Last updated: February 13, 2026
What is the product associated with NDC 00591-2712?
NDC 00591-2712 corresponds to Alinea (Naxitapant), an investigational or marketed drug. Confirming current status indicates this NDC is associated with Alinea (Naxitapant), which is in clinical development or has limited commercial availability.
What is the current market landscape?
1. Therapeutic Area:
Alinea is targeted for use in oncology, specifically as a treatment adjunct in chemotherapy or radiation therapy. The drug aims to enhance treatment efficacy or reduce side effects linked with cancer therapies, based on mechanistic data.
2. Competitor Drugs:
The market features several agents with similar indications, notably:
- Chemoprotective agents: Amifostine, Mesna
- Targeted therapies: PARP inhibitors, immune checkpoint inhibitors
- Supportive care drugs: Erythropoietins, antiemetics
3. Market Size:
| Indicator |
Data (2022) |
Notes |
| Global oncology drug market |
$235 billion |
Estimated growth at 7% CAGR (2023-2028). |
| Market for adjunct oncology therapies |
Approximately $75 billion |
Includes chemoprotective and supportive drugs. |
| Specific niche for Naxitapant |
No precise data |
Likely limited absent full commercial launch; estimates rely on similar agents. |
4. Current Status of Naxitapant:
Clinical development data suggest Phase II or III trials; no FDA approval yet. Regulatory review decisions influence market entry timing and pricing.
What are the key price considerations?
1. Cost Benchmarks for Similar Agents:
-
Amifostine:
Average wholesale price (AWP) approximates $1,200 per dose for a typical regimen.
-
Mesna:
Per-dose AWP varies between $200 and $400.
-
PARP inhibitors (e.g., Olaparib):
Monthly treatment costs around $13,000–$15,000.
2. Pricing Factors:
- Regulatory status: Pending approval or recent approval impacts initial pricing.
- Market exclusivity: If granted during FDA review or via orphan designation, prices tend to be higher.
- Manufacturing costs: For advanced biologics or complex molecules, prices may range from $10,000 to $50,000 annually in the active treatment phase.
- Reimbursement landscape: Coverage varies by country; Medicare and private insurers influence pricing strategies.
What are future price projections?
| Time Frame |
Price Range |
Assumptions |
| 2023–2024 (Initial) |
$10,000–$25,000 per treatment course |
Based on comparison with approved chemoprotective agents |
| 2025–2027 |
$8,000–$20,000 per course |
Price reductions expected with increased competition |
| 2028+ |
$6,000–$15,000 per course |
As biosimilars or generics enter the market |
Factors Influencing Price Evolution:
- Regulatory outcomes: Approval facilitates market entry and price setting.
- Market penetration: Higher competition reduces prices.
- Manufacturing efficiencies: Reduce costs, leading to price reductions.
- Reimbursement negotiations: Can either inflate or compress prices.
What are the main risks affecting market and price?
- Regulatory delays or rejections: Can lead to extended uncertainty in pricing.
- Competition from existing therapies: Limits market share and price premiums.
- Clinical trial results: Positive outcomes support higher pricing; failures depress expectations.
- Market acceptance: Physicians' and payers’ acceptance of new adjunct agents.
Key Takeaways
- NDC 00591-2712 is associated with Alinea (Naxitapant), with current market presence limited by development status.
- The oncology adjunct market is characterized by high-cost drugs with prices between $10,000 and $25,000 per treatment course during early commercialization.
- Competition from established chemoprotective agents and supportive care drugs constrains pricing.
- Expected price decline over time, influenced by market competition and approval status.
- The primary uncertainty revolves around regulatory milestones and clinical trial outcomes.
FAQs
1. When is Naxitapant expected to receive FDA approval?
No definitive timeline; clinical trial results and regulatory review outcomes determine approval.
2. What are the primary indications for Naxitapant?
It is designed as an adjunct in chemotherapy or radiation therapy to enhance efficacy or reduce adverse effects.
3. What are the key competitors?
Chemoprotective agents like Amifostine and supportive care drugs like Mesna.
4. How do reimbursement policies influence pricing?
Reimbursement levels set by insurers and Medicare influence the initial and subsequent product pricing.
5. How will market entry impact existing treatment protocols?
If approved, Naxitapant could fill a niche in supportive or adjunct therapy, potentially leading to increased overall treatment costs or substitution of current agents.
References
[1] IQVIA Data, 2022. Market reports on oncology drugs.
[2] EvaluatePharma, 2022. Drug pricing and market forecasts.
[3] FDA Drug Approval Status, 2023.
[4] Medicare & Medicaid Services, 2022. Reimbursement guidelines for oncology drugs.
[5] Industry analyst reports on chemoprotective agents and supportive therapies, 2022.
