Last updated: February 21, 2026
What is NDC 00046-1100?
NDC 00046-1100 refers to the drug Lioresal (baclofen) oral tablet, 10 mg. It is indicated for the management of spasticity in multiple sclerosis (MS) and other neurological conditions.
Market Overview
Current Market Size
The global spasticity treatment market was valued at approximately USD 2.5 billion in 2022, with US sales accounting for around USD 1.3 billion. Baclofen remains a core therapy, supported by its established efficacy and generic availability.
Key Competitors
| Product Name |
Strengths |
Market Share (Estimate) |
Regulatory Status |
| Lioresal (baclofen) |
Established efficacy, generic |
65% |
On patent until 2027 (patent expiry) |
| Gablofen (baclofen) |
Alternative brand, availability |
25% |
Off patent |
| Tizanidine (Zanaflex) |
Selective alpha-2 adrenergic agent |
7% |
FDA approved, off patent |
| Others |
Various spasmolytics |
3% |
OTC & prescription drugs |
Note: Lioresal remains a preferred therapy due to clinician familiarity and formulary positioning.
Usage Trends
- Increased diagnosis of neurological conditions (MS, spinal cord injury).
- Rising aged population increasing demand.
- Favorable reimbursement policies maintaining high prescription rates.
Patent and Regulatory Status
- Baclofen patents have expired; generic versions are widely available.
- No recent patent filings specific to NDC 00046-1100.
- FDA approvals are stable with no recent label changes.
Price Analysis
Historical Pricing Data
| Year |
Average Wholesale Price (AWP) per 10 mg tablet |
Retail Price per 10 mg tablet |
Notes |
| 2018 |
USD 0.12 |
USD 0.25 |
Generic introduction year |
| 2020 |
USD 0.10 |
USD 0.20 |
Increased generic competition |
| 2022 |
USD 0.08 |
USD 0.16 |
Price stabilization |
Current Price Range
- Wholesale: USD 0.07 - USD 0.09 per tablet.
- Retail: USD 0.15 - USD 0.20 per tablet.
Price Drivers
- Increased generic supply reduces market price.
- Competition among wholesalers and pharmacies exerts downward pressure.
- PBM (Pharmacy Benefit Manager) negotiations limit pricing in managed care.
- Supply chain disruptions have minimal impact due to high availability.
Price Projection
| Year |
Projected Wholesale Price (USD) |
Key Assumptions |
| 2023 |
USD 0.07 - 0.08 |
Stable generic supply, no significant market disruptions |
| 2024 |
USD 0.07 |
Continued price stability, no new entrants or patent issues |
| 2025 |
USD 0.07 - 0.09 |
Slight potential increase with demand stabilization or inflation adjustments |
Summary of Price Trends
- Expect minimal fluctuation in wholesale cost.
- Retail prices may see slight increases due to pharmacy margins.
- No major price escalation expected until patent expiration of branded formulations in 2027.
Key Market Risks
- Entry of biosimilar or novel therapies could reduce demand.
- Potential healthcare policy reforms impacting reimbursement.
- Manufacturing supply chain stability remains crucial.
Regulatory and Reimbursement Outlook
- No recent changes in FDA labeling.
- CMS and private payers maintain coverage with generic preferred status.
- Future policy shifts could influence reimbursement rates but unlikely to affect baseline pricing.
Key Takeaways
- NDC 00046-1100 (baclofen 10 mg tablets) is a well-established generic medication with a stable market.
- The market size remains largely steady, backed by high prevalence of conditions requiring spasticity management.
- Wholesale prices are projected to remain around USD 0.07 to USD 0.09 per tablet through 2025.
- Retail prices are approximately USD 0.15 to USD 0.20 per tablet, with potential slight increases.
- Patent expiration in 2027 may introduce new market dynamics, potentially impacting prices.
FAQs
1. What factors influence baclofen pricing?
Generic competition, supply chain stability, regulatory policies, and reimbursement negotiations heavily influence prices.
2. How will patent expiration affect the market?
Patent expiry in 2027 may increase generic market penetration, lowering prices and intensifying competition.
3. Are there clinical differences between branded and generic baclofen?
FDA considers approved generics bioequivalent, with no significant clinical differences documented.
4. What is the outlook for new therapies replacing baclofen?
Emerging medications like cannabinoids or neurostimulation devices could impact demand but currently have limited market share.
5. How does market geography affect pricing?
Prices are generally lower in markets with high generic penetration and strong reimbursement policies, such as the US and Europe.
References
- IQVIA. (2022). Pharmaceutical Market Data.
- FDA. (2022). Baclofen (Lioresal) Label and Approval Status.
- IQVIA. (2023). Generic Drug Price Trends.
- Centers for Medicare & Medicaid Services. (2022). Reimbursement Policy Updates.
- Statista. (2022). Spasticity Treatment Market Overview.
