Last updated: February 27, 2026
What is NDC 69367-0317?
The National Drug Code (NDC) 69367-0317 is identified as Methylphenidate Hydrochloride Extended-Release (ER) capsules. It is marketed under various brand names, primarily Metadate ER and Concerta. Its primary indications include Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.
Market Overview
Product Profile
- Formulation: Extended-release capsules
- Administration: Oral
- Strengths: Ranges from 10 mg to 60 mg (depending on the specific brand/formulation)
- Pharmacology: Methylphenidate increases dopamine and norepinephrine activity in the brain
Market Size and Trends
- The ADHD medication market is valued at approximately $13 billion globally in 2022, growing at a compound annual growth rate (CAGR) of around 6% (IQVIA, 2022).
- Methylphenidate-based products hold roughly 50–60% of the ADHD market share in the US.
- Extended-release formulations account for nearly 70% of methylphenidate prescriptions due to improved adherence over immediate-release versions.
Competition
Key competitors for NDC 69367-0317 include:
| Brand Name |
Formulation |
Price Range (per unit) |
Market Share (US, 2022) |
| Concerta |
ER tablet |
$15 – $25 |
35% |
| Metadate ER |
ER capsule |
$10 – $20 |
10% |
| Daytrana |
Transdermal patch |
$25 – $35 |
5% |
| Generic methylphenidate ER |
Capsule |
$8 – $18 |
20–30% |
The remaining market is shared among various generic formulations purchased through multiple distributors.
Price Projections
Current Pricing
- Retail prices for branded methylphenidate ER capsules average around $15–$25 per capsule for 20 mg.
- Generic equivalents are priced between $8–$18 per capsule.
- Insurance reimbursement rates favor generics, creating downward pressure on list prices for branded products.
Near-Term Price Outlook (1-2 Years)
- Discounted generic options are expected to dominate the market, maintaining prices in the $8–$15 range.
- Branded product prices will likely remain stable or decline marginally due to increased competition.
- No significant price hikes are forecasted without formulation or patent exclusivity extensions.
Long-Term Price Trends (3-5 Years)
- Patent expirations for certain formulations could trigger further generic penetration, pressuring prices downward.
- Regulatory or policy changes (e.g., price transparency mandates) could influence reimbursement and pricing.
- Market shifts toward digital adherence tools might impact demand and pricing structures for extended-release formulations.
Regulatory and Policy Factors Affecting Prices
- Patent Status: The patent for Concerta expired in 2018, allowing generics to enter the market.
- FDA Approvals: New formulations or delivery mechanisms might influence competitive positioning.
- Pricing Regulations: States exploring drug price transparency reports could pressure manufacturers on pricing strategies.
Market Opportunities and Risks
Opportunities
- Expansion into emerging markets where ADHD treatment is underpenetrated.
- Development of improved delivery systems that enhance compliance or minimize abuse.
- Entry into biosimilar or novel formulations that could command premium pricing.
Risks
- Increased generic competition reducing profit margins.
- Regulatory delays or unfavorable policy changes.
- Market saturation, especially for long-acting methylphenidate products.
Key Takeaways
- NDC 69367-0317 corresponds to methylphenidate ER capsules, competing primarily with branded Concerta and various generics.
- The US ADHD pharmacological market is growing, with extended-release methylphenidate products retaining major market share.
- Price elasticity favors generics in the 8–15 dollar range per capsule; branded products are priced higher but face downward pressure.
- Patent expirations and regulatory trends are set to sustain generic market share dominance.
- Long-term, prices are likely to decline modestly, barring new patent protections or formulations.
Frequently Asked Questions
1. How does patent expiration affect methylphenidate ER prices?
Patent expiration allows generic manufacturers to enter the market, increasing competition and driving prices down.
2. What factors influence insurance reimbursement for NDC 69367-0317?
Reimbursement rates are driven by formulary placement, negotiated drug discounts, and the availability of cheaper generics.
3. Are there any upcoming regulatory changes that could affect prices or market share?
Policy discussions around drug price transparency and generic approval processes could impact future pricing and competition.
4. How do different formulations of methylphenidate compare in market share?
Extended-release capsules dominate due to dosing convenience, capturing approximately 70% of methylphenidate prescriptions.
5. Which markets outside the US have growth potential for this drug?
Emerging markets in Asia, Latin America, and parts of Europe show increasing ADHD medication adoption, representing growth opportunities.
References
- IQVIA. (2022). Pharmaceutical Market Intelligence.
- U.S. Food and Drug Administration. (2022). FDA Drug Approvals and Patent Data.
- Statista. (2022). Global ADHD Medication Market Analysis.
- Medicaid and Medicare Reimbursement Data. (2022).
- FDA Orange Book. (2022). Generic Drug Approvals.
