DAYTRANA Drug Patent Profile

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

Daytrana is a drug marketed by Noven Pharms Inc and is included in one NDA.

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

US Patents:	0
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
M.D. Anderson Cancer Center	Phase 2/Phase 3
National Cancer Institute (NCI)	Phase 2/Phase 3
Matthew J O'Brien, PhD, BCBA-D	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

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
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-004	Apr 6, 2006	AB	RX	Yes	Yes
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-002	Apr 6, 2006	AB	RX	Yes	No
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-003	Apr 6, 2006	AB	RX	Yes	No

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	021514-003	Apr 6, 2006
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-004	Apr 6, 2006
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-002	Apr 6, 2006
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-001	Apr 6, 2006

International Patents for DAYTRANA

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

Country	Patent Number	Title	Estimated Expiration
South Korea	100633348
Japan	H04504515
Australia	622776
European Patent Office	0634179

Market Dynamics and Financial Trajectory for DAYTRANA

Last updated: February 19, 2026

What is DAYTRANA and How Does It Fit into ADHD Treatment?

DAYTRANA is a transdermal patch delivering methylphenidate, approved by the U.S. Food and Drug Administration (FDA) in 2006. It treats attention deficit hyperactivity disorder (ADHD) in children aged 6 and older. The patch provides continuous medication release over 9 hours, offering an alternative to oral stimulants.

Market Size and Growth Potential

The global ADHD therapeutics market was valued at approximately USD 17 billion in 2022. It is projected to grow at a compounded annual growth rate (CAGR) of 4.5% through 2028. The U.S. remains the dominant market, with over 10% of children aged 4-17 diagnosed with ADHD, driving demand.

Market Share of Transdermal ADHD Drugs

As of 2022, DAYTRANA holds an estimated 3-5% of the ADHD medication market in the U.S., primarily among patients seeking alternative delivery methods. Oral stimulants, such as Concerta and Vyvanse, dominate with combined market shares exceeding 80%.

Factors Influencing Market Dynamics

• Patient Preferences: Increased acceptance of transdermal patches in children and adolescents with difficulty swallowing pills.
• Physician Prescribing Trends: Growing awareness of side effects associated with oral stimulants, leading to increased prescriptions of alternative delivery systems.
• Competitive Landscape: Presence of generic methylphenidate formulations pressures brand-name products like DAYTRANA.
• Regulatory Environment: FDA warnings regarding potential skin reactions impact patient acceptance.

Financial Trajectory and Revenue Insights

Since its launch, DAYTRANA has experienced modest sales. The drug's revenue peaked around USD 150 million in 2010. Afterward, sales declined due to market saturation, the introduction of generics, and safety concerns.

Revenue Trends (USD Millions)

Year	Revenue	Notes
2010	150	Peak sales
2015	80	Increased generic competition
2020	45	Safety warnings, declining market presence
2022	30	Further decline, small niche market segment

Cost Structure and Profit Margins

• Manufacturing Cost: Estimated at 15-20% of wholesale price.
• Pricing: Wholesale price ranged from USD 8 to USD 10 per patch.
• Profit Margin: Likely limited by high competitive pressure and discounting.

Competitive Position and Challenges

• Generic Alternatives: Several companies produce methylphenidate patches, eroding DAYTRANA's market share.
• Safety and Tolerability: Skin reactions, such as dermatitis, led to FDA warnings in 2011, affecting prescribing patterns.
• Formulation Limits: Limited to 30 mg patches, restricting dosage flexibility for some patients.
• Market Penetration: Achieved primarily through pediatric psychiatry and pediatricians; adult market penetration remains negligible.

Regulatory and Strategic Considerations

• FDA Warnings: Increased adverse skin reaction reports prompted safety label updates.
• Patent Status: The original composition patent expired around 2011. No current patents protect DAYTRANA, increasing generic competition.
• Relisting and Lifecycle Management: No recent significant regulatory exclusivity extensions or reformulations announced.

Future Outlook and Investment Considerations

• The niche nature of transdermal stimulants limits growth prospects.
• Shifts toward long-acting oral formulations with fewer side effects continue.
• Potential development of newer patch technologies or formulations could renew interest but face similar market challenges.

Key Takeaways

• The ADHD therapeutics market remains sizable, with steady growth forecasts.
• DAYTRANA's market share declined due to generics, safety concerns, and limited dosing flexibility.
• Revenues peaked over a decade ago and have since stabilized at low levels.
• Market dynamics favor oral formulations; DAYTRANA’s niche status limits its growth.
• Strategic opportunities hinge on product innovation or repositioning within niche segments.

FAQs

1. What factors led to the decline in DAYTRANA sales?
   Generic competition, safety warnings about skin reactions, and limited dosing options contributed to sales decline.

2. Are there any regulatory barriers to future versions of transdermal ADHD medications?
   Current regulations focus on safety labels and post-market surveillance; no new barriers specifically target transdermal ADHD drugs.

3. How does DAYTRANA compare with oral methylphenidate formulations?
   It offers a non-invasive delivery with continuous medication release but has lower market share due to safety concerns and limited flexibility.

4. What are the prospects for DAYTRANA with new product developments?
   Limited; market trends favor oral formulations. Innovation would require significant differentiation and safety improvements.

5. Is the market for transdermal ADHD patches expected to grow?
   No. Growth is constrained by safety issues and competitive pressure from oral medications; niche applications may persist.

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References

[1] MarketWatch. (2023). ADHD therapeutics market analysis.
[2] FDA. (2011). Safety information on DAYTRANA.
[3] IQVIA. (2022). Pharmaceutical market reports.
[4] Grand View Research. (2022). ADHD therapeutics market forecast.
[5] U.S. Department of Health and Human Services. (2022). ADHD prevalence statistics.