Last updated: February 24, 2026
What is NDC 83324-0217?
NDC 83324-0217 is a drug identified as Baclofen Injection, 50 mg/mL, supplied in a 30 mL vial. It is primarily used to treat spasticity related to multiple sclerosis, spinal cord injuries, and other neurological conditions.
Market Overview
Current Market Size
The baclofen injection market, valued at approximately $125 million in 2022, is projected to grow at a compound annual growth rate (CAGR) of 4.5% through 2027. The growth is driven by:
- Increased prevalence of neurological disorders.
- Aging population.
- Adoption of injectable therapies in clinical settings.
Competitive Landscape
Key competitors include:
| Product |
Formulation |
Estimated Market Share (2022) |
Price Range (per vial) |
| Lioresal IV* |
Oral, injectable |
55% |
$3.50 - $5.00 |
| Gablofen |
Oral, injectable |
30% |
$2.80 - $4.50 |
| Baclofen (generic) |
Injectable |
10% |
$2.50 - $4.00 |
| NDC 83324-0217 |
Injectable (50 mg/mL) |
5% |
$5.50 - $7.00 |
*Lioresal is the brand name for oral baclofen, but its injectable form is used off-label.
Regulatory Status
- Approved by the FDA in 2017.
- No recent exclusivity extensions.
- No significant patent protections currently in place for this formulation, increasing its generic competition.
Price Projections
Short-term (2023-2025)
- The average price per vial is expected to remain between $5.50 and $7.00.
- Volume growth projected at 5% annually, driven by increased diagnosis and acceptance.
- Price stability expected due to limited patent constraints and generic competition.
Medium-term (2026-2030)
- Anticipate slight decline in per-vial prices to a range of $5.00 - $6.50 as generics expand market penetration.
- Price reduction pressures will be mitigated by manufacturing costs and supplier agreements.
- Volume increases will moderate to 3-4% annually.
Key Pricing Factors Influencing Future Value
- Patent expiry and generic entry are the primary determinants of price decline.
- Healthcare policy shifts towards cost containment may exert downward pressure.
- Supply chain factors such as raw material costs and manufacturing capacity.
Revenue Projections
| Year |
Market Volume (vials) |
Estimated Revenue (millions USD) |
| 2023 |
1.2 million |
$6.6 - $8.4 |
| 2025 |
1.4 million |
$7.7 - $9.8 |
| 2027 |
1.6 million |
$8.0 - $10.4 |
| 2030 |
1.8 million |
$9.0 - $11.7 |
Downward price trends are counterbalanced by volume growth, sustaining overall revenue levels within the projected period.
Key Market Risks and Opportunities
Risks
- Entry of biosimilar or alternative therapies.
- Regulatory delays or modifications affecting approval pathways.
- Healthcare reforms affecting reimbursement.
Opportunities
- Expansion into new indications, such as spasticity in pediatric populations.
- Development of combination therapies to enhance efficacy.
- Growth in emerging markets with expanding healthcare infrastructure.
Conclusion
NDC 83324-0217 operates within a stable but highly competitive market. Current pricing reflects limited patent protection, with prices ranging from $5.50 to $7.00 per vial. Over the next five years, prices are likely to decline slightly, constrained by high manufacturing costs and the gradual increase in generics. Revenue will be driven primarily by volume growth, which is projected at 3-5% annually.
Key Takeaways
- The drug's market size is approximately $125 million, with moderate growth prospects.
- Price per vial is expected to average around $6.00 over the next five years.
- Competition from generics and regulatory shifts will influence pricing and market share.
- Volume growth will sustain revenue, despite modest price declines.
- Opportunities exist in new indications and emerging markets.
FAQs
-
What factors most influence the price of NDC 83324-0217?
Patent status, entry of generics, manufacturing costs, and healthcare reimbursement policies.
-
How does the market for this injectable compare to oral formulations?
Injectables account for approximately 25% of the baclofen market, with growth driven by clinical settings and specific indications.
-
Are there any upcoming regulatory changes that could impact this drug?
No significant regulatory changes are currently expected within the next two years.
-
What is the primary driver of revenue for this drug?
Volume growth, as prices stabilize or decline slightly due to generic competition.
-
Which emerging markets could influence future demand?
Countries including China, India, and Brazil are expanding their healthcare infrastructure, increasing demand for affordable injectable therapies.
Citations
[1] MarketResearch.com (2022). Global Baclofen Market Analysis.
[2] IQVIA (2022). Pharmaceutical Market Trends Report.
[3] U.S. Food and Drug Administration (2022). Approval Data for Baclofen.
[4] EvaluatePharma (2023). Drug Price Trends and Forecasts.
[5] Healthcare Investment Reports (2023). Emerging Markets in Neurological Therapy.
