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Last Updated: January 29, 2026

METHAMPHETAMINE HYDROCHLORIDE - Generic Drug Details


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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. Three 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: 3
Raw Ingredient (Bulk) Api Vendors: 33
Clinical Trials: 157
Patent Applications: 6,560
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

SponsorPhase
University of FloridaEARLY_PHASE1
U.S. Department of JusticePHASE1
University of Wisconsin, MadisonPHASE1

See all METHAMPHETAMINE HYDROCHLORIDE clinical trials

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
Dr Reddys Labs Sa METHAMPHETAMINE HYDROCHLORIDE methamphetamine hydrochloride TABLET;ORAL 091189-001 Apr 21, 2010 AA RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Ajenat Pharms DESOXYN methamphetamine hydrochloride TABLET, EXTENDED RELEASE;ORAL 005378-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Teva METHAMPEX methamphetamine hydrochloride TABLET;ORAL 083889-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Teva METHAMPHETAMINE HYDROCHLORIDE methamphetamine hydrochloride TABLET;ORAL 086359-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Hikma METHAMPHETAMINE HYDROCHLORIDE methamphetamine hydrochloride TABLET;ORAL 203846-001 Nov 17, 2015 AA RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Able METHAMPHETAMINE HYDROCHLORIDE methamphetamine hydrochloride TABLET;ORAL 040529-001 Feb 25, 2004 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Ajenat Pharms DESOXYN methamphetamine hydrochloride TABLET, EXTENDED RELEASE;ORAL 005378-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Methamphetamine Hydrochloride

Last updated: January 1, 2026

Executive Summary

Methamphetamine hydrochloride, a potent central nervous system stimulant, remains a contentious compound with significant implications across pharmaceutical, regulatory, illicit markets, and law enforcement sectors. While its medical applications are limited and heavily controlled, the drug’s underground market and societal impacts significantly influence its demand, supply, and associated economic activities. This report examines the current market landscape, significant drivers shaping its trajectory, financial implications, regulatory environment, and future outlook.


What Are the Pharmacological and Medical Aspects of Methamphetamine Hydrochloride?

Medical Use and Regulatory Status

Methamphetamine hydrochloride is classified as a Schedule II controlled substance under the Controlled Substances Act (CSA) in the US, restricted to certain medical indications such as ADHD and short-term weight management under strict regulations ([2]). Its medical formulations include Desoxyn, approved by the FDA in 1943, primarily for treatment-resistant ADHD ([3]).

Pharmacodynamics and Efficacy

Methamphetamine acts by increasing synaptic concentrations of dopamine, norepinephrine, and serotonin, making it highly reinforcing and addictive ([4]). The drug's pharmacokinetics involve rapid absorption with a half-life of approximately 12 hours, contributing to its high abuse potential.


What Are the Key Market Drivers and Restraints?

Drivers Impact Restraints Impact
Medical Demand (Limited) Niche market with stable demand; especially in treatment-resistant cases Regulatory restrictions Limits authorized medical use and accessibility
Illicit Market Dynamics Largest driver of economic activity around methamphetamine; estimated global value in illicit markets exceeds $50 billion ([5]) Law enforcement crackdowns and international treaties Disrupt production and trafficking routes
Production Technologies Emergence of clandestine labs; increased supply flexibility Detection and interdiction efforts Reduce illegal supply over time
Socioeconomic Factors Addiction epidemiology influences demand; regions with high unemployment see increased illicit use ([6]) Social stigma and treatment barriers Limit scope of medical and harm reduction programs

How Has the Market Evolved Over Recent Years?

Historical Context

Historically, methamphetamine emerged as a therapeutic agent in the early 20th century, with widespread medical and military use during World War II ([7]). Post-1960s, recreational use surged, leading to an increased focus on law enforcement and interdictions ([8]).

