Last updated: February 26, 2026
What is NDC 27808-0086?
NDC 27808-0086 refers to a specific drug product registered under the National Drug Code (NDC) system. While proprietary details are limited here, the NDC typically pertains to a branded or generic pharmaceutical used in clinical practice or commercial distribution.
Based on available data, NDC 27808-0086 corresponds to Gleolan (as of the latest updates), a formulation of aminolevulinic acid hydrochloride used for photodynamic therapy, primarily in treating gliomas.
What is the Current Market Environment?
Market Size and Sales Volume
Gleolan is a niche drug with targeted oncology indications. It received FDA approval in 2017 and is marketed by Maple Cross Oncology LLC, a subsidiary of Meda Pharma.
Key market points:
- Target patient population: Patients with newly diagnosed or recurrent gliomas.
- Estimated US sales (2022): Approximately $50 million.
- Distribution channels: Specialty oncology clinics, hospitals, and infusion centers.
Competition and Market Share
Gleolan faces competition from:
- Surgical resection (standard of care without a direct drug comparator)
- Other photodynamic agents or experimental therapies
As of 2022, Gleolan's market penetration remains moderate, with limited competition due to its specific indication and FDA approval for a niche segment.
Reimbursement and Pricing Dynamics
- Average wholesale price (AWP): Around $8,000–$10,000 per treatment course.
- Reimbursement landscape: Insured patients predominantly via Medicare, Medicaid, and commercial insurers, with Medicare part B coverage for injectable drugs.
Price Projections
Factors Influencing Price Trends
- Regulatory updates: Any FDA labeling or approval changes could impact pricing.
- Market penetration: Increasing adoption in neurosurgical centers can support price stability or increases.
- Competitive pressures: Introduction of new therapies could moderate prices.
- Manufacturing costs: Raw material prices for aminolevulinic acid and packaging may influence wholesale prices.
Short-Term (1–2 years)
- Price stability expected: No significant price fluctuations anticipated due to limited competition.
- Average wholesale price (AWP) likely to remain in the $8,000–$10,000 range per treatment course.
Medium Term (3–5 years)
- Potential for modest increase: A 2–4% annual increase may occur, driven by inflation and demand growth.
- Market expansion: Higher adoption across treatment centers can support pricing power.
- New indications: If approved for additional indications, price premiums may be justified.
Long-Term (5+ years)
- Price plateau or decline: Entry of biosimilars or generics could drive prices down.
- Market erosion factors: Development of novel therapies with better efficacy may reduce demand.
| Year |
Estimated Price Range (per treatment course) |
Notes |
| 2023 |
$8,000–$10,000 |
Current pricing, stable market launch |
| 2024–2025 |
$8,160–$10,400 (assuming 2%–4% increase) |
Inflation and demand-driven adjustments |
| 2026–2028 |
Potential slight decline or stability |
Biosimilar entry possible; market stabilization |
Regulatory and Policy Impacts on Pricing
- FDA/Specialty Drug Incentives: As an oncology drug, efforts to promote access or reduce costs through policy changes could influence prices.
- Insurance Reimbursement Policies: Shifts towards value-based payments can pressure firms to reconsider pricing.
Summary
- NDC 27808-0086 (Gleolan) commands a stable price in the current context.
- Market growth remains limited but steady due to the niche indication.
- Future price increases are moderate, with potential declines if biosimilars or generics enter the market.
- Key drivers include adoption rate, regulatory actions, and competitive landscape.
Key Takeaways
- The drug's market value remains centered around $8,000–$10,000 per course.
- Growth in usage is expected to be gradual, with price pressure from potential biosimilar entry.
- Regulatory and reimbursement policies will influence long-term pricing dynamics.
FAQs
1. What factors could lead to a significant price increase for this drug?
A major expansion in approved indications, increased adoption, or regulatory changes favoring higher reimbursement could drive price increases.
2. How does competition influence the price of NDC 27808-0086?
Limited direct competitors currently support pricing stability. Introduction of biosimilars or new therapies would create downward pressure.
3. Are there any recent regulatory developments affecting the drug’s price?
No recent FDA label changes or new approvals are expected to significantly impact pricing presently.
4. What is the potential impact of biosimilars on this drug’s market?
Biosimilar competition can lead to prices declining by 20–40% over 3–5 years.
5. How does reimbursement policy influence the actual price paid by patients?
Reimbursement levels determine out-of-pocket costs and can cap the effective price for the healthcare system.
References
- U.S. Food and Drug Administration (FDA). (2017). FDA approval letter for Gleolan.
- IQVIA. (2022). Oncology drug market analysis.
- Meda Pharma. (2022). Gleolan product information.
- Centers for Medicare & Medicaid Services. (2022). Reimbursement policies for oncology drugs.
- Industry price reports. (2022). Wholesale acquisition cost analyses.
