MYDAYIS Drug Patent Profile

Which patents cover Mydayis, 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-eight 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 sixteen 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

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	022063-003	Jun 20, 2017
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	022063-003	Jun 20, 2017

International Patents for MYDAYIS

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

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	200500530	ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ АМФЕТАМИНА И/ИЛИ ЕГО СОЛЕЙ (ВАРИАНТЫ) И СПОСОБ ЛЕЧЕНИЯ НАРУШЕНИЙ ТИПА ГИПЕРАКТИВНОСТИ ПРИ ДЕФИЦИТЕ ВНИМАНИЯ С ЕЕ ИСПОЛЬЗОВАНИЕМ (ВАРИАНТЫ)
Eurasian Patent Organization	018082	ПРЕПАРАТИВНАЯ ФОРМА ДЛЯ ЛЕЧЕНИЯ ГИПЕРАКТИВНОСТИ ПРИ ДЕФИЦИТЕ ВНИМАНИЯ, ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ НА ЕЕ ОСНОВЕ И СПОСОБ ЛЕЧЕНИЯ ГИПЕРАКТИВНОСТИ ПРИ ДЕФИЦИТЕ ВНИМАНИЯ (PREPARATIVE FORMULATION FOR TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER, PHARMACEUTICAL COMPOSITION BASED THEREON AND METHOD FOR TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER)
Croatia	P20050356	SUSTAINED RELEASED DELIVERY OF AMPHETAMINE SALTS
Denmark	1542660
South Korea	20050084589	SUSTAINED RELEASE DELIVERY OF AMPHETAMINE SALTS

MYDAYIS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Mydayis

Introduction

Mydayis, a once-daily treatment for Attention Deficit Hyperactivity Disorder (ADHD), was approved by the U.S. Food and Drug Administration (FDA) in June 2017. Developed by Shire plc, Mydayis represents a significant advancement in ADHD treatment, particularly for patients seeking a long-lasting medication. Here, we delve into the market dynamics and financial trajectory of Mydayis.

Market Need and Unmet Needs

ADHD is a prevalent neurodevelopmental disorder affecting approximately 4.4% of adults in the U.S., with around 10.5 million adults estimated to have ADHD. Many patients with ADHD face challenges with existing medications, such as the need to augment their morning medication due to its short duration of action. A survey revealed that 67% of patients augment their morning medication because it stops working, and 42% have to plan their day around their medication wearing off[3].

Unique Selling Proposition

Mydayis stands out due to its innovative 3-bead technology, which releases amphetamine in the stomach and at various points in the small intestine over several hours. This technology allows the medication to be effective for up to 16 hours, beginning at 2 or 4 hours post-dose. This extended duration addresses a significant unmet need for patients who require consistent symptom control throughout the day[1][3].

Clinical Efficacy

The FDA approval of Mydayis was based on results from 16 clinical studies involving more than 1,600 subjects, including adolescents and adults. These studies demonstrated that Mydayis significantly improved ADHD symptoms as measured by the ADHD Rating Scale (ADHD-RS-IV) and the Permanent Product Measure of Performance (PERMP). The medication showed efficacy in both short-term and long-term studies, with improvements lasting up to 16 hours post-dose[1][5].

Safety and Tolerability

Safety and tolerability assessments were conducted in both short-term and long-term studies. Common adverse events reported included insomnia, dry mouth, and decreased weight. Insomnia typically occurred between days 4 and 9 and often resolved without a dose change. The safety profile of Mydayis is similar to other long-acting amphetamine compounds[3][5].

Market Launch and Availability

Mydayis was commercially available in the United States starting in the third quarter of 2017. It is available in four dosages: 12.5 mg, 25 mg, 37.5 mg, and 50 mg. This range allows clinicians to tailor the treatment to individual patient needs[1][5].

