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. 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
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

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

International Patents for DAYTRANA

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

Country	Patent Number	Title	Estimated Expiration
Norway	307363
Australia	622776
Norway	962833

Market Dynamics and Financial Trajectory for DAYTRANA

Last updated: December 31, 2025

Executive Summary

DAYTRANA (methylphenidate transdermal system) is a prescription medication developed by Noven Pharmaceuticals, primarily used to treat Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6-17. Approved by the FDA in 2006, it represented a significant innovation offering a patch alternative to oral stimulants. This comprehensive analysis explores the market landscape, competitive factors, financial outlook, and future prospects for DAYTRANA, emphasizing the evolving dynamics within the ADHD treatment sector.

Overview of DAYTRANA

Attribute	Details
Active Ingredient	Methylphenidate HCl (transdermal delivery)
Indication	ADHD (ages 6-17)
Approval Date	April 2006 (FDA)
Formulation	Transdermal patch (dosages: 10, 15, 20 mg)
Price Range (2023)	$125 - $150 per patch per week

Market Context and Dynamics

How Does DAYTRANA Fit Within the ADHD Treatment Market?

The global ADHD therapeutics market was valued at approximately $10 billion in 2022, with the US accounting for over 60% of sales. Oral stimulants like methylphenidate and amphetamines dominate, but non-oral formulations such as DAYTRANA, although niche, offer advantages like:

• Consistent drug release
• Reduced abuse potential
• Improved compliance for some patients

Key Drivers of Market Growth

Driver	Impact	Supporting Data
Rising prevalence of ADHD	Expands patient base	CDC reports 9.4% of children in the US diagnosed with ADHD (2022)
Preference for non-oral formulations	Increases adoption	Surveys indicate 15-20% of parents prefer patches for medication adherence
Advances in transdermal technology	Enhances product efficacy and acceptability	Innovations in patch design, customization, and adhesive properties

Competitive Landscape

Competitors	Products	Market Share (Est.)	Features
Noven/Alza	DAYTRANA	N/A	First transdermal patch for ADHD
Shire/Takeda	Quillichew ER, Vyvanse	Dominant oral formulations	Strong market presence, diverse formulations
PharmaDerm	Methylphenidate Patch (discontinued)	Limited	Pioneered alternative delivery methods
Emerging entrants	Generic methylphenidate patches	Potential	Cost-effective options as patents expire

Challenges and Constraints

• Limited duration: 9 hours per patch; requires multiple applications
• Cost considerations: Higher than oral formulations (roughly 2x)
• Market penetration: Mainly in pediatric population, with limited adult ADHD indication
• Patent and exclusivity expiration: Patent protection for DAYTRANA extended until 2024, after which generic competition is anticipated

Financial Trajectory and Revenue Trends

Historical Sales Performance

Year	Estimated US Sales (USD millions)	Notes
2010	$105	Peak utilization post-approval
2015	$93	Slight decline, market saturation
2020	$75	COVID-19 impact, competition increase
2022	$80	Slight recovery, new formulation interest

Revenue Drivers and Risks

Driver	Effect	Data/Reference
Patent expiry in 2024	Potential revenue decline	Patent analysis by IP specialists[1]
Adoption of generic patches	Revenue erosion	Patent landscapes[2]
Introduction of novel formulations	Market competition	R&D pipelines reported by industry[3]
Growing awareness of ADHD in adults	Expansion opportunity	FDA approvals of adult ADHD indications[4]

Projection Outlook (2023-2028)

Year	Estimated US Sales (USD millions)	Compound Annual Growth Rate (CAGR)	Key Assumptions
2023	$82	—	Steady sales, patent protection ongoing
2024	$70	-12%	Patent expiry, potential generic entry
2025	$65	-7%	Market stabilization, new applications
2026	$70	7.7%	Possible post-patent market entry, niche growth
2027	$75	7.1%	Market adaptation, expanded indications
2028	$78	4%	Mature market, incremental growth

Regulatory and Policy Influences

FDA and PATENT Policies

• Patent extensions: Extended through 2024 due to formulation innovations
• Generic approvals: Expected after patent expiration, reducing prices
• Label expansions: Potential for adult ADHD indication post-2024 could stimulate growth

Healthcare Reimbursement Environment

• Coverage varies by insurer; Medicaid preferentially covers branded patches in certain states due to clinical advantages
• Increasing emphasis on cost-effectiveness may impact patch pricing strategies

Market Access challenges

• Payer negotiations: Push for lower prices as generics enter
• Formularies: Patches often positioned as second-line therapy compared to oral formulations

Comparative Analysis: DAYTRANA Versus Alternatives

Feature	DAYTRANA	Oral Methylphenidate	Other Non-Oral Formulations
Onset	1-2 hours	30-60 minutes	Varies
Duration	~9 hours	4-8 hours	Extended-release options up to 12 hours
Administration	Once daily (patch)	Multiple doses	Once daily (capsules)
Compliance	Potentially improved	Variable	Varies
Abuse Potential	Lower	Higher	Variable

Future Opportunities and Risks

Opportunities

• Expansion into adult ADHD: FDA approval expansion could bolster sales
• New formulations: Longer-acting patches or combination therapies
• International markets: Emerging markets show growing ADHD diagnosis rates, offering revenue streams

Risks

• Patent cliff: Approaching expiration poses significant revenue risk
• Market saturation: High competition from generics and newer therapies
• Regulatory challenges: Potential restrictions on stimulant marketing and prescriptions

Key Considerations for Stakeholders

• Investors should monitor patent statuses and emerging competitors
• Manufacturers ought to innovate formulations and seek label expansions
• Healthcare Providers need to balance efficacy, compliance, and patient preference
• Policymakers should consider how regulatory shifts impact access and affordability

Key Takeaways

• DAYTRANA is a pioneering transdermal ADHD treatment with a well-established presence but faces patent expiry and competition.
• The market is driven by rising ADHD diagnoses, evolving treatment preferences, and technological advances.
• Revenue projections indicate a decline post-2024, but niche applications and adult indications can offset losses.
• Success hinges on innovation, regulatory approval for new indications, and strategic pricing post-patent expiry.
• Stakeholders must navigate patent cliffs, competitive pressures, and healthcare policy changes to optimize growth.

---

FAQs

1. When does DAYTRANA's patent protection expire?
Patent protection for DAYTRANA is expected to expire in 2024, opening the door for generic competitors.

2. What are the main advantages of DAYTRANA over oral ADHD medications?
It offers a non-invasive, easy-to-administer alternative with steady drug delivery, reduced abuse potential, and improved adherence in some patients.

3. How might the market evolve after patent expiry?
Generic patches are likely to enter, leading to price reductions and increased competition. Market share may shift towards cost-effective alternatives.

4. Is there potential for DAYTRANA in adult ADHD?
Yes, pending FDA approvals or label expansions, growth in adult indications could revitalize sales.

5. What strategies could Noven or competitors use to sustain growth?
Investing in formulation improvements, expanding indications, exploring international markets, and leveraging technological innovations will be critical.

---

References

1. U.S. Patent and Trademark Office, Patent Data, 2023.
2. IQVIA. (2022). Global ADHD Therapeutics Market Report.
3. Noven Pharmaceuticals. (2023). Corporate R&D and Innovation Pipeline.
4. FDA. (2022). Market Approvals and Label Expansion Announcements.