DAYTRANA Drug Patent Profile

Which patents cover Daytrana, and when can generic versions of Daytrana launch?

Daytrana is a drug marketed by Noven Pharms Inc and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has one patent family member in one country.

The generic ingredient in DAYTRANA is methylphenidate. There are thirty-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the methylphenidate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Daytrana

A generic version of DAYTRANA was approved as methylphenidate by MYLAN TECH VIATRIS on March 14^th, 2022.

Summary for DAYTRANA

International Patents:	1
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	15
Patent Applications:	5,700
Drug Prices:	Drug price information for DAYTRANA
Drug Sales Revenues:	Drug sales revenues for DAYTRANA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DAYTRANA
What excipients (inactive ingredients) are in DAYTRANA?	DAYTRANA excipients list
DailyMed Link:	DAYTRANA at DailyMed

See drug prices for DAYTRANA

See drug sales revenues for DAYTRANA

Recent Clinical Trials for DAYTRANA

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 2/Phase 3
M.D. Anderson Cancer Center	Phase 2/Phase 3
Matthew O'Brien	Phase 4

See all DAYTRANA clinical trials

Pharmacology for DAYTRANA

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

Paragraph IV (Patent) Challenges for DAYTRANA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DAYTRANA	Transdermal System	methylphenidate	10 mg/9 hrs 15 mg/9 hrs 20 mg/9 hrs 30 mg/9 hrs	021514	1	2011-04-13

US Patents and Regulatory Information for DAYTRANA

DAYTRANA 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
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-001	Apr 6, 2006	AB	RX	Yes	No	9,668,981
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-003	Apr 6, 2006	AB	RX	Yes	No	9,668,981
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-002	Apr 6, 2006	AB	RX	Yes	No	9,668,981

Expired US Patents for DAYTRANA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-004	Apr 6, 2006	5,958,446
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-004	Apr 6, 2006	8,632,802
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-003	Apr 6, 2006	5,958,446

International Patents for DAYTRANA

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

Country	Patent Number	Title	Estimated Expiration
Austria	235898
European Patent Office	0591432	SYSTEME D'APPORT DE MEDICAMENTS FONDE SUR UN PARAMETRE DE SOLUBILITE ET PROCEDE MODIFIANT LA CONCENTRATION DE SATURATION D'UN MEDICAMENT (SOLUBILITY PARAMETER BASED DRUG DELIVERY SYSTEM AND METHOD FOR ALTERING DRUG SATURATION CONCENTRATION)
Taiwan	I244396

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Daytrana

Last updated: July 27, 2025

Introduction

Daytrana, a transdermal patch formulation of methylphenidate, represents a significant innovation within the ADHD treatment landscape. Approved by the U.S. Food and Drug Administration (FDA) in 2006, it offers an alternative to oral stimulants with potential benefits in compliance, onset of action, and reduced abuse potential. This analysis explores the market dynamics influencing Daytrana's trajectory, examines its financial prospects, and evaluates key factors shaping its future within the competitive ADHD therapeutics sector.

Market Overview and Driver Dynamics

ADHD Market Growth and Demographics

Attention Deficit Hyperactivity Disorder (ADHD) affects approximately 8-10% of children and 4-5% of adults worldwide, with prevalence rates steadily rising due to increased awareness and diagnostic accessibility[1]. The dominant therapeutic class comprises stimulant medications, predominantly methylphenidate and amphetamines, which account for a substantial portion of the ADHD drug market valuation.

The global ADHD medication market was valued at around $12 billion in 2021 and is projected to grow at a Compound Annual Growth Rate (CAGR) of approximately 4-6% through 2028[2]. Factors contributing to this growth include expanding diagnostic criteria, increased awareness, and a rising inclination toward pharmacological management over behavioral interventions.

Product Positioning of Daytrana

Daytrana's unique delivery mechanism positions it as an alternative for specific patient subsets, especially those who experience difficulties swallowing pills, require controlled onset and offset profiles, or are at increased risk of misuse with oral formulations. Its patch technology ensures a steady release of methylphenidate over a 9-hour period, offering predictable pharmacokinetics that can improve adherence.

However, retail barriers—such as patch visibility concerns, variable absorption rates, and less familiarity among clinicians—have limited its widespread adoption relative to oral formulations like Ritalin or Concerta.

Market Challenges and Competitive Landscape

The ADHD therapeutic landscape is intensely competitive, with several high-revenue drugs, including Concerta, Adderall XR, Vyvanse, and generics, dominating the market. Many of these have established physician and patient familiarity, extensive insurance coverage, and significant marketing presence.

Daytrana faces challenges:

• Limited Market Penetration: Lower prescribing rates compared to oral pills.
• Pricing and Reimbursement: Higher per-unit costs and reimbursement complexities for patches.
• Patient Preferences: Many patients and caregivers prefer pills for ease of use.

Nonetheless, Daytrana benefits from a niche appeal, particularly among patients seeking non-oral options or with contraindications to oral stimulants.

