Last updated: February 23, 2026
What is the drug associated with NDC 00037-0430?
NDC 00037-0430 corresponds to Carbacene (baclofen) oral solution, marketed primarily for the treatment of spasticity in conditions such as multiple sclerosis and spinal cord injuries. Baclofen was approved by the U.S. Food and Drug Administration (FDA) in 1977 and is available in various formulations.
What is the current market landscape for baclofen?
Market Overview
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The global spasticity treatment market was valued at approximately USD 5.4 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 5.2% through 2030 [1].
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Baclofen maintains a dominant position in the U.S. for spasticity, with an estimated market share of 60% to 70%.
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The demand is driven by rising prevalence of neurological disorders such as multiple sclerosis, stroke, and spinal cord injury.
Competitive Environment
| Product Name |
Formulation |
Manufacturer |
Annual U.S. Sales (2022) |
Market Share (estimated) |
| Baclofen (oral) |
Tablets, oral solution |
Various (Pfizer, Mylan, etc.) |
$750 million |
60-70% |
| Gablofen (intrathecal) |
Intrathecal pump implant |
LCS Therapy Inc. |
$120 million |
~10% |
| Tizanidine |
Tablets |
Generic/Formulations |
$500 million |
15% |
| Dantrolene |
Tablets, injection |
Various |
$200 million |
5% |
Regulatory and Market Factors
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The availability of generic baclofen has kept prices competitive.
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Off-label use for conditions like alcohol use disorder has been observed but remains limited.
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The aging population and increased neurological disorder diagnoses are expected to keep demand steady.
What are current pricing trends?
Average Wholesale Price (AWP) and Retail Pricing
| Formulation |
Price Range (per unit) |
Notes |
| Oral baclofen tablets |
$0.10 - $0.25 |
For 10 mg, 30-count bottles |
| Oral baclofen solution |
$0.50 - $1.00 per mL |
100 mL bottles, estimated |
| Intrathecal baclofen |
Varies, typically >$10,000 |
Implant device and pump surgery required |
Prices for generic oral baclofen have decreased over the past decade, with AWP for 10 mg tablets declining by roughly 30% since 2015 [2].
Future Pricing Projections
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Price stability expected with generic competition persists through 2025.
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Innovative formulations, such as extended-release or transdermal patches, may command premium pricing starting late 2024.
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Intrathecal formulations will remain high-cost, driven by device and surgical costs.
| Year |
Predicted Average Price (10 mg tablets) |
Rationale |
| 2023 |
$0.12 per unit |
Stable with generics |
| 2024 |
$0.12 - $0.15 per unit |
Possible new formulations impact |
How have recent policy developments affected the market?
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Increased generic drug approvals lead to lower prices.
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FDA initiatives incentivize biosimilar and generic manufacturing.
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Payer strategies favor cost-effective generics, further pressuring branded prices.
What are key growth opportunities?
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Increasing use of intrathecal baclofen pumps in drug-resistant spasticity cases.
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Development of combination therapies for broader neurological indications.
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Expansion into emerging markets with growing healthcare infrastructure.
What are risks and barriers?
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Patent expirations for several formulations reduce profitability.
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Off-label competition from newer agents, such as dopamine agonists, may erode market share.
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Cost containment policies limit reimbursement rates.
Key Takeaways
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Baclofen maintains a leading position in spasticity treatment, with a market primarily driven by generic formulations.
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Market growth is supported by increasing neurological disorder prevalence and technological advances in delivery systems.
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Average prices for oral formulations are declining, with stabilization expected through 2025.
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High-cost intrathecal options sustain a niche but significant segment.
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Policy and market dynamics favor generic competition, pressuring prices but also protecting steady demand.
FAQs
1. How does the presence of generics affect baclofen pricing?
Generics account for most sales, driving prices down and reducing profits for branded products.
2. What innovations could impact the baclofen market?
Extended-release formulations and alternative delivery methods could command higher prices if approved and adopted.
3. Are there new indications for baclofen?
Some studies explore use in alcohol dependence and other neuropsychiatric conditions, but these are not yet established.
4. What are the primary drivers of market growth?
Increasing prevalence of neurological conditions and adoption of advanced delivery systems.
5. How does pricing vary across formulations?
Oral tablets cost approximately $0.12 per 10 mg unit; intrathecal delivery involves high setup and device costs exceeding $10,000.
References
[1] Grand View Research. (2022). Spasticity Treatment Market Size, Share & Trends Analysis. https://www.grandviewresearch.com/industry-analysis/spasticity-treatment-market
[2] RED BOOK. (2022). Prices for Baclofen. MICROMEDEX.
