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:	25
Clinical Trials:	15
Patent Applications:	4,496
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
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
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-004	Apr 6, 2006	AB	RX	Yes	Yes			Y
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-003	Apr 6, 2006	AB	RX	Yes	No			Y

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

International Patents for DAYTRANA

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

Country	Patent Number	Title	Estimated Expiration
Colombia	4970785	COMPOSICIONES Y METODOS PARA TRATAR CON METILFENIDATO EL DEFICIT DE LA ATENCION Y EL DEFICIT DE LA ATENCION CON HIPERACTIVIDAD
Hong Kong	1006155
Norway	962833
Australia	3284789
Slovenia	20360	Sredstva in metode za zdravljenje motenj v zvezi z neuravnovešenostjo ter hiperaktivnih motenj v zvezi z neuravnovešenostjo s pomočjo metilfenidata (COMPOSITIONS AND METHODS FOR TREATMENT OF ATTENTION DEFICIT DISORDER AND ATTENTION DEFICIT/HYPERACTIVITY DISORDER WITH METHYLPHENIDATE)

DAYTRANA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for DAYTRANA

Introduction to DAYTRANA

DAYTRANA (methylphenidate transdermal system) is a prescription medication developed and manufactured by Noven Pharmaceuticals, and it is the first and only transdermal medication approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17 years[1][3][5].

Market Position and Unique Selling Points

First and Only Transdermal Medication

DAYTRANA holds a unique position in the ADHD treatment market as the only transdermal patch available. This distinguishes it from other ADHD medications like Adderall and Ritalin LA, which are administered orally[1][2].

Dosage and Administration

The patch is available in four dosage strengths and is designed to be worn for 9 hours, providing a controlled release of methylphenidate. This can be an advantage for parents and caregivers who may find it easier to manage compared to oral medications[1].

Clinical Efficacy and Approval

Clinical Trials and Approval

The efficacy of DAYTRANA was established through several controlled clinical trials in children and adolescents. These trials demonstrated its effectiveness in reducing the symptoms of ADHD, making it a valuable treatment option[3].

Regulatory Oversight

DAYTRANA is regulated by the FDA, and its use is subject to careful supervision, especially regarding potential abuse and dependence. The FDA has also issued warnings about potential side effects, including permanent skin color changes[4].

Side Effects and Safety Concerns

Common Side Effects

Common side effects of DAYTRANA include decreased appetite, trouble sleeping, nausea, vomiting, weight loss, and skin problems at the application site. These side effects vary slightly between children aged 6-12 and those aged 13-17[1].

Serious Side Effects

More serious side effects can include permanent skin color changes, increased blood pressure and heart rate, and psychological symptoms such as aggressive behavior and irritability[4].

Financial Aspects

Cost Factors

The cost of DAYTRANA can vary significantly based on several factors, including the dosage, insurance coverage, and the pharmacy used. Without insurance, the cost can be substantially higher, and patients may need to explore savings programs or coupons to reduce the expense[2].

Insurance and Savings Programs

Patients with insurance may need prior authorization for DAYTRANA, and the cost can be mitigated through savings programs or by obtaining a 90-day supply of the medication. Resources like Optum Perks can also help in estimating and reducing costs[2].

Comparison with Other ADHD Medications

The cost of DAYTRANA is influenced by its unique form as a transdermal patch, which can differ from the costs of oral medications like Adderall and Ritalin LA. Factors such as insurance coverage, treatment duration, and available coupons also play a role in the overall cost comparison[2].

Market Performance and Sales

Historical Sales Data

DAYTRANA was originally licensed to Shire plc, which reported net sales of $34.7 million for the first half of 2010. After Noven Pharmaceuticals acquired the global rights to DAYTRANA in 2010, the product continued to be marketed and sold through Noven Therapeutics[5].

Prescription Trends

In 2014, approximately 109,000 patients received prescriptions for DAYTRANA, which was a decrease from the 136,500 patients in 2010. This trend indicates fluctuations in the market demand for the medication[4].

Marketing and Distribution

Acquisition and Marketing

Noven Pharmaceuticals completed the acquisition of DAYTRANA from Shire plc in 2010 and has since marketed and sold the product through its specialty pharmaceuticals unit, Noven Therapeutics. This acquisition has allowed Noven to actively promote DAYTRANA and increase awareness among patients, physicians, and caregivers[5].

Distribution Channels

DAYTRANA is distributed through various pharmacies, and its availability has not been interrupted by the acquisition or transfer of the product to Noven. This ensures consistent access for patients who rely on this medication[5].

Future Outlook

Market Competition

The ADHD treatment market is competitive, with several oral medications available. However, DAYTRANA's unique delivery method and established efficacy make it a significant player in this market. As awareness and promotion efforts continue, DAYTRANA is likely to maintain its position as a valuable treatment option[1][2].

Financial Projections

Given the fluctuations in prescription trends and the competitive nature of the ADHD treatment market, financial projections for DAYTRANA would need to consider these factors. Efforts to increase awareness and improve cost savings programs could help stabilize or increase sales[4][5].

Key Takeaways

• Unique Delivery Method: DAYTRANA is the first and only transdermal medication for ADHD.
• Clinical Efficacy: Proven through controlled clinical trials in children and adolescents.
• Cost Factors: Varies based on dosage, insurance, and pharmacy.
• Side Effects: Includes common side effects like decreased appetite and serious side effects like permanent skin color changes.
• Market Performance: Historical sales data shows fluctuations, with ongoing marketing efforts by Noven Therapeutics.
• Future Outlook: Competitive market position with potential for increased awareness and sales.

FAQs

Q: What is DAYTRANA used for?

A: DAYTRANA is used to treat Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17 years.

Q: How is DAYTRANA administered?

A: DAYTRANA is administered via a transdermal patch that is worn for 9 hours.

Q: What are the common side effects of DAYTRANA?

A: Common side effects include decreased appetite, trouble sleeping, nausea, vomiting, weight loss, and skin problems at the application site.

Q: Can DAYTRANA cause serious side effects?

A: Yes, serious side effects can include permanent skin color changes, increased blood pressure and heart rate, and psychological symptoms.

Q: How much does DAYTRANA cost without insurance?

A: The cost without insurance can be higher and varies based on dosage, pharmacy, and available savings programs.

Sources

1. Noven Pharmaceuticals - DAYTRANA
2. Healthline - Cost and Daytrana: Financial Assistance Options, Savings, More
3. FDA - DAYTRANA® (methylphenidate transdermal system)
4. FDA - FDA reporting permanent skin color changes associated with use of Daytrana
5. Noven Pharmaceuticals - Noven Completes Acquisition of DAYTRANA® Methylphenidate Transdermal System (CII) from Shire