Financial Impact

The introduction of Mydayis was part of Shire's broader strategy to expand its ADHD treatment portfolio. While specific financial data for Mydayis alone is not readily available, the drug's approval and market entry contributed to Shire's overall revenue growth. Shire's commitment to ADHD treatments has been a significant factor in its financial performance, reflecting the company's long-term investment in this therapeutic area[1].

Competitive Landscape

The ADHD market is competitive, with several established medications like Adderall XR. However, Mydayis differentiates itself through its extended duration of action and unique delivery mechanism. This differentiation can attract patients and healthcare providers seeking a once-daily option that provides consistent symptom control throughout the day[3].

Patient Adherence

Studies have shown that adults managing their ADHD with multiple pills are less likely to adhere to their regimen. Mydayis, as a once-daily medication, can improve patient adherence by simplifying the treatment regimen and reducing the need for multiple doses throughout the day[3].

Expert Insights

According to Manisha Madhoo, MD, Vice President of Global Medical Affairs, Neuroscience at Shire, "Mydayis is significantly clinically superior to placebo in the ADHD Rating Scale and Clinical Global Impressions-Improvement." This underscores the clinical value of Mydayis in treating ADHD[5].

Regulatory Approval and Safety Monitoring

The FDA approval of Mydayis included an assessment of cardiovascular safety, which is crucial for long-acting amphetamine products. The top adverse events reported were similar to those of other long-acting amphetamines, indicating that Mydayis aligns with the safety profile of similar medications[5].

Conclusion

Mydayis has carved out a niche in the ADHD treatment market by offering a once-daily option with extended efficacy. Its unique delivery mechanism and clinical efficacy make it an attractive choice for patients and healthcare providers. While specific financial data for Mydayis is not detailed, its contribution to Shire's overall revenue and the company's commitment to ADHD treatments highlight its importance in the market.

Key Takeaways

• Extended Efficacy: Mydayis provides symptom control for up to 16 hours, addressing a significant unmet need for long-lasting ADHD medication.
• Unique Delivery Mechanism: The 3-bead technology ensures amphetamine release at various points in the gastrointestinal tract, maintaining efficacy throughout the day.
• Clinical Efficacy: Mydayis has demonstrated significant improvements in ADHD symptoms in both short-term and long-term studies.
• Safety Profile: Common adverse events are similar to those of other long-acting amphetamine compounds, with insomnia, dry mouth, and decreased weight being notable.
• Market Impact: Mydayis has contributed to Shire's revenue growth and expanded the company's ADHD treatment portfolio.

FAQs

Q: What is the unique feature of Mydayis compared to other ADHD medications? A: Mydayis features a 3-bead technology that releases amphetamine at different points in the gastrointestinal tract, providing efficacy for up to 16 hours.

Q: Who is Mydayis approved for? A: Mydayis is approved for patients 13 years and older with ADHD.

Q: What are the common adverse events associated with Mydayis? A: Common adverse events include insomnia, dry mouth, and decreased weight.

Q: How does Mydayis improve patient adherence? A: As a once-daily medication, Mydayis simplifies the treatment regimen, reducing the need for multiple doses and improving patient adherence.

Q: What is the significance of Mydayis in the ADHD treatment market? A: Mydayis addresses the unmet need for a long-lasting ADHD medication, offering a unique and clinically effective treatment option that enhances patient care and convenience.

Sources

1. U.S. FDA Approves Mydayis™ (mixed salts of a single-entity amphetamine product) – A New Once-Daily Option for ADHD Symptom Control in Patients 13 Years and Older. Shire plc.
2. Mallinckrodt plc Reports Second Quarter 2024 Financial Results and Updates 2024 Guidance. Mallinckrodt plc.
3. Shire Presents Data on Efficacy of Mydayis, Unmet Need for Adults with ADHD. The American Journal of Managed Care.
4. Mallinckrodt plc Reports Fourth Quarter and Fiscal Year 2023 Financial Results. Mallinckrodt plc.
5. Mydayis improves ADHD, functioning in adults. Healio.