Last updated: March 2, 2026
What is NDC: 62332-0238?
NDC 62332-0238 refers to a specific drug product listed in the National Drug Code registry. As of the latest data, it corresponds to Fasinumab (developed by Regeneron Pharmaceuticals and Teva Pharmaceuticals), an investigational drug aimed at pain management, primarily targeting osteoarthritis joint pain and chronic low back pain. It is a monoclonal antibody designed to inhibit nerve growth factor (NGF).
Current Regulatory Status
- Phase 3 clinical trials completed or ongoing.
- No FDA approval yet.
- Pending submission for regulatory review, expected in 2024.
Market Landscape
Therapeutic Area: Chronic Pain Management
| Segment |
Market Size (2022) |
CAGR (2022-2027) |
Key competitors |
| Osteoarthritis pain |
$7.5 billion |
4.8% |
NSAIDs, opioids, duloxetine |
| Chronic low back pain |
$4.2 billion |
4.2% |
NSAIDs, corticosteroids, physio |
Unmet Needs and Differentiators
- Existing therapies (NSAIDs, opioids) carry safety concerns.
- Biological agents like tanezumab (another NGF inhibitor) have experienced safety issues but demonstrated efficacy.
- Fasinumab targets the same pathway with a potentially improved safety profile.
Market Entry Timeline
- Regulatory approval expected around late 2024.
- Commercial launch predicted Q1 2025, contingent on successful registration.
Price Projections
Pricing Assumptions
- Initial average wholesale price (AWP): $5,500 per dose.
- Based on comparable biologics such as tanezumab and other monoclonal antibodies used for pain.
Pricing Strategy
- Tiered pricing, with higher prices during initial launch.
- Potential discounts for payers, especially in negotiated Medicare and Medicaid prices.
- Price stabilization after first two years, reflecting widespread adoption.
Projected Per-Patient Costs
| Year |
Estimated Annual Cost |
Comments |
| 2025 |
$66,000 |
One dose every three months, four doses/year. |
| 2026 |
$66,000 |
Stable pricing assumed. |
| 2027 |
$65,000 |
Slight decrease with increased competition. |
Market Penetration and Revenue Projections
| Year |
Prescriptions (monthly) |
Market Share |
Revenue (USD millions) |
| 2025 |
20,000 |
10% |
$132 |
| 2026 |
40,000 |
15% |
$396 |
| 2027 |
70,000 |
20% |
$1,430 |
Data based on assumed adoption rates, competitor presence, and payer coverage patterns.
Competitive Analysis
| Competitor |
Key Features |
Price Range (per dose) |
Approval Status |
| Tanezumab |
NGF monoclonal antibody, phase 3 trials |
~$7,000 |
Pending FDA approval |
| NSAIDs (e.g., celecoxib) |
Oral, widely used, safety issues at high doses |
$1 - $2 per pill |
Approved |
| Opioids |
Highly effective, regulatory concerns, safety issues |
Varies, ~$10 per dose |
Approved |
Fasinumab's success depends on its safety profile and reimbursement strategies, with the biological approach offering the potential for superior efficacy and fewer side effects.
Key Factors Affecting Price and Market Share
- Regulatory approval: Delays or safety concerns could limit early adoption.
- Payer coverage: Negotiated discounts impacting net prices.
- Competitive landscape: Entry timing of generic biosimilars or alternative therapies.
- Patient acceptance: Willingness to adopt biologics over traditional therapies.
Risks and Regulatory Considerations
- Safety profile: NGF inhibitors have historically faced black box warnings due to joint safety risks. Fasinumab's approval hinges on demonstrating a favorable safety profile.
- Pricing regulation: Payer negotiations and potential price caps can influence final prices and revenue.
- Market dynamics: Rapid entry of alternative therapies could reduce market share.
Key Takeaways
- The drug is in late-stage development, with potential approval in 2024-2025.
- Initial pricing likely around $5,500 per dose, with annual per-patient costs approx. $66,000.
- Revenue projections suggest $132 million in 2025, growing to over $1.4 billion by 2027, assuming moderate market penetration.
- Competitive landscape centers on efficacy, safety, and payer access, especially against opioids and NSAIDs.
- Key risks involve safety concerns associated with NGF inhibitors, regulatory hurdles, and payer negotiations.
FAQs
Q1: When is Fasinumab expected to reach the market?
A1: Regulatory approval is anticipated around late 2024, with market launch in early 2025.
Q2: What is the expected initial price per dose?
A2: Approximately $5,500, based on comparable biologics.
Q3: How does Fasinumab compare with other NGF inhibitors?
A3: It may offer a better safety profile, though its efficacy and safety are still under evaluation.
Q4: What factors could impact the drug's revenue potential?
A4: Safety concerns, payer coverage restrictions, competitive entry, and regulatory delays.
Q5: Which market segments will the drug target?
A5: Osteoarthritis pain and chronic low back pain, which collectively represent a multibillion-dollar market.
References
[1] IQVIA. (2022). The Global Use of Medicine in 2022.
[2] Evaluate Pharma. (2022). 2022 World Preview: Outlook to 2027.
[3] U.S. Food and Drug Administration. (2023). Fasinumab: Regulatory filings and clinical trial data.
[4] MarketWatch. (2022). Biologic drugs market overview.
[5] Statista. (2022). Pain management market size and forecasts.
