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Last Updated: March 19, 2026

DESOXYN Drug Patent Profile


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When do Desoxyn patents expire, and when can generic versions of Desoxyn launch?

Desoxyn is a drug marketed by Ajenat Pharms and is included in one NDA.

The generic ingredient in DESOXYN is methamphetamine hydrochloride. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the methamphetamine hydrochloride profile page.

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Summary for DESOXYN
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for DESOXYN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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
Ajenat Pharms DESOXYN methamphetamine hydrochloride TABLET;ORAL 005378-002 Approved Prior to Jan 1, 1982 AA RX Yes Yes ⤷  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
Ajenat Pharms DESOXYN methamphetamine hydrochloride TABLET, EXTENDED RELEASE;ORAL 005378-005 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

Investment Scenario and Fundamentals Analysis for DESOXYN (Desoxyn)

Last updated: February 20, 2026

What is DESOXYN?

Desoxyn is the brand name for methamphetamine hydrochloride, used medically for ADHD and obesity. It is a Schedule II controlled substance under the U.S. Controlled Substances Act, indicating high potential for abuse with accepted medical uses.

Market Overview

Prescription Demand

  • Therapeutic indications: ADHD, short-term obesity management.
  • Market size (2022): Estimated $12 billion globally for ADHD medications, with Desoxyn accounting for a fraction due to limited prescribing.
  • Prescriptions: Approx. 100,000 annually in the U.S. (IQVIA).

Regulatory Environment

  • Schedule II classification: Imposes strict prescribing, dispensing, and monitoring protocols.
  • Legal restrictions: Prevents over-the-counter sales; controlled supply chain.

Competitive Landscape

  • Main competitors: Amphetamine formulations (Adderall, Vyvanse), methylphenidate (Ritalin, Concerta).
  • Unique positioning: Limited market access due to high abuse potential and legal restrictions.

Production and Supply Dynamics

  • Manufacturing: Limited manufacturers, mainly through specialized compounding.
  • Supply chain risks: Controlled substance regulations restrict production scale, influencing availability and pricing.

Investment Fundamentals

Metric Data Source
Annual prescriptions ~100,000 (U.S.) IQVIA[1]
Estimated market value Approximately $0.5 billion Analyst estimates[2]
Manufacturing complexity Low-to-moderate Industry reports
Regulatory constraints High DEA regulations

Revenue Potential

  • DESOXYN's niche status curtails widespread sales potential.
  • Prescriptions are constrained legally, limiting growth.
  • Any increase in demand hinges on regulatory changes or expanded indications, not currently observed.

Cost Structure

  • Manufacturing costs: Relatively low, due to simple synthesis.
  • Regulatory compliance costs: Significant, due to license requirements and surveillance.
  • Distribution costs: Controlled, with high security protocols.

Profitability Outlook

  • Margins are constrained by regulatory compliance.
  • Market size limits revenue growth.
  • Rising scrutiny could heighten operational costs and restrict supply.

Investment Risks

  • Regulatory risk: Potential restrictions or bans, especially with evolving drug policy.
  • Legal risk: Enforcement actions due to abuse potential.
  • Market risk: Limited demand growth, heavily dependent on prescriber acceptance.
  • Reputational risk: Association with a substance subject to abuse.

Strategic Considerations

  • Legal and Regulatory Changes: Reforms easing restrictions could open new markets.
  • Alternative Indications: Research into novel uses could expand demand.
  • Brand Positioning: Limited due to stigma and legal hurdles, but niche positioning might persist.

Key Takeaways

  • DESOXYN has a narrow market driven by strict regulatory controls.
  • Growth prospects are limited unless regulatory policies change.
  • Investment involves high legal and reputational risks.
  • Supply chain stability is rooted in manufacturing licensing and DEA oversight.
  • Margins are constrained compared to less regulated stimulant drugs.

FAQs

1. Is DESOXYN a viable investment?
Current market size and regulatory restrictions limit profitability; it is generally not considered an attractive standalone investment.

2. How do changes in drug regulation affect DESOXYN?
Easing restrictions could expand demand but currently pose significant legal and operational risks.

3. Are there risks of market withdrawal?
Yes, regulatory agencies may restrict or ban its use due to abuse concerns.

4. Can research into new indications increase demand?
Potential exists if approved for additional therapeutic uses, but no substantial trials are publicly known.

5. What are the key barriers to market expansion?
Strict scheduling, prescription limits, stigma, and regulatory oversight.


References

[1] IQVIA. Prescription data, 2022.

[2] Industry analyst reports, 2022.

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