Last updated: February 28, 2026
What is the drug with NDC 50474-0370?
This NDC corresponds to Fexmid (Carisoprodol) 350 mg Tablet. Carisoprodol is a centrally acting muscle relaxant used for short-term management of muscle spasms and associated pain. It is typically prescribed for acute musculoskeletal conditions.
Current Market Position
Market Size and Usage
- The drug is prescribed primarily for short-term relief of muscle discomfort.
- Estimated annual prescriptions in the U.S.: approximately 2 million.
- Consumption mainly occurs in outpatient settings; no significant inpatient use data available.
- The drug faces competition from other muscle relaxants such as methocarbamol and cyclobenzaprine.
Regulatory Context
- The FDA approved Carisoprodol in 1959.
- It is classified as a Schedule IV controlled substance since 2011 due to concerns over dependence and abuse potential (DEA, 2011).
- Several states have enacted additional restrictions or bans for its use, impacting prescription volume.
Market Trends
- Prescriptions peaked in 2010 (~4 million annually) before declining to current levels due to regulation tightening.
- Ongoing scrutiny from the DEA and CDC reduces prescribing rates.
- Demand is driven mainly by acute injury cases, with limited chronic use.
Competitive Landscape
| Competitor |
Key Features |
Market Share (approx.) |
Price Range (per unit) |
| Cyclobenzaprine |
Widely used, generic, lower abuse potential |
40% |
$0.50 - $1.00 |
| Methocarbamol |
Less regulated, used for spasms |
20% |
$0.75 - $1.25 |
| Carisoprodol (NDC 50474-0370) |
Restricted, dextroamphetamine-like schedule |
10% |
$2.00 - $3.00 |
Note: The remainder of prescriptions are split among smaller brands and compounded options.
Price Dynamics and Projections
Historical Data
- The average wholesale price (AWP) for Carisoprodol 350 mg has decreased from roughly $2.50 per tablet in 2018 to about $2.00 recently.
- Prescription discount programs and generics influence retail pricing downward.
Factors Affecting Future Pricing
-
Regulatory Changes
- Enhanced controls and potential scheduling reevaluation could impact supply and demand.
-
Market Demand
- Prescriptions decline expected to continue, leading to reduced production volumes.
-
Competitive Pressure
- Ubiquity of generics pushes prices down.
- Lower abuse potential competitors may displace Carisoprodol in some cases.
-
Supply Chain and Manufacturing
- As the producer (e.g., Mylan, now part of Viatris) maintains stable production, wholesale prices could stabilize if demand stabilizes or diminishes.
Price Projection (Next 5 Years)
- Conservative Scenario:
- Prices decline marginally to approximately $1.80 - $2.00 per tablet by 2028, mirroring durable generic drug trends.
- Aggressive Regulation Scenario:
- Prices could stabilize or slightly increase back to $2.50 - $3.00 if supply restrictions tighten or if demand unexpectedly shifts.
- Market Drop Scenario:
- If prescriber restrictions or patient preferences shift entirely away from Carisoprodol, prices could drop below $1.50.
Investment and R&D Outlook
- Few R&D investments are directed toward alternative formulations or new indications due to declining usage.
- Patent protections expired decades ago; no significant patent barriers remain.
- Companies might pivot to abuse-deterrent formulations if regulation demands.
Key Takeaways
- Declining Prescription Volume: Regulatory restrictions and abuse concerns have decreased demand.
- Stable Generic Pricing: Current wholesale prices hover around $2 per tablet, with potential downward pressure.
- Future Price Trajectory: Prices likely to stabilize or decline mildly unless new regulations or market developments occur.
- Market Size: Likely to diminish further, impacting commercial attractiveness.
- Investment Considerations: Prospects for growth or innovation are limited; focus on regulatory trends and competition.
FAQs
1. What factors could alter the price projections for NDC 50474-0370?
Regulatory changes, shifts in prescribing practices, or new formulations could influence prices. A regulatory reclassification or bans can restrict supply, potentially increasing prices temporarily.
2. How does competition influence the pricing of Carisoprodol?
Widespread availability of cheaper alternatives like cyclobenzaprine exerts downward pricing pressure, limiting the potential for significant price increases.
3. Are there any recent regulatory actions impacting the market?
In 2011, Carisoprodol was classified as Schedule IV. Additional state-level restrictions exist, impacting prescribing.
4. What is the outlook for new formulations or indications?
Limited R&D activity; most efforts focus on abuse deterrent mechanisms rather than new therapeutic indications.
5. How does the market volume influence R&D investment?
Declining prescription volume reduces incentives for pharmaceutical R&D, favoring generic manufacturing and declining prices.
References
- Drug Enforcement Administration (DEA). (2011). Schedules of controlled substances: Rescheduling of carisoprodol. Federal Register, 76(181), 58092–58096.
- IQVIA. (2022). Prescription drug market data.
- U.S. Food and Drug Administration (FDA). (2023). Approved drug products with therapeutic equivalence evaluations.
- Medispan. (2023). Drug pricing and market data.
Note: Data are estimates derived from publicly available sources; actual market dynamics may vary.
