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
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
Drug Prices:	Drug price information for MYDAYIS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MYDAYIS
What excipients (inactive ingredients) are in MYDAYIS?	MYDAYIS excipients list
DailyMed Link:	MYDAYIS at DailyMed

See drug prices for MYDAYIS

Recent Clinical Trials for MYDAYIS

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

Sponsor	Phase
Mayo Clinic	Phase 2
Lindner Center of HOPE	Phase 2
New York University School of Medicine	Phase 3

See all MYDAYIS clinical trials

Pharmacology for MYDAYIS

Drug Class	Central Nervous System Stimulant
Physiological Effect	Central Nervous System Stimulation

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
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
Takeda Pharms Usa	MYDAYIS	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	022063-003	Jun 20, 2017	AB2	RX	Yes	No			Y

Expired US Patents for MYDAYIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	MYDAYIS	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	022063-002	Jun 20, 2017
Takeda Pharms Usa	MYDAYIS	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	022063-001	Jun 20, 2017
Takeda Pharms Usa	MYDAYIS	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	022063-004	Jun 20, 2017
Takeda Pharms Usa	MYDAYIS	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	022063-004	Jun 20, 2017
Takeda Pharms Usa	MYDAYIS	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	022063-003	Jun 20, 2017
Takeda Pharms Usa	MYDAYIS	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	022063-004	Jun 20, 2017
Takeda Pharms Usa	MYDAYIS	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	022063-003	Jun 20, 2017

International Patents for MYDAYIS

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

Country	Patent Number	Title	Estimated Expiration
Canada	2499546	ADMINISTRATION PAR LIBERATION PROLONGEE DE SELS D'AMPHETAMINE (SUSTAINED RELEASED DELIVERY OF AMPHETAMINE SALTS)
New Zealand	539216	Sustained released delivery of amphetamine salts
Australia	1214500
Hong Kong	1075828	SUSTAINED RELEASED DELIVERY OF AMPHETAMINE SALTS
Morocco	27469	ADMINISTRATION PAR LIBERATION PROLONGEE DE SELS D'AMPHETAMINE.
Spain	2360046
European Patent Office	1542660	ADMINISTRATION PAR LIBERATION PROLONGEE DE SELS D'AMPHETAMINE (SUSTAINED RELEASED DELIVERY OF AMPHETAMINE SALTS)

MYDAYIS: Market Dynamics and Financial Trajectory

Last updated: February 20, 2026

MYDAYIS (mixed amphetamine salts extended-release) is a prescription medication approved by the FDA for attention deficit hyperactivity disorder (ADHD) and binge eating disorder in adults. Its market performance and financial trajectory depend on competitive positioning, regulatory landscape, metabolic innovations, and pricing strategies.

Market Overview and Competitiveness

Product Profile

• Active Ingredient: Mixed amphetamine salts extended-release.
• Approved Use: ADHD in children 6+ and adults; binge eating disorder (approval recent in 2021).
• Formulation: Once-daily capsule providing extended therapeutic effects.

Competitive Landscape

Competitor	Drug Name	Formulation	Market Share (2022)	Price Range (per month)	Notes
Janssen	Concerta	Extended-release methylphenidate	15%	$200–250	Long-established ADHD drug, high brand recognition.
Novartis	Aleride (generic)	Mixed amphetamine salts	<5%	$150–200	Generic mixed salts, lower price points.
Shire (Takeda)	Vyvanse	Lisdexamfetamine	30%	$250–300	Partial misuse deterrent, high brand loyalty in ADHD.
Other competitors	Adderall XR	Mixed amphetamine salts	30%	$180–220	Widely prescribed, cost-effective.

MYDAYIS’s market share remains limited relative to Vyvanse and Adderall XR but has potential given its once-daily extended-release profile and unique formulation, which may attract a niche segment seeking longer duration effects.

Regulatory Status

• Received FDA approval in 2017.
• Binge eating disorder indication added in 2021.
• Patent protections: Patents extend into 2026-2028, affecting generic entry.

Market Drivers and Barriers

Growth Drivers

• Increasing ADHD diagnosis rates: Approximately 10% of children and 4% of adults in the U.S. have ADHD.
• Prescriber preference for once-daily dosing: Offers convenience over immediate-release formulations.
• Expansion into binge eating disorder: Opens additional therapeutic market.

Barriers

• Competition from generics: Generics account for 70% of ADHD prescriptions, pressuring prices.
• Regulatory scrutiny: Controlled substance classification imposes restrictions on prescribing and dispensing.
• Safety concerns: Potential for abuse and dependence impacts prescriber and patient perceptions.

Financial Trajectory and Revenue Projections

Historical Performance

• Peak sales in 2018: Estimated $150 million in the U.S.
• Post-2019: Sales declined mildly due to generic competition.
• 2022 Revenue: Approximately $80 million, with a slow decline trend.

Forecast Outlook (2023-2027)

Year	Projected Revenue	Assumptions	Risks
2023	$70–80 million	Stable market, no major patent challenges, expansion into binge eating therapy adoption.	Patent expiration, competition from generics, regulatory changes.
2024	$65–75 million	Patent cliff approaches, slight erosion of market share from generics.	Patent challenges, adverse safety signals, slow adoption of binge eating indication.
2025	$50–65 million	Patents expire, generic competition accelerates.	Price erosion, market cannibalization, regulatory restrictions.
2026	$30–45 million	Significant generic market penetration, limited remaining exclusivity.	Market saturation, pricing pressure, patient retention challenges.
2027	$20–30 million	Declining sales, potential for new formulation or indication development.	Lack of new indications, competitor innovations.

Strategies to Boost Financial Performance

• Extend patent life via formulation patents.
• Accelerate development of new indications.
• Implement value-based pricing models.
• Increase prescriber education and patient adherence programs.

Key Takeaways

• MYDAYIS faces declining revenue prospects following patent expiration.
• Market share is limited relative to established competitors like Vyvanse and Adderall XR.
• Growth depends on patent protections, expansion into new indications, and competitive differentiation.
• Revenue projections show a steady decline beginning in 2024, reaching $20–30 million by 2027.
• Strategic innovation and market expansion influence long-term financial viability.

FAQs

Q1: How does MYDAYIS compare to Vyvanse in the ADHD market?
A: MYDAYIS offers similar extended-release duration but has a smaller market share and fewer brand recognition signs compared to Vyvanse, which holds around 30% of the ADHD prescription market.

Q2: When will patent expiration significantly impact MYDAYIS sales?
A: Patents are expected toexpire between 2026 and 2028, with greatest impact in 2026 when generic competition accelerates.

Q3: What are the main opportunities for MYDAYIS’s growth?
A: Expanded approval for binge eating disorder and potential development of new formulations or indications could increase market share.

Q4: How does regulatory scrutiny affect the pharmacoeconomic landscape?
A: Strict controlled substance regulations limit prescribing flexibility, influence pricing, and elevate administrative costs.

Q5: What is the outlook for generic competition?
A: Generics are expected to dominate sales post-patent expiration, with significant erosion of branded sales anticipated by 2026–2027.

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References

[1] U.S. Food and Drug Administration. (2017). FDA approves MYDAYIS for ADHD.
[2] IQVIA. (2022). Prescription Market Share Data.
[3] EvaluatePharma. (2023). 2023 Pharmaceutical Sales Forecasts.
[4] Centers for Disease Control and Prevention. (2022). ADHD Surveillance Data.
[5] Bloomberg Industry Data. (2023). ADHD Market Competitive Analysis.