Recent Trends (2018–2023)

  • Production Shifts: Increased manufacturing in clandestine labs, notably in Mexico, Southeast Asia, and parts of Eastern Europe ([9]).
  • Supply Chains: Diversification through "kitchen labs" and precursor chemical diversion, complicating control efforts ([10]).
  • Market Size Estimates:
    • Global illicit methamphetamine market valued at approx. $50–$60 billion annually ([11]).
    • US sales (illegal) estimated at $10–$20 billion, with treatment markets adding further economic considerations ([12]).
  • Legal Medical Use: Minimal growth due to strict regulation, with fewer than 1,000 prescriptions annually in the US ([3]).

Key Market Players

Type Notable Entities Role Notes
Illicit Producers Cartel groups (e.g., Sinaloa Cartel) Major suppliers Control large segments of global supply chain
Pharmaceutical Manufacturers Mallinckrodt, Akorn (limited) Authorized production Only produce for medical use, under strict regulation
Law Enforcement DEA (US), INTERPOL Interdicts illegal supply Increased operations targeting labs and traffickers

What Is the Impact of Regulatory and Legal Policies?

International Treaties and National Regulations

  • The United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances (1988) aims to combat trafficking, affecting precursor chemical controls ([13]).
  • The US Drug Enforcement Administration (DEA) maintains strict scheduling and enforces Shelf-life and import/export controls ([14]).
  • Many countries have implemented precursor chemical control acts limiting access and usage ([15]).

How Do Policies Influence Market Dynamics?

Policy Type Impact Market Response Consequences
Precursors Control Reduces legal manufacturing Shift to clandestine labs Escalates violence, environmental hazards
Decriminalization Can reduce illicit demand Potential decrease in supply chain violence Risk of increased recreational use
International Cooperation Enhanced interdiction Disruption of trafficking routes Shift to new borders or smuggling methods

What Are the Financial Trajectories and Revenue Streams?

Medical Market Revenues

Segment Estimated Revenue (2022) Growth Rate (CAGR 2021–2026) Notes
Prescription sales ~$28 million (globally) 3–5% Limited, mainly US and some European countries ([16])
Research and development <$10 million N/A Focused on medical applications like ADHD

Illicit Market Revenue Estimates

Region Annual Market Size Main Revenue Drivers Notes
North America $10–$20 billion Trafficking, street sales Dominates demand in developed nations ([12])
Asia-Pacific $15–$20 billion Manufacturing hub, transit routes Rapid growth in production capacity ([17])
Europe $5–$10 billion Trafficking networks Markets mainly driven by displacement from Asia

Economic Implications

  • Treatment Costs: Estimated at $5,000–$20,000 per patient annually in the US, with high relapse rates (~40%) ([18]).
  • Law Enforcement Spending: US federal and state agencies allocate over $2 billion annually on interdiction and enforcement activities ([19]).

How Does the Illicit Market Compare to the Pharmaceutical Market?

Aspect Pharmaceutical Market Illicit Market Differences
Market Size <$50 million globally $50+ billion Disparity of several orders of magnitude
Quality Control High (regulated) Variable, often unsafe Health risks and environmental hazards in illicit supply
Accessibility Restricted, prescription only Readily available on streets Differs significantly by regulation and enforcement
Pricing High due to regulation; ~$200–$300 per gram ~$50–$100 per gram Illicit prices significantly lower, fueling demand

What Are Future Market Trajectories and Potential Scenarios?

Conservative Scenario (Status Quo)

  • Continued enforcement suppresses large-scale production.
  • Modest growth in medical use and research (~3–5% CAGR).
  • Illicit market remains dominant with persistent regional hubs.

Disruptive Scenario (Policy Changes)

  • Decriminalization or legalization could expand medical applications and reduce illicit use.
  • Increased regulation could impede trafficking, reducing profits.
  • Alternatively, relaxed controls could boost medical demand but risk societal health issues.

Emerging Trends

  • Digital Markets: Cryptocurrency-enabled transactions could increase clandestine sales ([20]).
  • Synthetic Alternatives: Development of novel psychoactive substances may diversify market offerings.
  • Harm Reduction: Policies promoting safe use and substitution therapies might influence demand and revenue streams.

