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Last Updated: March 26, 2026

DESOXYN Drug Patent Profile


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Which patents cover Desoxyn, and what generic alternatives are available?

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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Questions you can ask:
  • What is the 5 year forecast for DESOXYN?
  • What are the global sales for DESOXYN?
  • What is Average Wholesale Price for DESOXYN?
Summary for DESOXYN
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 33
Clinical Trials: 5
Patent Applications: 3,293
Drug Prices: Drug price information for DESOXYN
What excipients (inactive ingredients) are in DESOXYN?DESOXYN excipients list
DailyMed Link:DESOXYN at DailyMed
Drug patent expirations by year for DESOXYN
Drug Prices for DESOXYN

See drug prices for DESOXYN

Recent Clinical Trials for DESOXYN

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

SponsorPhase
University of California, San FranciscoPhase 4
National Institute on Drug Abuse (NIDA)Phase 4
Oregon Health and Science UniversityPhase 4

See all DESOXYN clinical trials

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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Ajenat Pharms DESOXYN methamphetamine hydrochloride TABLET;ORAL 005378-002 Approved Prior to Jan 1, 1982 AA RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Ajenat Pharms DESOXYN methamphetamine hydrochloride TABLET, EXTENDED RELEASE;ORAL 005378-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Ajenat Pharms DESOXYN methamphetamine hydrochloride TABLET, EXTENDED RELEASE;ORAL 005378-005 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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 DESOXYN

Last updated: February 20, 2026

What Is DESOXYN and Its Current Market Position?

DESOXYN is a pharmaceutical compound primarily developed as a combination treatment for depression and anxiety disorders. Its active ingredient is desoxyn, a synthetic form of methamphetamine, marketed under various formulations. The drug has historically been used for ADHD, obesity, and certain psychiatric conditions. Recent regulatory shifts and clinical trial outcomes influence its position within the psypharmaceutical market.

Regulatory Status

  • FDA Approval: FDA approved DESOXYN for ADHD and short-term obesity management in the 1950s.
  • Reclassification: The Drug Enforcement Administration (DEA) classifies DESOXYN as Schedule II due to high abuse potential.
  • Market Restrictions: Use is limited to authorized medical contexts; off-label use faces regulatory crackdowns.

Market Share

  • The global market for stimulant medications, including DESOXYN, was valued at approximately USD 2.7 billion in 2022.
  • DESOXYN specific sales represent less than 2% of this market, primarily due to limited approval and high abuse concerns.

How Do Market Dynamics Affect DESOXYN?

Market Drivers

  • Rise in ADHD diagnoses, particularly in adolescents and adults, increases demand for stimulant therapies.
  • Growing awareness and destigmatization of mental health disorders expand prescription volume.
  • Advances in formulation technology enable extended-release options, broadening therapeutic applications.

Market Constraints

  • Stringent regulations result in limited prescribing due to abuse potential and regulatory oversight.
  • The availability of alternative medications, such as methylphenidate and modafinil, offers competitive options.
  • Public health initiatives aim to reduce stimulant misuse, impacting sales volume.

Competitive Landscape

Key Competitors Market Focus Market Share (2022) Differentiators
Methylphenidate (Ritalin) ADHD, narcolepsy 40% Long history, established safety profile
Amphetamine (Adderall) ADHD, narcolepsy 35% Widely prescribed, flexible formulations
Modafinil (Provigil) Narcolepsy, shift work sleep disorder 10% Lower abuse potential, wakefulness promotion
DESOXYN ADHD, obesity, off-label uses <2% High abuse potential, limited applications

What Is the Financial Outlook for DESOXYN?

Revenue Projections

  • US sales are estimated to be around USD 50 million annually, based on prescription data and FDA scheduled approvals.
  • Market potential could reach USD 150 million if regulatory constraints ease and off-label uses expand.
  • Growth hinges on regulatory acceptance, clinical validation, and market penetration.

Cost Structure and Pricing

  • Average wholesale price per dose: USD 10–15 for branded formulations.
  • Manufacturing costs: USD 2–4 per unit, considering high-potency synthesis and strict quality controls.
  • R&D investment: Historically, minimal due to established patent protections. Future R&D for new formulations could require USD 50-100 million.

Investment and R&D Trends

  • Pharmaceutical firms focus R&D on abuse-deterrent formulations and extended-release variants.
  • Trials for novel applications in treatment-resistant depression are underway but have yet to demonstrate conclusive benefits.
  • Licensing agreements are common, with major pharma firms acquiring rights for niche markets or research.

Why Do Market and Financial Factors Matter?

  • Regulatory changes could dramatically shift market share and profitability. Deregulation or tighter controls directly affect revenue streams.
  • Competition's movement into the stimulant space influences pricing, market access, and physician prescribing habits.
  • Investment in R&D signals future growth or obsolescence; sustained or increased funding indicates potential market expansion.

Key Market Trends and Predictions

  • Increased prescribing of stimulants in mental health treatment plans may marginally raise DESOXYN's market share if regulatory hurdles decline.
  • Emerging formulations with abuse-deterrent properties could command premium pricing and foster niche markets.
  • The global push toward handling substance abuse issues encourages stricter controls, limiting growth.

Key Takeaways

  • DESOXYN's market is constrained by regulatory controls and high abuse potential, limiting sales compared to competitors.
  • The global stimulant market was valued at USD 2.7 billion in 2022, with DESOXYN constituting under 2%.
  • Revenue projections hover around USD 50 million annually; growth depends on regulatory relaxations and clinical success.
  • R&D efforts are mainly focused on abuse-deterrent and extended-release formulations, with hundreds of millions of dollars invested in future potential products.
  • Competitive pressures from methylphenidate, adderall, and newer agents provide ongoing challenges and opportunities for niche applications.

FAQs

Q1: What are the main regulatory risks facing DESOXYN?
A1: The primary risk involves DEA scheduling changes, which could restrict or expand access, affecting sales. Regulatory crackdowns on misuse may also limit prescribing practices.

Q2: How does DESOXYN compare price-wise to its competitors?
A2: The average wholesale price per dose of DESOXYN ranges from USD 10–15, generally higher than methylphenidate but comparable to or below newer formulations.

Q3: Is there potential for DESOXYN in off-label applications?
A3: Some research investigates off-label use in treatment-resistant depression, but regulatory and safety concerns limit widespread adoption.

Q4: What are the main alternatives to DESOXYN in the stimulant market?
A4: Methylphenidate (Ritalin), amphetamine-based drugs (Adderall), and modafinil are primary competitors, each with distinct safety, efficacy, and regulatory profiles.

Q5: How does abuse potential impact DESOXYN's market share?
A5: High abuse potential leads to tighter regulation and reduced prescriber willingness, limiting market share expansion despite clinical demand.


References

  1. U.S. Food and Drug Administration (FDA). (2022). Approved Drug Products. Retrieved from https://www.accessdata.fda.gov/scripts/cder/daf/
  2. Substance Abuse and Mental Health Services Administration. (2022). National Survey on Drug Use and Health.
  3. MarketWatch. (2023). Global stimulants market report.
  4. DEA. (2023). Schedules of controlled substances. Retrieved from https://www.deadiversion.usdoj.gov/schedules/
  5. IQVIA. (2022). Prescription Data for Stimulant Medications.

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