Last updated: February 17, 2026
What is the Drug Corresponding to NDC 53746-0146?
The National Drug Code (NDC) number 53746-0146 corresponds to Vessemir (safinamide tablets). Safinamide is approved as an adjunct therapy for Parkinson’s disease, typically used alongside levodopa in patients experiencing motor fluctuations.
Regulatory Status:
- Approved by the FDA in July 2017 for Parkinson’s disease.
- Also approved in multiple countries under regulatory agencies like the EMA.
Therapeutic Class:
- Monoamine oxidase B (MAO-B) inhibitor
- Enhances dopaminergic activity through reversible MAO-B inhibition
Market Size and Dynamics
Current Market Overview
- Market Players: The primary competitor medications include selegiline, rasagiline, and safinamide.
- Sales Data: The global Parkinson’s disease drug market generated approximately $4.7 billion in 2022 (IQVIA).
- Safinamide Revenue: Estimated to account for roughly $220 million globally in 2022, with potential for expansion given increased diagnosis rates and aging populations.
Market Drivers
- Rising prevalence of Parkinson’s disease, estimated at 10 million globally.
- Increasing adoption of MAO-B inhibitors as adjunct therapy.
- Growing aging populations in North America, Europe, and Asia-Pacific regions.
Market Constraints
- Limited differentiation among MAO-B inhibitors.
- Price sensitivity within healthcare systems.
- Patent protection status and generic entry timelines.
Competitive Landscape
| Drug Name |
Mechanism |
Patent Status |
Price (per unit) |
Market Share (2022) |
Notes |
| Safinamide (NDC 53746-0146) |
Reversible MAO-B inhibitor |
Patent active until 2029 |
~$800 (per 30-count 50mg tablets) |
20% |
Post-approval growth potential |
| Rasagiline |
Irreversible MAO-B inhibitor |
Patent expired in US |
~$600 |
40% |
Established brand, generic options |
| Selegiline |
Irreversible MAO-B inhibitor |
Generic available |
~$300 |
15% |
Mainly in oral and patch forms |
| Others |
Various mechanisms |
- |
Varies |
25% |
Includes emerging therapies |
Price Projections
Short-Term (Next 1-2 Years)
- Pricing Stability: Safinamide's price is expected to remain around $800-$900 per 30-pack, owing to patent exclusivity until 2029.
- Market Uptake: Moderate increase in prescriptions as awareness grows; sales projected to rise by 10-15% annually.
Mid to Long-Term (3-5 Years)
- Patent Expiry Impact: Introduction of generics expected post-2029 could reduce unit prices by up to 50%.
- Market Penetration: Increasing adoption in emerging markets driven by expanding healthcare coverage.
- Pricing Pressure: Competitive pricing may push average wholesale prices down to ~$400-$600 per 30-pack.
Risk Factors Influencing Price
- Regulatory delays or withdrawals.
- New safety concerns or adverse reports diminishing demand.
- Entry of novel therapies that outperform MAO-B inhibitors.
- Policy changes in drug reimbursement frameworks.
Regulatory and Policy Considerations
- Approval extensions in additional indications could broaden market size.
- Price adjustments driven by healthcare authorities, especially in countries with rigid drug pricing policies (e.g., Canada, EU countries).
- FDA’s ongoing focus on biosimilar and generic entry could influence timing of price reductions.
Key Takeaways
- NDC 53746-0146 (safinamide) targets an expanding Parkinson’s disease market with growing demand.
- Current price points are high relative to older MAO-B inhibitors but are supported by patent exclusivity until 2029.
- Revenue growth hinges on increased adoption, especially in markets lacking generic competition.
- Price erosion anticipated post-patent expiry could significantly impact profitability.
- Competitive landscape favors products like rasagiline, which secure larger market shares.
FAQs
1. What factors influence safinamide’s market share?
Market share depends on prescriber preference, safety profile, and relative efficacy. Safinamide’s reversibility and additional mechanisms (e.g., sodium channel blockade) could give it an edge over older, irreversible MAO-B inhibitors.
2. When will generic versions of safinamide enter the market?
Post-2029, assuming patent protection is not extended or litigated. Generic entry typically reduces prices substantially within 12-24 months.
3. How does safinamide’s price compare to other Parkinson’s drugs?
It is currently more expensive than older MAO-B inhibitors like selegiline, reflecting newer patent status and formulation. Its cost is comparable with other branded adjunct therapies.
4. What is the potential for expanding safinamide’s indications?
Research into non-motor symptoms of Parkinson’s and other neurodegenerative disorders could expand its use, but regulatory approvals would be necessary.
5. How do health insurance policies impact safinamide’s sales?
Coverage restrictions or high copayments can limit access, especially in countries with strict formulary controls, influencing overall market penetration.
Citations:
[1] IQVIA. “Global Parkinson's Disease Market Report,” 2022.
[2] FDA. “Safinamide (Xadago) approved in the U.S.,” 2017.
[3] EMA. “Assessment report on safinamide,” 2017.
