Last updated: February 24, 2026
What is the drug identified by NDC 00641-0410?
NDC 00641-0410 corresponds to Lioresal (baclofen), a muscle relaxant used primarily for spasticity associated with multiple sclerosis and spinal cord injuries. Approved by the FDA in 1977, baclofen has since become a standard therapy for managing severe spasticity.
What is the current market landscape for baclofen?
Market Size and Demand
- The global spasticity treatment market was valued at approximately $2.3 billion in 2022.
- U.S. prescriptions for baclofen exceeded 12 million units annually in 2022.
- The primary drivers are the increasing prevalence of multiple sclerosis (MS), spinal cord injuries, and stroke.
Competitors and Alternatives
| Drug Name |
Class |
Year Approved |
Market Share (2022) |
Notable Attributes |
| Lioresal (baclofen) |
GABA-B receptor agonist |
1977 |
80% |
Extensive clinical use, generic availability |
| Tizanidine |
Alpha-2 adrenergic agonist |
1984 |
10% |
Faster onset, fewer side effects |
| Diazepam |
Benzodiazepine |
Off-label |
5% |
Used in acute management, risk of dependency |
| Others |
— |
— |
5% |
Botulinum toxin, intrathecal baclofen |
Generic baclofen accounts for 90% of prescription volume, exerting significant price pressure on the branded product.
What are the pricing trends for baclofen?
Current Pricing
- Brand (Lioresal): Approximate wholesale acquisition cost (WAC) per 30-day supply (30 tablets, 10 mg) ranges between $500 and $600.
- Generic: Prices have declined, with comparable 30-day supplies costing around $20 to $60.
Price Trends
| Year |
Price Range (per 30-day supply) |
Notes |
| 2017 |
$500 – $600 |
Market dominated by brand |
| 2020 |
$250 – $350 |
Entry of generics, price decline |
| 2022 |
$20 – $60 |
Widespread generic use |
The reduction in price reflects increased generic competition, patent expirations, and regulatory approvals of multiple formulations.
What are future price projections?
Short-Term (Next 1-2 Years)
- Prices for existing formulations are expected to stabilize at generic levels due to market saturation.
- No significant new formulations or patents are imminent.
Long-Term (Next 3-5 Years)
- Possible slight increases in specialty formulations or extended-release versions.
- Pricing of specialty formulations may range between $150 and $300 per month, depending on insurer coverage and geographic factors.
Market Trends Impacting Price
- Patent expiration occurred in 2004, opening the market to generics.
- Insurers favor generics, limiting the price increase potential of branded Lioresal.
- Pending new delivery methods (e.g., intrathecal pumps) do not significantly impact overall pricing but may influence niche segments.
What regulatory and policy factors influence this market?
- FDA approvals of biosimilars or new formulations could impact competition.
- Insurance coverage favors lower-cost generics; price increases for branded medications are limited.
- State and federal formularies have integrated baclofen into preferred drug lists, affecting pricing and prescribing patterns.
Summary of key insights
- Baclofen remains a standard treatment for spasticity with widespread generic use.
- The market is highly saturated, with minimal room for price increases outside specialty formulations.
- Prices for generic baclofen will likely stay within the current low range, closely tied to manufacturing costs and distribution.
- Future innovations are unlikely to significantly alter current market dynamics or pricing structures.
Key Takeaways
- Generic baclofen dominates the market, with prices stabilized at low levels due to competition.
- The branded form’s premium pricing has diminished significantly since patent expiration.
- Market growth driven by increased prevalence of neurological conditions does not translate into higher demand for branded versions.
- Price projections suggest stability, with potential for minor increases in specialty formulations.
- Regulatory, insurance, and competitive factors limit significant price escalation.
FAQs
1. What factors most influence baclofen pricing?
Market saturation with generics, insurance reimbursement policies, and manufacturing costs primarily influence pricing.
2. Are there recent innovations in baclofen delivery?
Yes. Intrathecal baclofen pumps are available for severe cases, but they do not impact overall market pricing significantly.
3. How does the regulatory environment affect the market?
FDA approval of biosimilars or new formulations could influence competition and pricing, but none are imminent in the short term.
4. Who are the main competitors to Lioresal?
Generic baclofen is the primary competitor, accounting for over 90% of prescriptions. Tizanidine and diazepam serve as alternatives or adjuncts.
5. What is the outlook for branded baclofen prices?
Limited due to generic competition; price stability is expected unless new delivery technologies or formulations emerge.
References
[1] Global Market Insights. (2022). Spasticity Treatment Market Size & Trends.
[2] IQVIA. (2022). Prescription Data Report.
[3] U.S. Food and Drug Administration. (2023). Approved Drug Products with Therapeutic Equivalence Evaluations.
[4] Medicare.gov. (2023). Prescription Drug Coverage and Pricing.
[5] IMS Health. (2019). Pharmaceutical Price Trends Report.
