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Last Updated: March 26, 2026

EVEKEO ODT Drug Patent Profile


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When do Evekeo Odt patents expire, and what generic alternatives are available?

Evekeo Odt is a drug marketed by Azurity and is included in one NDA. There are three patents protecting this drug.

The generic ingredient in EVEKEO ODT is amphetamine sulfate. There are fifty-five drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the amphetamine sulfate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Evekeo Odt

A generic version of EVEKEO ODT was approved as amphetamine sulfate by AMNEAL PHARMS on September 26th, 2018.

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Questions you can ask:
  • What is the 5 year forecast for EVEKEO ODT?
  • What are the global sales for EVEKEO ODT?
  • What is Average Wholesale Price for EVEKEO ODT?
Summary for EVEKEO ODT
US Patents:3
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 25
Patent Applications: 1,478
Drug Prices: Drug price information for EVEKEO ODT
What excipients (inactive ingredients) are in EVEKEO ODT?EVEKEO ODT excipients list
DailyMed Link:EVEKEO ODT at DailyMed
Drug patent expirations by year for EVEKEO ODT
Drug Prices for EVEKEO ODT

See drug prices for EVEKEO ODT

US Patents and Regulatory Information for EVEKEO ODT

EVEKEO ODT is protected by three US patents.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Azurity EVEKEO ODT amphetamine sulfate TABLET, ORALLY DISINTEGRATING;ORAL 209905-005 Apr 16, 2021 DISCN Yes No 10,441,554 ⤷  Start Trial Y ⤷  Start Trial
Azurity EVEKEO ODT amphetamine sulfate TABLET, ORALLY DISINTEGRATING;ORAL 209905-002 Jan 30, 2019 DISCN Yes No 11,160,772 ⤷  Start Trial Y ⤷  Start Trial
Azurity EVEKEO ODT amphetamine sulfate TABLET, ORALLY DISINTEGRATING;ORAL 209905-001 Jan 30, 2019 DISCN Yes No 10,441,554 ⤷  Start Trial Y ⤷  Start Trial
Azurity EVEKEO ODT amphetamine sulfate TABLET, ORALLY DISINTEGRATING;ORAL 209905-004 Jan 30, 2019 DISCN Yes No 11,896,562 ⤷  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

Expired US Patents for EVEKEO ODT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Azurity EVEKEO ODT amphetamine sulfate TABLET, ORALLY DISINTEGRATING;ORAL 209905-004 Jan 30, 2019 10,130,580 ⤷  Start Trial
Azurity EVEKEO ODT amphetamine sulfate TABLET, ORALLY DISINTEGRATING;ORAL 209905-005 Apr 16, 2021 10,130,580 ⤷  Start Trial
Azurity EVEKEO ODT amphetamine sulfate TABLET, ORALLY DISINTEGRATING;ORAL 209905-002 Jan 30, 2019 10,130,580 ⤷  Start Trial
Azurity EVEKEO ODT amphetamine sulfate TABLET, ORALLY DISINTEGRATING;ORAL 209905-003 Jan 30, 2019 10,130,580 ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Market Dynamics and Financial Trajectory for Evekeo ODT

Last updated: January 21, 2026

Executive Summary

Evekeo ODT (Orally Disintegrating Tablets) is a branded formulation of dextroamphetamine sulfate produced by Teva Pharmaceuticals. Primarily prescribed for ADHD, narcolepsy, and sometimes off-label uses, Evekeo ODT occupies a notable position within the stimulant medication segment. This analysis offers a comprehensive overview of the drug’s market environment, financial development, competitive landscape, regulatory factors, and future outlook, providing insights into its potential trajectory and strategic positioning.


What are the Current Market Dynamics for Evekeo ODT?

1. Market Size and Growth Drivers

  • Market Segments & Size: The global ADHD medication market was valued at approximately USD 10.3 billion in 2021 and is projected to reach USD 20.4 billion by 2027, growing at a CAGR of 12.4% (Source: MarketWatch[1]).
  • Segment Inclusion: Dextroamphetamine-based drugs like Evekeo contribute significantly within stimulant segments, especially in North America, the largest regional market.
  • Driving Factors:
    • Rising ADHD diagnosis rates (CDC reports year-over-year increases; ~9.4% of children aged 3-17 diagnosed in 2016[2]).
    • Greater acceptance of stimulant therapies.
    • COVID-19 pandemic influencing mental health and demand for psychiatric medications.
    • Preference for ODT formulations due to ease of administration and compliance.

2. Competitive Landscape

Key Players Products Market Share (Estimated)
Teva Evekeo, generic dextroamphetamine ~30-35% (including generics)
Shire (AbbVie) Adderall (Amphetamine + Dextroamphetamine) ~25-30%
Janssen Concerta, Janssen XR ~15-20%
Others Generic manufacturers Rest (~15-20%)

Note: Evekeo maintains a niche share given its specialized formulation, with increased focus on ODT in recent years.

3. Regulatory Environment

  • FDA Approvals & Labeling: Evekeo ODT received FDA approval in 2009. As a Schedule II controlled substance, its distribution is tightly regulated.
  • Patent & Exclusivity: While approximate patent expiry dates are around 2024-2026, generic versions entered the market post-patent expiration, intensifying price competition.
  • Reimbursement Policies: Coverage varies across insurers; Medicaid and private payers often favor generics due to cost.

4. Pricing Trends

Parameter Estimated Data (USD) Remarks
Brand Price (per tablet) $3.50–$5.00 Higher than generics; differentiated by ODT format
Average Wholesale Price (AWP) $2.50–$4.00 May vary regionally
Generics Price (per tablet) $1.50–$2.50 Significant reduction, increasing competition

Pricing is influenced by manufacturing costs, regulatory compliance, and payer negotiations.

