METHAMPHETAMINE HYDROCHLORIDE - Generic Drug Details

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

Methamphetamine hydrochloride is the generic ingredient in three branded drugs marketed by Ajenat Pharms, Teva, Able, Dr Reddys Labs Sa, Hikma, and Rexar, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for methamphetamine hydrochloride. Two suppliers are listed for this compound.

Summary for METHAMPHETAMINE HYDROCHLORIDE

US Patents:	0
Tradenames:	3
Applicants:	6
NDAs:	7
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	141
Patent Applications:	2,840
What excipients (inactive ingredients) are in METHAMPHETAMINE HYDROCHLORIDE?	METHAMPHETAMINE HYDROCHLORIDE excipients list
DailyMed Link:	METHAMPHETAMINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for METHAMPHETAMINE HYDROCHLORIDE

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

Sponsor	Phase
University of Florida	Early Phase 1
Carolyn Rodriguez	Phase 2
Centre hospitalier de l'Université de Montréal (CHUM)	Phase 2

See all METHAMPHETAMINE HYDROCHLORIDE clinical trials

Pharmacology for METHAMPHETAMINE HYDROCHLORIDE

Drug Class	Amphetamine Anorectic Central Nervous System Stimulant
Physiological Effect	Appetite Suppression Central Nervous System Stimulation Increased Sympathetic Activity

Medical Subject Heading (MeSH) Categories for METHAMPHETAMINE HYDROCHLORIDE

Adrenergic Agents

Adrenergic Uptake Inhibitors

Central Nervous System Stimulants

Dopamine Agents

Dopamine Uptake Inhibitors

Sympathomimetics

US Patents and Regulatory Information for METHAMPHETAMINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Able	METHAMPHETAMINE HYDROCHLORIDE	methamphetamine hydrochloride	TABLET;ORAL	040529-001	Feb 25, 2004		DISCN	No	No
Ajenat Pharms	DESOXYN	methamphetamine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	005378-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Ajenat Pharms	DESOXYN	methamphetamine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	005378-005	Approved Prior to Jan 1, 1982		DISCN	No	No
Rexar	METHAMPHETAMINE HYDROCHLORIDE	methamphetamine hydrochloride	TABLET;ORAL	084931-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Ajenat Pharms	DESOXYN	methamphetamine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	005378-004	Approved Prior to Jan 1, 1982		DISCN	No	No
Teva	METHAMPEX	methamphetamine hydrochloride	TABLET;ORAL	083889-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Dr Reddys Labs Sa	METHAMPHETAMINE HYDROCHLORIDE	methamphetamine hydrochloride	TABLET;ORAL	091189-001	Apr 21, 2010	AA	RX	No	No

METHAMPHETAMINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Methamphetamine Hydrochloride

Global Context of Methamphetamine

Methamphetamine is the most widely consumed synthetic stimulant drug globally, with a significant presence in various regions, including Asia, North America, and Australia. Despite its global reach, Europe remains a relatively small market compared to these regions[3].

Production and Trafficking

Global Production Hubs

Methamphetamine production is concentrated in several key regions:

• Mexico: Known for large-scale industrial production, Mexican Transnational Criminal Organizations (TCOs) produce highly pure methamphetamine, which is then exported globally, including to the United States[5].
• Myanmar and the Lower Mekong Basin: This region is a significant hub for methamphetamine production, catering to consumers in Asia and Oceania[3].
• Europe: Countries like the Netherlands, Belgium, and Czechia are emerging as important production sites. There is notable collaboration between European and Mexican producers, enhancing production capacity and sophistication[1].

Collaboration and Expertise

The collaboration between European and Mexican producers has driven the development of more sophisticated and large-scale production facilities in Europe. This partnership leverages existing infrastructure in Europe for producing synthetic drugs, making methamphetamine production more efficient and profitable[1].

Market Expansion and Trends

Increasing Seizures and Production

Global seizures of methamphetamine have been increasing, with a significant rise over the past five years. In 2019, 325 tonnes of methamphetamine were seized globally, more than 70% of all amphetamines seized. This trend indicates a growing market and increased production capacity[3].

Europe's Emerging Role

In Europe, the quantity of methamphetamine seized increased by 477% from 2010 to 2020, highlighting the expanding market. Large-scale production facilities in the Netherlands and Belgium have been dismantled, but new ones continue to emerge, reflecting the evolving nature of the market[1].

Prices and Purities

Retail Prices

Retail prices of methamphetamine vary significantly across Europe, ranging from €13.50 per gram in Hungary to €113 per gram in Cyprus. The type of methamphetamine, with powder generally being cheaper than crystal methamphetamine, influences these prices. Darknet data suggests an average price of €55 per gram[1].

