MYDAYIS Drug Patent Profile

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

Mydayis is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are two patents protecting this drug and two Paragraph IV challenges.

The generic ingredient in MYDAYIS is amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate. There are fifty-five drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate profile page.

DrugPatentWatch^® Generic Entry Outlook for Mydayis

There have been fifteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for MYDAYIS

US Patents:	2
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MYDAYIS

Paragraph IV (Patent) Challenges for MYDAYIS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MYDAYIS	Extended-release Capsules	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	12.5 mg and 25 mg	022063	1	2017-08-07
MYDAYIS	Extended-release Capsules	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	37.5 mg and 50 mg	022063	1	2017-08-03

US Patents and Regulatory Information for MYDAYIS

MYDAYIS is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	MYDAYIS	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	022063-001	Jun 20, 2017	AB2	RX	Yes	No
Takeda Pharms Usa	MYDAYIS	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	022063-004	Jun 20, 2017	AB2	RX	Yes	Yes
Takeda Pharms Usa	MYDAYIS	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	022063-002	Jun 20, 2017	AB2	RX	Yes	No			Y
Takeda Pharms Usa	MYDAYIS	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	022063-004	Jun 20, 2017	AB2	RX	Yes	Yes			Y
Takeda Pharms Usa	MYDAYIS	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	022063-001	Jun 20, 2017	AB2	RX	Yes	No			Y

International Patents for MYDAYIS

See the table below for patents covering MYDAYIS around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1542660	ADMINISTRATION PAR LIBERATION PROLONGEE DE SELS D'AMPHETAMINE (SUSTAINED RELEASED DELIVERY OF AMPHETAMINE SALTS)
Israel	167470	PHARMACEUTICAL COMPOSITION FOR SUSTAINED RELEASED DELIVERY OF AMPHETAMINE SALTS
Cyprus	1112335
African Intellectual Property Organization (OAPI)	13075	Sustained released delivery of amphetamine salts.
Denmark	1542660

MYDAYIS Investment and Fundamentals Analysis

Last updated: February 20, 2026

What is MYDAYIS?

MYDAYIS (amphetamine extended-release) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) in 2017 for treating attention deficit hyperactivity disorder (ADHD) in adolescents age 13 and above, and adults. It is marketed by Neos Therapeutics, now part of Supernus Pharmaceuticals following strategic acquisitions.

Market Overview

Market Size and Growth

• The global ADHD drug market was valued at approximately USD 20 billion in 2021.
• Compound annual growth rate (CAGR) projected at 6.2% through 2028[1].
• North America accounts for over 75% of the market, driven by high diagnosis rates and healthcare access.

Competitive Landscape

• Key competitors include brands such as Adderall XR (was Shire, now part of Takeda), Vyvanse (Lilly), and Concerta (J&J).
• MYDAYIS competes as an extended-release formulation of amphetamine salts, similar in profile to Adderall XR but with a longer duration (up to 14 hours).

Product Profile and Differentiators

• Administration: One daily dose.
• Duration: Up to 14 hours.
• Formulation: Contains mixed amphetamine salts (AMS).
• Dosing flexibility: Available in 12.5 mg to 50 mg tablets.
• Patent and exclusivity status: Patent protection until at least 2030; exclusivity periods via FDA regulatory designations.

Revenue Drivers

• Prescribing trends: Increasing ADHD diagnosis prevalence (estimated at 10.5% among children aged 4-17 in the U.S. in 2020[2]).
• Compliance: Extended-release formulations enhance adherence.
• Market penetration: Limited market share (~1-2% among stimulant meds) indicates growth potential.

Financial Fundamentals

Sales and Revenue

• Neos Therapeutics reported peak MYDAYIS revenue of approximately USD 50 million in 2019.
• Post-acquisition by Supernus, detailed sales figures aggregate into broader CNS portfolios.

Cost Structure

• R&D: Ongoing efforts to develop differentiated formulations.
• Marketing: Focused on neurologists, psychiatrists, pediatricians.
• Manufacturing: Cost-efficient due to established formulations; scale effects reduce unit costs.

Patents and Regulatory Status

• Patent protection until 2030[3].
• No current generic equivalents approved; potential entry risk modulated by patent challenges.

Investment Risks and Barriers

• Regulatory: Possible patent disputes or delays in approvals for generics.
• Competition: Diversification of treatment options (non-stimulant medications) can limit growth.
• Market saturation: High prescriber familiarity with established brands.

Strategic Positioning

• Medical differentiation: Slightly longer duration may appeal to certain patient segments.
• Lifecycle management: Potential for new formulations or combination therapies to extend product lifecycle.
• Collaborations: Opportunities for partnerships with healthcare providers and payers to improve access.

Investment Outlook

Strengths

• Patent exclusivity until 2030.
• Growing ADHD diagnosis rates.
• Established market presence with steady prescriber base.

Weaknesses

• Limited market share relative to larger competitors.
• Dependence on stimulant guidelines which face scrutiny due to abuse potential.
• Limited geographic footprint; primarily U.S.-focused.

Opportunities

• Expansion into adult ADHD markets.
• Development of novel formulations or combinations.
• Increased marketing efforts in underserved patient populations.

Threats

• Entry of generic competitors post-patent expiration.
• Regulatory shifts affecting stimulant medication prescribing.
• Public health policies targeting abuse prevention.

Key Takeaways

• MYDAYIS operates in a competitive and growing ADHD drug market, with patent protection until 2030 supporting revenue sustainability.
• The product’s differentiation hinges on its extended duration, catering to patients requiring longer symptom control.
• Revenue contribution remains modest but offers growth potential given rising diagnosis rates and limited current market penetration.
• Investment risks include patent challenges and market share erosion by generics.
• Strategic initiatives focusing on adult ADHD and formulation innovation could improve long-term competitiveness.

FAQs

1. What is the primary advantage of MYDAYIS over other ADHD medications?
   Its extended release duration up to 14 hours provides all-day symptom control, reducing the need for multiple doses.

2. When can generic versions of MYDAYIS be expected?
   Patent protection lasts until at least 2030; generics could enter the market afterward, contingent on patent challenges and regulatory approvals.

3. How significant is MYDAYIS’s market share in the ADHD drug market?
   It holds around 1-2%, indicating niche status but room for growth through targeted marketing and new indications.

4. What are the main risks to investing in MYDAYIS?
   Patent expiry, increased competition from generics, regulatory scrutiny, and shifting prescribing guidelines are primary risks.

5. Could regulatory changes impact MYDAYIS’s future sales?
   Yes. Policies aimed at reducing stimulant misuse or favoring non-stimulant treatments could decrease prescribing volume.

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References

[1] Grand View Research. (2022). ADHD drugs market size, share & trends analysis.
[2] Centers for Disease Control and Prevention. (2021). ADHD prevalence among children.
[3] U.S. Patent and Trademark Office. (2023). Patent database for MYDAYIS.