Last updated: February 16, 2026
What Is the Market Status and Price Projection for NDC 00168-0346?
NDC 00168-0346 is a formulation of methylphenidate hydrochloride, typically used for ADHD management. Its market landscape and pricing depend on approval status, manufacturing, competition, and regulatory factors.
Regulatory and Market Status
- FDA Approval: The drug has received FDA approval, with the latest approval date listed as 2018-05-23.
- Indications: Primarily prescribed for ADHD in children and adults.
- Manufacturer: Lilly USA, LLC, filed the patent and marketed the original branded version.
- Market Presence: Generic versions entered the U.S. market around 2019, intensifying competition.
- Patent Expiry: The original patent expired in 2018, enabling generics.
Current Market Dynamics
- Market Size: The ADHD medication market in the U.S. was valued at approximately $12.8 billion in 2022, with methylphenidate products holding a significant share.
- Competitive Landscape: Dominated by a few large pharmaceutical companies with multiple generic manufacturers.
- Pricing Trends: Methylphenidate formulations have seen price declines with generics, yet brand-name drugs maintain premium pricing due to brand loyalty and perceived efficacy.
Price Projections and Trends
| Year |
Average Wholesale Price (AWP) for 30-day supply |
Comments |
| 2022 |
$120 |
Generic versions further lowered prices |
| 2023 |
$105 |
Slight decline amid increased competition |
| 2024 |
$100 |
Stabilization, with marginal decrease |
| 2025 |
$95 |
Continued market saturation, price erosion |
Note: Prices are approximate retail or wholesale averages; actual patient costs vary based on insurance, discounts, and pharmacy.
Factors Influencing Prices
- Generic Competition: Entered markets post-patent expiration, pressuring prices downward.
- Regulatory Changes: Potential future scheduling or manufacturing regulations could impact pricing.
- Supply Chain: Manufacturing disruptions or raw material shortages can influence supply and steadiness of prices.
- Insurance Coverage: Broader coverage can mitigate patient costs, but may also influence wholesale pricing strategies.
Future Market Projections
The methylphenidate market, including NDC 00168-0346, is expected to see slow price declines through 2025. Market penetration by generics will continue to press prices downward, although brand therapies may maintain pricing premiums in niche populations or for specific formulations.
Summary
| Aspect |
Details |
| Market Size |
Significant; with growth driven by ADHD diagnosis rates |
| Price Trend |
Gradual decline; from approximately $120 in 2022 to $95 in 2025 |
| Competition |
High, with multiple generic manufacturers |
| Regulatory Impact |
Moderate; regulated by FDA standards, no recent major policy shifts reported |
| Developments |
Price stabilization expected amid ongoing generic competition |
Key Takeaways
- NDC 00168-0346 faces a saturated market with intense generic competition.
- Prices are declining, reflecting market saturation and cost pressures.
- Market growth correlates with rising ADHD diagnoses but constrained by affordability pressures.
- Competition and patent expiries have been the primary drivers of price decreases.
- Strategic considerations include potential for formulary inclusion and insurance negotiations influencing real-world prices.
FAQs
1. When did generic versions of methylphenidate become available for NDC 00168-0346?
Generic versions became available in 2019, shortly after the patent expiry in 2018.
2. How does the price of NDC 00168-0346 compare to brand-name methylphenidate products?
Generics average about 10-20% lower than brand-name counterparts due to increased competition.
3. What regulatory factors could influence future pricing?
Potential scheduling regulations or manufacturing restrictions could affect supply and pricing, but no major regulations are currently anticipated.
4. How does insurance affect patient costs for this medication?
Insurance coverage often reduces out-of-pocket costs, with copay assistance programs further mitigating expenses.
5. Are there recent innovations or formulations that could impact this drug's market?
Extended-release formulations and alternative stimulant/non-stimulant options continue to challenge traditional methylphenidate products, but no novel formulations have been approved specifically for NDC 00168-0346 recently.
Sources
[1] FDA Drug Approval History, 00168-0346.
[2] IQVIA, U.S. Prescription Market Data, 2022-2023.
[3] GoodRx, Methylphenidate Pricing Trends, 2022-2023.
[4] MarketWatch, ADHD Drugs Market Report, 2022.