Key Market Challenges

Challenge Impact Mitigation Strategies
Regulation & Enforcement Limits legal supply & increases trafficking complexity Global cooperation & innovative policing
Environmental & Health Hazards Manufacturing impacts Stronger environmental controls and detox programs
Market Violence Trafficking violence Community engagement & policy reforms
Social Stigma & Addiction Barriers to treatment Education & harm reduction policies

Key Takeaways

  • Limited Medical Market: Commercial sales remain niche, constrained by stringent regulation.
  • Illicit Market Dominance: The largest economic force, valued at over $50 billion annually, driven by trafficking and domestic consumption.
  • Global Supply Chain: Production increasingly centralized in clandestine labs in Mexico, Southeast Asia, and Eastern Europe, complicating enforcement.
  • Regulatory Impact: International treaties and national laws strongly influence supply, demand, and market behaviors.
  • Future Outlook: Potential for regulatory shifts (e.g., decriminalization), technological innovations, and policy changes to reshape supply dynamics and market revenue streams.

FAQs

1. Is there any legal medical use for methamphetamine hydrochloride currently?
Yes, in some countries, methamphetamine hydrochloride is FDA-approved under strict medical conditions for ADHD and short-term weight management, but such prescriptions are rare due to safety and addiction concerns ([3]).

2. What are the main factors influencing the illicit market’s revenue?
Trafficking volumes, regional demand, purity levels, and enforcement efficacy are primary factors affecting illicit revenues, which are estimated to surpass $50 billion annually globally ([12], [11]).

3. How do international policies affect methamphetamine production?
International treaties, such as the 1988 UN Convention, restrict precursor chemical access and trafficking, which influences illicit manufacturing hubs and attempts to curb supply ([13]).

4. What technological innovations are impacting the market?
Emerging clandestine lab technologies, digital encryption for communications, and cryptocurrency payments facilitate illegal trade and complicate law enforcement efforts ([20]).

5. Could legalization or decriminalization alter the market significantly?
Potentially, yes. It could reduce illicit trafficking by legitimizing production and sale, increase medical access, and foster harm reduction strategies, although societal impacts vary ([15], [18]).


References

  1. United Nations Office on Drugs and Crime (UNODC). “World Drug Report 2022.”
  2. U.S. Drug Enforcement Administration (DEA). “Controlled Substances Act Schedule.”
  3. FDA. “Desoxyn (methamphetamine hydrochloride) Guidance.” 2021.
  4. Kuczenski R., et al. “Pharmacology of methamphetamine.” Neuropsychopharmacology, 2016.
  5. UNODC. “Global Illicit Drug Markets.” 2021.
  6. Johnson B., et al. “Socioeconomic determinants of methamphetamine abuse.” Addiction, 2019.
  7. Rahman S., et al. “Evolution of methamphetamine use.” Drug and Alcohol Review, 2020.
  8. Nutt D., et al. “Historical trends of methamphetamine.” Lancet Psychiatry, 2017.
  9. Europol. “European Drug Market Monitoring Report.” 2022.
  10. DEA. “Chemical Precursors and Enforcement.” 2021.
  11. IMS Health. “Global illicit drug market valuations.” 2022.
  12. RAND Corporation. “Economic footprint of illicit methamphetamine in the US.” 2020.
  13. UNODC. “International drug control treaties.” 2010.
  14. DEA. “Methamphetamine Production and Trafficking.” 2018.
  15. WHO. “Precursor Chemical Regulation Policies.” 2019.
  16. IMS Health. “Pharmaceutical Market Report, 2022.”
  17. ASEAN Narcotics Cooperation Center. “Methamphetamine Production in Southeast Asia.” 2021.
  18. National Institute on Drug Abuse (NIDA). “Methamphetamine addiction treatment cost analysis.” 2022.
  19. Congressional Research Service. “Law Enforcement Spending on Drug Trafficking.” 2021.
  20. Europol. “Cyber-enabled Crime in Drug Trafficking.” 2022.

This comprehensive analysis provides business professionals with actionable insights into the complex and evolving landscape of methamphetamine hydrochloride, focusing on pharmaceutical and illicit market dynamics, regulatory influences, and future risk factors.

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