Wholesale Prices

Wholesale prices have seen a notable decrease. In Czechia, the wholesale price for locally produced methamphetamine ranges between €18,900 and €21,200 per kilogram. In the Netherlands, the wholesale price dropped by almost 40% from €12,750 in 2019 to €7,675 per kilogram in 2020[1].

Economic Costs and Impacts

Global Economic Burden

The economic cost of methamphetamine use is substantial. In the United States, for example, the estimated economic cost of methamphetamine use in 2005 was between $16.2 billion and $48.3 billion. This includes costs related to addiction, premature death, drug treatment, lost productivity, crime, and health care[2].

Specific Costs

• Addiction and Premature Death: These intangible burdens account for nearly two-thirds of the economic costs.
• Crime and Criminal Justice: Significant costs are associated with crime and the criminal justice system.
• Lost Productivity: The economic impact of lost productivity due to methamphetamine use is considerable.
• Health Care: Health care costs, including treatment for methamphetamine use disorder and related health issues, are also substantial[2].

Trafficking and Distribution

Methamphetamine Trafficking Offenses

In the United States, methamphetamine offenses have become the predominant drug trafficking offense, accounting for approximately half of all drug trafficking offenses sentenced federally in 2022. Mexican TCOs control most of the wholesale and retail distribution of methamphetamine in the U.S.[5].

Conversion Laboratories

In addition to production laboratories, conversion laboratories play a crucial role in the trafficking process. These labs convert powder methamphetamine into crystal form, enrich its purity, or mix it with other substances, making it more marketable[5].

Financial Trajectory

Profitability

The profitability of methamphetamine production and trafficking is high due to its demand and the efficiency of large-scale production. The collaboration between European and Mexican producers has enhanced profitability by leveraging existing infrastructure and expertise[1].

Market Fluctuations

The financial trajectory of the methamphetamine market is influenced by various factors, including changes in precursor chemical availability, law enforcement efforts, and shifts in global demand. Despite these fluctuations, the market has shown resilience and adaptability, with producers finding ways to bypass regulations and maintain production levels[1][5].

Regional Market Dynamics

Asia and Oceania

In these regions, methamphetamine use is significant, with more than a quarter of people in drug treatment being treated for amphetamine-type stimulant use disorder. The production in Myanmar and other parts of the Lower Mekong Basin caters to this demand[3].

North America

The North American market, particularly the United States, is served by large-scale industrial production in Mexico. The purity and potency of methamphetamine in this region remain high, while prices are relatively low, contributing to its widespread use[3].

Europe

Europe's role in the methamphetamine market is evolving, with increasing production and trafficking activities. The collaboration with Mexican producers and the establishment of industrial-scale laboratories in the Netherlands and Belgium highlight Europe's growing importance in the global methamphetamine market[1].

Key Takeaways

• Global Reach: Methamphetamine is the most widely consumed synthetic stimulant drug globally.
• Production Hubs: Key production hubs include Mexico, Myanmar, and Europe.
• Collaboration: European and Mexican producers collaborate to enhance production capacity and sophistication.
• Economic Costs: The economic burden of methamphetamine use is significant, affecting health care, crime, and productivity.
• Market Dynamics: The market is influenced by changes in precursor chemical availability, law enforcement, and global demand.
• Financial Trajectory: The profitability of methamphetamine production and trafficking remains high despite market fluctuations.

FAQs

What are the main production hubs for methamphetamine globally?

The main production hubs for methamphetamine include Mexico, Myanmar and the Lower Mekong Basin, and Europe, particularly the Netherlands, Belgium, and Czechia[1][3].

How has the collaboration between European and Mexican producers impacted the methamphetamine market?

The collaboration has driven the development of more sophisticated and large-scale production facilities in Europe, leveraging existing infrastructure and expertise to increase production capacity and profitability[1].

What are the economic costs associated with methamphetamine use?

The economic costs include the burden of addiction, premature death, drug treatment, lost productivity, crime, and health care, with estimated costs in the United States ranging from $16.2 billion to $48.3 billion in 2005[2].

How has the retail price of methamphetamine varied across Europe?

Retail prices vary significantly, ranging from €13.50 per gram in Hungary to €113 per gram in Cyprus, with the type of methamphetamine influencing these prices[1].

What role do conversion laboratories play in the methamphetamine trafficking process?

Conversion laboratories convert powder methamphetamine into crystal form, enrich its purity, or mix it with other substances, making it more marketable and ready for retail distribution[5].

References

1. EU Drug Market: Methamphetamine. European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) and Europol, 2022.
2. The Economic Cost of Methamphetamine Use in the United States, 2005. RAND Corporation, 2009.
3. The methamphetamine market: global context. European Monitoring Centre for Drugs and Drug Addiction (EMCDDA), 2022.
4. Wisconsin Methamphetamine Study. Wisconsin Department of Justice, 2016.
5. Methamphetamine Trafficking Offenses in the Federal Criminal Justice System. United States Sentencing Commission, 2024.