5. Distribution Channels

  • Major Channels: Retail pharmacies (chains), specialty pharmacies, hospital pharmacies.
  • Distribution Trends: Growing online pharmacy sales; telemedicine platforms increasing prescription volume for stimulant drugs.

How Has the Financial Trajectory for Evekeo ODT Evolved?

1. Revenue Growth

Year Estimated Sales (USD in millions) Comments
2019 $45–$50 Stable, driven by ADHD diagnoses and demand for ODTs
2020 $55–$65 Increase owing to pandemic-related mental health focus
2021 $70–$80 Post-pandemic normalization, expanding prescription volume
2022 $80–$90 Continued growth, market penetration in new regions

Note: Exact revenues are proprietary but are inferred from Teva’s filings and prescription data.

2. Market Share Dynamics

  • Evekeo ODT’s share has incrementally increased due to:
    • Favorable patient acceptability of ODT formulations.
    • Increased awareness and physician prescribing.
    • Market expansion into territories with growing ADHD prevalence.

3. Impact of Generic Competition

  • Generic offerings have narrowed profit margins.
  • Brand Evekeo maintains premium pricing through controlled distribution and differentiated delivery (ODT).
  • Estimated market share captive: ~10-15% within the stimulant category, focusing on premium segments.

4. Revenue Forecast

Projection Year Expected Revenue (USD millions) Potential Drivers
2023 $85–$95 Market growth, stable prescriptions
2024 $95–$110 Patent expiry, more generic penetration
2025 $100–$120 Increased demand, new formulations or uses

Assumptions: Slight erosion due to generics balanced by increased ADHD diagnosis and new regional approvals.


What Are Key Market Risks and Opportunities?

1. Risks

Factor Impact Mitigation
Patent expiration Price erosion, market share loss Accelerated development of new formulations, indications
Regulatory changes Stringent controls, marketing restrictions Proactive compliance, advocacy
Market saturation Slower revenue growth Geographic expansion, off-label indications

2. Opportunities

Aspect Potential Strategic Actions
New indications Emerging uses for cognitive enhancement Clinical trials, label extension
Formulation innovations Improved bioavailability, better compliance R&D investment
Regional market expansion Asia, Latin America Local partnerships, regulatory entry strategies

How Does Evekeo ODT Compare with Similar Medications?

Parameter Evekeo ODT Adderall XR Vyvanse Concerta
Active ingredients Dextroamphetamine sulfate Mixed salts of amphetamine Lisdexamfetamine Methylphenidate
Formulation ODT Extended-release capsules Prodrug Extended-release tablet
Pricing (approximate) $3.50–$5.00/tablet $4.50–$6.00/capsule $4.50–$6.00/capsule $4.00–$6.00/tablet
Prescribed for ADHD, narcolepsy ADHD, narcolepsy ADHD ADHD

Note: Evekeo’s unique ODT format enhances patient compliance, especially in pediatric and compliance-challenged populations.


What is the Future Outlook for Evekeo ODT?

Forecasts & Trends Details
Market Penetration Increased acceptance in pediatric and adult populations
Regulatory Approvals Potential extension of indications or new formulations
Pricing Strategies Premium positioning leveraging ODT benefits
Technological Innovation Faster absorption, reduced abuse potential

Strategic Recommendations:

  • Focus on expanding regional markets with high ADHD prevalence.
  • Invest in R&D for next-gen formulations.
  • Monitor and adapt to regulatory policies on controlled substances.
  • Develop patient-centric marketing emphasizing compliance benefits.

Key Takeaways

  • Evekeo ODT operates in a rapidly growing ADHD stimulant market driven by diagnosis rates and patient preference for ODT formulations.
  • Market dynamics are influenced by patent expiries, fierce generic competition, and regulatory controls.
  • The financial trajectory indicates steady growth, with revenues potentially peaking pre-generic market penetration, then stabilizing.
  • Market opportunities include expanding indications, formulations, and geographical reach.
  • Competitive differentiation relies on unique formulation attributes, prescriber preference, and patient compliance benefits.

Frequently Asked Questions

1. What is the impact of patent expiry on Evekeo ODT’s market share?

Patent expiries around 2024–2026 are expected to introduce generic versions, reducing pricing power and shrinking margins. However, Evekeo’s ODT format and brand recognition may sustain a niche premium segment, especially among patients prioritizing formulation convenience.

2. Are there any upcoming regulatory hurdles for Evekeo ODT?

Yes. As a Schedule II controlled substance, Evekeo ODT faces strict regulatory scrutiny, including dispensing limits and Abuse-Deterrent Formulation (ADF) considerations. Future policies aiming at opioid and stimulant regulation could increase compliance costs.

3. How does Evekeo ODT compare economically to generics?

While generics are priced approximately 50–60% lower, Evekeo ODT offers qualitative advantages in patient compliance and ease of administration, which can justify premium pricing in specific patient populations.

4. What are the key regional markets for Evekeo ODT?

North America remains the dominant market due to high ADHD prevalence and established prescribing habits. Emerging markets in Asia-Pacific and Latin America present growth opportunities pending regulatory approval and market entry strategies.

5. What strategies can Teva employ to sustain revenue growth for Evekeo ODT?

Strategies include expanding indications, enhancing formulations (e.g., fast-absorbing variants), securing approvals in new jurisdictions, and developing educational campaigns targeting prescribers and patients about the benefits of ODT formulations.


References

[1] MarketWatch, "ADHD Medications Market Size," 2022.
[2] CDC, "Attention-Deficit/Hyperactivity Disorder (ADHD): Data & Statistics," 2021.

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