT PREPARATIONS
R	Respiratory system

S01HA	Local anesthetics
S01H	LOCAL ANESTHETICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02DA	Analgesics and anesthetics
S02D	OTHER OTOLOGICALS
S02	OTOLOGICALS
S	Sensory organs

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
Omnivium Pharms	NUMBRINO	cocaine hydrochloride	SOLUTION;NASAL	209575-001	Jan 10, 2020		RX	Yes	Yes	10,149,843
Omnivium Pharms	NUMBRINO	cocaine hydrochloride	SOLUTION;NASAL	209575-001	Jan 10, 2020		RX	Yes	Yes	10,894,012
Omnivium Pharms	NUMBRINO	cocaine hydrochloride	SOLUTION;NASAL	209575-001	Jan 10, 2020		RX	Yes	Yes	10,231,961		Y
Lxo Ireland	GOPRELTO	cocaine hydrochloride	SOLUTION;NASAL	209963-001	Dec 14, 2017		RX	Yes	Yes	10,016,407
Lxo Ireland	GOPRELTO	cocaine hydrochloride	SOLUTION;NASAL	209963-001	Dec 14, 2017		RX	Yes	Yes	10,857,095

Cocaine hydrochloride Market Analysis and Financial Projection

Last updated: February 15, 2026

What Are the Market Dynamics for Cocaine Hydrochloride?

Cocaine hydrochloride is classified as a Schedule II controlled substance in the U.S., limiting its legal medical use to anesthesia for specific surgical procedures, particularly in ENT and oral surgeries. Worldwide, its medical use is restricted, with a few countries permitting limited applications under strict regulations.

Legal and Regulatory Environment: The drug remains heavily regulated globally due to its high potential for abuse and addiction. The International Narcotics Control Board (INCB) monitors its production and distribution, permitting only licensed medical and scientific use.

Production and Supply Chain: Cocaine hydrochloride is derived from coca leaves, primarily cultivated in Bolivia, Colombia, and Peru. The legal supply chain is negligible outside its approved medical applications, with illicit production worldwide exceeding legitimate usage. This illicit trade creates a black market with unpredictable supply.

Market Size and Demand: Legal procurement is confined to a limited medical segment, estimated at a few hundred kilograms annually worldwide. The illicit market, however, involves thousands of metric tons, with global street sales valued in the billions of dollars. Legal medical demand is negligible relative to illegal use.

Medical Use Trends: Few newer pharmaceuticals replace cocaine hydrochloride in anesthesia, maintaining its status as a specialized, niche product. The majority of countries have phased out its functional use, moving towards alternative anesthetics with lower abuse potential.

Research and Development: Limited R&D exists for legal applications due to its controlled status and declining medical utility. Scientific interest persists for studying its pharmacology under strict regulatory controls, but commercial investment remains minimal.

Market Drivers:

• Strict regulation limits legal market growth.
• Societal and legal risks outweigh medical benefits, constraining demand.
• Medical use persists mainly in niche surgeries, with no significant uptick forecasted.

What Is the Financial Trajectory for Cocaine Hydrochloride?

Legitimate Market Revenue: The legal market generates nominal revenue, estimated at less than $1 million annually, confined to pharmaceutical-grade cocaine for medical use in select hospitals and research institutions. The revenue growth rate remains near zero, constrained by regulatory limits.

Illicit Market Value: The global illegal cocaine market is large, with estimates exceeding 1,000 tons annually. Street sales generate approximately $150-$200 billion annually, but these figures do not translate into legitimate revenues for producers or distributors, who operate outside legal frameworks.

Investment Outlook: Pharmaceutical companies are unlikely to invest heavily in cocaine hydrochloride due to regulatory restrictions and declining medical demand. Most pharmaceutical R&D no longer focuses on this compound, limiting potential for market expansion.

Pricing Dynamics: Legal pharmaceutical cocaine maintains a high purity standard but commands minimal pricing due to scarcity and strict regulation. The illicit market price varies geographically, typically ranging from $20 to $40 per gram, driven by illegal trade dynamics rather than legitimate supply and demand.

Future Trends:

• No significant growth expected in legal use.
• Potential for increased regulation or international treaties to further restrict medical or scientific use.
• Market would rely on illicit trade, which is unpredictable, risky, and declining in some jurisdictions due to law enforcement efforts.

Key Drivers and Barriers in Market and Financial Trajectory

Factor	Impact
Regulatory Restrictions	Limit legal demand, suppress market growth
Medical Utility	Niche applications, declining due to substitutes
Illicit Trade	Large but illegal; does not contribute legally
R&D Investment	Minimal; negligible for market expansion
International Policies	Potential for tighter controls, further restricting use

Key Takeaways

• Legal medical use of cocaine hydrochloride exists in limited contexts, constrained by regulation and societal attitudes.
• The legitimate market is small, with revenue estimated below $1 million globally annually.
• The illicit cocaine market exceeds legal use in volume and value but contributes no legal revenue.
• Investment prospects are minimal due to regulatory and societal barriers.
• Market dynamics are dominated by illegal trade, with future growth unlikely in legal channels.

FAQs

1. Why is cocaine hydrochloride so heavily regulated worldwide?
Due to its high potential for abuse, addiction, and significant public health risks, authorities impose strict controls, limiting its legal medical use and criminalizing unauthorized possession and trafficking.

2. Are there any new medical applications for cocaine hydrochloride?
No significant new applications are under development. Its anesthetic properties have been largely replaced by safer, less addictive alternatives.

3. How does illicit cocaine trade impact legal markets?
Illegal trade supplies most of the global demand, with no legal revenues but considerable social costs. Legal markets are only for specialized medical use, which remain negligible.

4. Might international policy changes increase legitimate use or production?
Unlikely. Most countries are tightening drug controls, and international treaties favor restricting the substance further.

5. Can pharmaceutical investment grow in this area?
No, due to regulatory restrictions, declining medical demand, and risks associated with illicit markets, investment is improbable.

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Sources

1. United Nations Office on Drugs and Crime (UNODC), World Drug Report 2022
2. International Narcotics Control Board (INCB), Annual Reports
3. U.S. Drug Enforcement Administration (DEA), Drug Schedule and Regulations
4. Pharmaceutical industry publications and market reports
5. European Monitoring Centre for Drugs and Drug Addiction (EMCDDA)