Financial Trajectory and Economic Considerations

Revenue Performance

Since its launch, Daytrana has experienced tepid sales growth, partly attributable to limited market adoption. According to IQVIA data, its annual sales peaked modestly, with estimates around $20 million globally in recent years[3]. The drug's niche positioning limits its revenue potential without significant market expansion strategies.

Research and Development Investment

GlaxoSmithKline (GSK), the original developer of Daytrana, has scaled back direct marketing efforts, aligning with the broader trend of increased reliance on generics in ADHD. The cost of continued R&D for reformulations or new patch delivery systems remains high, with uncertain returns absent market penetration.

Future Revenue Outlook

The future financial trajectory depends on:

• Market Expansion: Adoption in adult ADHD, which accounts for approximately 50% of cases, remains limited but growing. Expanding indications or formulations tailored for adults could boost sales.
• Pipeline Developments: Innovations in patch technology or combination therapies could rejuvenate interest.
• Competitive Strategies: Strategic collaborations or licensing agreements might facilitate wider distribution channels.

Pricing Dynamics and Reimbursement

Price benchmarks set by competitors influence Daytrana's market share. Given its premium positioning, reimbursement hurdles can restrict access, impacting revenue potential. Payers’ increasing preference for cost-effective generics pressures the pricing of branded patch formulations.

Impact of Patent and Patent Expirations

While Daytrana's patent protection has expired, the company holds secondary patents concerning specific formulations to extend market exclusivity. However, generic competitors could significantly erode its sales unless it secures new patent protections or innovates further.

Regulatory and Legal Factors

The regulatory landscape is pivotal. Post-approval, the FDA’s strict oversight can influence formulation modifications or new indications. Litigation risk regarding patent infringement or safety concerns (e.g., skin reactions) also factors into the financial outlook.

Market Trends and Future Opportunities

Growing Adult ADHD Market

The increasing diagnosis of adult ADHD presents a lucrative expansion opportunity for Daytrana, assuming formulation adjustments or educational campaigns targeting clinicians.

Innovative Delivery Systems

Research into multi-layered patches, reduced skin irritation, and improved adhesion can enhance patient acceptability, potentially expanding its user base.

Positioning within a Digital Health Ecosystem

Integration with digital therapeutics and adherence tracking could provide value-added functionalities, differentiating Daytrana in a crowded market.

Conclusion

Daytrana’s market dynamics are shaped by its niche positioning against a backdrop of robust oral stimulant competition, evolving patient preferences, and reimbursement intricacies. Financially, the drug remains a modest contributor within the ADHD market, with growth contingent upon strategic market expansion and technological innovation. Its future hinges on leveraging higher-demand segments such as adult ADHD, improving delivery technology, and navigating reimbursement landscapes.

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Key Takeaways

• Market Niche: Daytrana serves a niche market, primarily for patients seeking non-oral methylphenidate options, limiting significant revenue growth without market expansion.
• Growth Drivers: Increasing adult ADHD diagnoses and innovations in patch technology are critical drivers for future adoption.
• Competitive Pressure: Competing with well-established oral formulations and generic versions constrains pricing power and market penetration.
• Revenue Prospects: Limited recent sales suggest potential for growth if strategies focus on adult populations and technological improvements.
• Strategic Focus: Innovating delivery systems, engaging with payers, and exploring combination therapies are essential to enhance Daytrana’s financial trajectory.

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FAQs

1. How does Daytrana compare to other ADHD medications in terms of efficacy?
Daytrana provides comparable efficacy to oral methylphenidate formulations in managing ADHD symptoms. Its pharmacokinetic profile offers steady plasma levels, which can improve symptom control and reduce side effects for some patients[4].

2. What are the main barriers to wider adoption of Daytrana?
Main barriers include limited clinician familiarity, higher cost relative to generics, insurance reimbursement challenges, and patient preference for oral pills. Skin irritation and patch visibility issues also impact adherence.

3. Are there any recent developments or pipeline products related to Daytrana?
While no major reformulations or new indications are currently announced, ongoing research explores advanced transdermal systems and combination patches that could broaden its appeal.

4. What factors could stimulate increased revenue for Daytrana?
Increased acceptance among adult ADHD patients, technological improvements enhancing comfort and efficacy, effective marketing, and favorable reimbursement policies could boost sales.

5. How does patent expiration affect Daytrana's market prospects?
Patent expiration opens the market to generics, which can significantly reduce pricing and sales volume unless the manufacturer secures new patents or develops innovative delivery systems to maintain market exclusivity.

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Sources:
[1] Faraone, S. V., et al. (2022). The World Federation of ADHD Guidelines. Journal of Attention Disorders.
[2] Grand View Research. (2022). ADHD Market Size & Trends.
[3] IQVIA. (2022). U.S. ADHD Market Data Reports.
[4] Biederman, J., et al. (2008). Pharmacokinetic Profiles and Clinical Efficacy of Daytrana. Pediatric Drugs.