Last updated: March 13, 2026
What is the drug associated with NDC 46122-0101?
The NDC 46122-0101 corresponds to Apomorphine Hydrochloride Injection. It is approved by the FDA for the treatment of Parkinson's disease, specifically to treat "off" episodes associated with long-term levodopa therapy.
Current Market Status
Market Size and Usage
- Estimated global market size (2022): $250 million. Dominated by North America, which accounts for approximately 70% of sales.
- US market share: 65% of global sales. Estimated at $163 million in 2022.
- Patient population: Parkinson’s disease affects approximately 1 million Americans, with around 30% experiencing "off" episodes at any given time.
Competitive Landscape
- Major competitors:
- Apokyn (brand name for the same drug, made by Osmotica Pharmaceuticals)
- Generic apomorphine formulations
- Non-invasive delivery options (e.g., inhalers, subcutaneous pumps)
- Market entrants: Limited recent entrants; barriers include injection-specific administration and regulatory requirements.
- Pricing dynamics: Traditionally high-cost due to the injectable form and specialty drug status.
Price Trends and Projections
Current Pricing (2023)
- Brand name (Apokyn):
- Average wholesale price (AWP): approximately $2,500 per 10 mL vial.
- Patient out-of-pocket: varies, with insurance typically covering 70-90% for approved patients.
- Generic formulations:
- Price range: $1,800—$2,200 per 10 mL vial, depending on supplier.
Price Drivers
- Manufacturing complexity due to sterile injection production.
- Regulatory pathways affecting approval of generics.
- Insurance reimbursement rates.
- Potential for biosimilar or generic entry affecting price dynamics.
Future Projections (Next 5 Years, 2023–2028)
| Year |
Estimated Market Size (USD million) |
Key Factors |
| 2023 |
250 |
Stable demand, limited new competitors |
| 2024 |
255 |
Slight growth due to increasing Parkinson’s prevalence |
| 2025 |
260 |
Patent protections for key formulations stable |
| 2026 |
265 |
Entry of generic alternatives possible |
| 2027 |
275 |
Potential price competition, volume increases |
| 2028 |
280 |
Market maturity, slight price decline expected |
Price Outlook
- Potential decline: 10-15% if multiple generics enter the market.
- Stable prices: If brand retains exclusivity or biosimilar development stalls.
- Increased costs: Production and regulatory compliance could pressure margins, potentially increasing prices slightly in the short term.
Regulatory and Policy Impact
- The FDA has approved several abbreviated new drug applications (ANDAs) for generic apomorphine formulations since 2021.
- Payer policies increasingly favor lower-cost generics, which could drive down prices.
- Biosimilar development remains slow due to the complexity of injectable formulations and patent protections.
Key Takeaways
- The drug associated with NDC 46122-0101 is Apomorphine Hydrochloride Injection for Parkinson's "off" episodes.
- The global market was approximately $250 million in 2022, dominated by the US.
- Price per vial hovers around $2,000-$2,500, with generics providing downward pricing pressure.
- Market growth remains modest, averaging 2-3% annually, with potential for pricing declines if generics gain traction.
- Policy and patent landscapes significantly influence future price trajectories.
FAQs
1. What factors influence apomorphine injection prices?
Manufacturing costs, regulatory approval processes, patent status, insurance reimbursement rates, and competition from generics drive pricing.
2. Is there a pipeline for biosimilars or new formulations?
Biosimilar development faces technical challenges; no major biosimilars for apomorphine have been approved as of 2023.
3. How does insurance impact patient access?
Most insurance plans cover a significant portion, but copay and prior authorization requirements can limit access.
4. What regional differences affect pricing?
In Europe, prices are generally lower due to regulatory and reimbursement differences; the US has higher prices driven by pricing policies.
5. Will patent expirations influence future prices?
Yes. Patent expirations, expected around 2024–2025, could allow for generic entries, reducing prices.
References
[1] IQVIA. “Market Analysis of Parkinson's Disease Medications 2022.” IQVIA Reports, 2022.
[2] FDA. “Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).” 2023.
[3] Global Data. “Parkinson’s Disease Market Forecast 2022–2027.” GlobalData, 2022.
[4] FDA. “ANDA Approvals for Apomorphine Formulations,” 2021–2023.
[5] Medicare and Health Insurance Reimbursement Data, 2023.
