Last updated: March 1, 2026
What is NDC 51672-4209?
NDC 51672-4209 corresponds to Nuplazid (pimavanserin), developed by Acadia Pharmaceuticals. It is approved by the FDA for treating hallucinations and delusions associated with Parkinson’s disease psychosis (PDP). Approved in 2016, Nuplazid is marketed primarily as a treatment for neuropsychiatric symptoms in Parkinson’s disease.
Market Size and Demand Drivers
Patient Population
- Parkinson’s Disease: Approximately 1 million U.S. cases, with roughly 60–80% developing psychosis symptoms at some stage.
- PDP Prevalence: Estimated 30% of Parkinson’s patients experience psychosis, representing about 300,000 patients in the U.S.
Sales Trends (Post-Approval)
| Year |
Estimated U.S. Sales (USD) |
Key Highlights |
| 2017 |
$50M |
Launch period, initial penetration |
| 2018 |
$110M |
Broadened physician awareness |
| 2019 |
$250M |
Increased prescriber base, expanding indications |
| 2020 |
$350M |
Competitive landscape stabilization |
| 2021 |
$400M |
Market penetration plateau |
| 2022 |
$430M |
Post-pandemic recovery, new formulary inclusions |
Competitive Landscape
- Primary competitor: Clozapine (off-label for PDP)
- Emerging treatments: Pimavanserin’s unique mechanism as a selective 5-HT2A receptor inverse agonist provides a differentiated profile.
- Market barriers: Off-label use restrictions, side effect concerns, and prescriber familiarity influence growth.
Pricing Dynamics and Projections
Current Pricing
- Average Wholesale Price (AWP) for Nuplazid: approximately $740 per 30-tablet pack.
- Per-unit cost: around $25 per capsule.
- Reimbursement landscape: Varies with insurer policies, with Medicare covering a majority of PDP treatments.
Price Trends (Historical)
| Year |
Average Wholesale Price (USD) |
Remarks |
| 2016 |
$700 |
Launch price, initial price setting |
| 2018 |
$730 |
Slight increases, market stabilization |
| 2020 |
$740 |
No significant change after initial increments |
| 2022 |
$745 |
Mild increase, aligned with CPI adjustments |
Future Price Projections (2023–2028)
| Year |
Predicted Wholesale Price (USD) |
Rationale |
| 2023 |
$750 |
Inflation adjustments, stable demand |
| 2024 |
$755 |
Potential for modest increase due to supply chain costs |
| 2025 |
$760 |
Increment aligned with inflation, no major policy changes |
| 2026 |
$770 |
Possible price hike driven by market consolidation |
| 2027 |
$780 |
Continued inflation, ongoing demand stability |
Pricing Influences
- Impact of Competition: Introduction of generics or new therapies could pressure prices downward.
- Reimbursement policies: CMS and private insurers may negotiate discounts, affecting net prices.
- Regulatory changes: New indications or expanded approvals could influence pricing strategies.
Market Outlook
- Growth trajectory shows steady sales over the next five years, with income stabilization around $400–$500M annually in the U.S.
- Global expansion remains limited but could contribute additional growth, especially in Europe and Asia, where Parkinson’s disease rates are rising.
- Pricing stability is expected unless significant competition or regulatory shifts occur.
Key Takeaways
- NDC 51672-4209 (Nuplazid) maintains a strong market position within Parkinson’s disease psychosis.
- The U.S. market is projected to grow modestly, reaching approximately $460–$500 million annually by 2028.
- Prices are expected to increase slightly, averaging a 1–2% annual rise, contingent upon inflation and market conditions.
- Revenue growth depends on prescriber adoption, payer reimbursements, and potential competition.
- Strategic positioning should consider pipeline developments, especially generics and alternative therapies.
FAQs
1. What factors could lower the price of Nuplazid in the future?
Introduction of generic pimavanserin, increased competition from alternative therapies, and policy pressure on drug pricing could reduce net prices.
2. How does disease prevalence affect market size?
Higher epidemiological rates, especially underdiagnosis or increased awareness, expand the potential patient pool, boosting sales.
3. What role do insurance payers play in pricing?
Payers negotiate discounts and formulary placements, impacting the net revenue and accessibility for patients.
4. Are there regional variations in pricing?
Yes, international markets exhibit different pricing structures, influenced by regulatory policies, healthcare systems, and market competition.
5. What are the main risks to price stability?
Regulatory changes, patent litigation, or the introduction of more effective competitors could pressure prices downward.
References
[1] FDA (2016). FDA approves Nuplazid to treat hallucinations and delusions associated with Parkinson’s disease psychosis.
[2] IQVIA (2022). Pharmaceutical Market Data.
[3] Medicare Provider Payment Data (2022). Reimbursement trends for Parkinson’s therapies.
