Introduction to DAYTRANA
DAYTRANA, developed and manufactured by Noven Pharmaceuticals, is the first and only transdermal medication approved by the FDA to treat the symptoms of Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 to 12 years. It contains the active ingredient methylphenidate, delivered through a transdermal patch[1].
Historical Sales Performance
Since its approval, DAYTRANA has shown significant sales growth. By the end of July 2007, Shire's net sales of DAYTRANA exceeded $50 million in the preceding 12 months, triggering a $25 million milestone payment to Noven. In the year leading up to this milestone, DAYTRANA sales to Shire totaled $8.6 million, with $5.9 million recognized in related license revenues. An estimated 700,000 patches were sold during this period[1].
Market Impact and Competition
The ADHD market is highly competitive, with various drug types and formulations available. DAYTRANA's unique transdermal delivery system sets it apart, but it faces competition from other popular ADHD medications like Vyvanse. The launch of Vyvanse, for example, negatively impacted the volume of U.S. prescriptions for DAYTRANA, although DAYTRANA's revenues still increased by 71% year-over-year due to price increases and lower sales deductions[3].
Patent and Generic Landscape
DAYTRANA is protected by three U.S. patents and one international patent family member. However, a generic version of DAYTRANA, also containing methylphenidate, was approved by Mylan (now Viatris) on March 14, 2022. This development is likely to impact DAYTRANA's sales as generic alternatives become more available and potentially more cost-effective for consumers[4].
Current Market Trends
The ADHD market as a whole is experiencing mixed trends. Globally, the market size was estimated at $15.8 billion in 2023 and is projected to reach $24.6 billion by 2032, growing at a CAGR of 5.1% during the forecast period. However, in the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan), the ADHD market is forecast to decline at a negative CAGR of 0.9% from $11.9 billion in 2022 to $10.9 billion in 2032. This decline is driven by patent expiries and the anticipated launch of generic products[2][5].
Sales Projections
Given the approval of generic versions and the competitive landscape, DAYTRANA's sales are likely to face significant challenges. Here are some key points to consider:
- Generic Competition: The approval of a generic version of DAYTRANA in 2022 is expected to erode the market share of the branded product. Generic launches typically lead to a reduction in sales for branded products as payers and consumers opt for the more cost-effective generic alternatives[4][5].
- Market Decline: The overall ADHD market in the 7MM is expected to decline due to patent expiries and generic launches. This broader market trend will likely impact DAYTRANA's sales negatively[5].
- Historical Growth: Despite the challenges, DAYTRANA has historically shown strong growth, particularly in its early years. However, this growth is unlikely to be sustained in the face of increasing generic competition[1].
Future Outlook
The future outlook for DAYTRANA is complex:
- Generic Uptake: The uptake of generic methylphenidate patches is expected to increase, especially as API shortages affecting the ADHD market are resolved by 2027. This will likely result in significant sales erosion for DAYTRANA[5].
- Pricing and Market Share: As generic products become more prevalent, DAYTRANA's market share and pricing power are expected to diminish. This could lead to a decline in revenues and profitability for the product[5].
Key Takeaways
- DAYTRANA is a unique transdermal medication for ADHD but faces intense competition and generic challenges.
- The approval of generic versions of DAYTRANA is expected to significantly impact its sales.
- The broader ADHD market trends, including patent expiries and generic launches, will also affect DAYTRANA's sales projections.
- Despite historical growth, DAYTRANA's future sales are likely to decline due to these factors.
FAQs
Q: What is DAYTRANA, and how is it administered?
A: DAYTRANA is a transdermal patch containing methylphenidate, used to treat ADHD symptoms in children aged 6 to 12 years.
Q: What were the historical sales figures for DAYTRANA?
A: By the end of July 2007, DAYTRANA's net sales exceeded $50 million in the preceding 12 months, triggering a $25 million milestone payment to Noven.
Q: How does the generic approval impact DAYTRANA's sales?
A: The approval of a generic version of DAYTRANA in 2022 is expected to erode the market share and sales of the branded product as consumers opt for the more cost-effective generic alternative.
Q: What are the broader market trends affecting DAYTRANA?
A: The ADHD market in the 7MM is forecast to decline due to patent expiries and generic launches, which will negatively impact DAYTRANA's sales.
Q: When are the patents for DAYTRANA expected to expire?
A: DAYTRANA is protected by three U.S. patents, but specific expiration dates are not provided in the available sources. However, the generic approval indicates that key patents may have expired or are nearing expiration.
Sources
- Outsourcing-Pharma.com - ADHD transdermal patches withdrawn
- GMINsights.com - Attention Deficit Hyperactivity Disorder Market Share, 2024-2032
- SPGlobal.com - Shire Posts 37% Increase in Pharmaceutical Sales During Q1
- DrugPatentWatch.com - When do the patents on DAYTRANA expire, and when will generic versions be available?
- ClinicalTrialsArena.com - 7MM ADHD market forecast to decline by $1bn between 2022 and 2032
Last updated: 2024-12-31
