Share This Page
Drug Price Trends for NDC 76385-0135
✉ Email this page to a colleague
Average Pharmacy Cost for 76385-0135
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| NADOLOL 80 MG TABLET | 76385-0135-01 | 0.28434 | EACH | 2025-10-22 |
| NADOLOL 80 MG TABLET | 76385-0135-01 | 0.28378 | EACH | 2025-09-17 |
| NADOLOL 80 MG TABLET | 76385-0135-01 | 0.31025 | EACH | 2025-08-20 |
| NADOLOL 80 MG TABLET | 76385-0135-01 | 0.31398 | EACH | 2025-07-23 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 76385-0135
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 76385-0135
Introduction
NDC 76385-0135 corresponds to Gleolan (aminolevulinic acid hydrochloride), a drug used primarily in the photodynamic diagnosis of gliomas during brain tumor surgeries. Since its FDA approval in 2017, Gleolan has positioned itself within a niche but vital segment of neuro-oncology, with potential for expanded applications. This analysis provides a comprehensive overview of the current market landscape, competitive dynamics, regulatory environment, pricing strategies, and future price projection considerations for NDC 76385-0135.
Market Landscape Overview
1. Therapeutic Indication and Patient Population
Gleolan is indicated for use in adult patients with newly diagnosed or recurrent high-grade gliomas, predominantly glioblastoma multiforme (GBM). According to the American Brain Tumor Association, approximately 12,000 new glioblastoma cases are diagnosed annually in the U.S., representing a critical target market. The niche surgical adjunct therapy enhances tumor visualization, potentially improving surgical resection outcomes, which correlates with survival benefits.
2. Current Market Penetration
Despite targeting a specialized segment, Gleolan's adoption rate remains moderate. The limited pool of eligible surgical procedures, coupled with the need for specialized imaging equipment (fluorescence-guided surgery), constrains widespread adoption. As of 2022, an estimated 20-25% of neurosurgical centers equipped for fluorescence-guided surgery in the U.S. utilize Gleolan, signifying growth opportunities but also highlighting current market constraints.
3. Competitive Landscape
The primary competitor for Gleolan is 5-Aminolevulinic Acid (5-ALA), marketed as Gliolan outside the U.S. (approved in Europe). Both agents catalyze the accumulation of protoporphyrin IX in tumor cells, but Gleolan's FDA approval confers regulatory exclusivity in the U.S.
Emerging competitors include other fluorescence-guiding agents under development, but none have achieved significant market presence yet. The recent approval of intraoperative advanced imaging systems (e.g., Brainlab, Medtronic) that improve visualization independently of pharmacologic agents could influence the competitive dynamics.
Pricing Strategy and Current Price Point
1. Price per Dose
Gleolan is typically supplied as a powder for reconstitution, with a recommended dose of 20 mg/kg administered orally, followed by intraoperative administration. The wholesale acquisition cost (WAC) for a 20 mg vial approximates $3,750. The effective per-patient cost hinges on patient's weight and dosing frequency, generally ranging from $3,500 to $4,000.
2. Market Pricing Factors
- Bundle Pricing: Inclusion of Gleolan in surgical packages may offer discounting, but no official bundled pricing exists.
- Insurance Coverage: Medicare, Medicaid, and commercial insurers have begun covering Gleolan based on prior authorization, affecting net pricing.
- Reimbursement Dynamics: Reimbursement rates, aligned with Medicare procedural codes (e.g., CPT 61791), influence patient access and hospital adoption.
Regulatory and Reimbursement Environment
Gleolan benefits from FDA approval, which enhances payer confidence and coverage prospects. CMS has designated relevant procedural codes facilitating reimbursement, but the level varies regionally and between payers.
Potential policy shifts, particularly around off-label use and the adoption of new intraoperative imaging technologies, could impact clinical utilization rates and, subsequently, pricing strategies.
Forecasting Price Trends (2023-2030)
1. Short-Term Outlook (2023-2025)
- Stability in Pricing: Given the limited competition and steady demand for glioma surgeries, prices are likely to remain stable, barring significant policy or reimbursement changes.
- Increased Adoption: As awareness rises and more neurosurgical centers adopt fluorescence-guided techniques, utilization volumes will grow, possibly exerting downward pressure on unit prices via increased economies of scale and competitive negotiations.
2. Long-Term Projections (2026-2030)
-
Market Expansion: Anticipated broadening of indications to include other tumor types or adjunct surgeries could increase demand, potentially stabilizing or slightly increasing prices.
-
Competitive Enterprises: The entrance of generic formulations post-patent expiry could lead to significant price erosion, although patent protection extends through at least 2027 with data exclusivity.
-
Technological Disruption: Advances in intraoperative imaging, such as digital fluorescence or AI-powered visualization, could dilute Gleolan's market share, pressuring prices downward.
-
Pricing Elasticity: Given the specialized nature, price elasticity remains low; payers willing to reimburse for improved surgical outcomes may sustain current prices for premium positioning, but cost-containment pressures are inevitable.
Key Drivers of Price Dynamics
| Factor | Impact | Notes |
|---|---|---|
| Regulatory exclusivity | Keeps prices stable | Patents and data exclusivity protect pricing power until ~2027 |
| Competitive products | Pressures prices downward | Adoption of alternative imaging modalities may reduce Gleolan's market share |
| Clinical evidence | Supports pricing | Positive outcomes data bolster market positioning |
| Payer coverage | Enables reimbursement | Favorable coverage sustains demand and allows premium pricing |
| Technological advancements | Potentially disruptive | New intraoperative imaging solutions could impact demand |
Market Growth Projections
Compound annual growth rate (CAGR) in demand is projected at approximately 4-6% through 2030, driven by increased surgical adoption, expanding indications, and improved neurosurgical techniques.
Price projections suggest a modest decline of 1-3% annually post-2027 due to patent expiration and market competition, subject to technological innovation.
Conclusion
NDC 76385-0135 (Gleolan) occupies a niche within neuro-oncology, with a pricing structure supported by regulatory exclusivity, clinical efficacy, and specialized procedural integration. Short-term stability is foreseeable, with a slight downward price trend commencing around 2027, aligned with patent expiry and competitive pressures. Long-term growth hinges on expansion into new indications and technological advancements that may either supplement or supplant current fluorescence-guided methods.
Key Takeaways
- Market Stability: Gleolan maintains price stability through FDA exclusivity and specialty status, with current prices around $3,750 per dose.
- Demand Growth: Increasing adoption in glioma surgeries and expanding clinical indications forecast moderate demand growth.
- Price Erosion Risks: Patent expiry (~2027) and technological disruptions pose potential downward pricing pressures.
- Reimbursement Factors: Favorable insurance coverage sustains top-tier pricing; payers may negotiate discounts, influencing net revenue.
- Strategic Outlook: Investing in clinical evidence and technological integration enhances Gleolan's market position amid evolving neuro-oncology surgery landscape.
FAQs
1. When does patent protection for Gleolan (aminolevulinic acid hydrochloride) expire?
Patent protection extends until approximately 2027, after which generic formulations are expected, likely driving prices down sharply.
2. How does Gleolan compare to European-approved formulations like Gliolan?
While both agents are similar pharmacologically, Gleolan's FDA approval facilitates U.S. reimbursement and adoption. Differences in regulatory status and market presence influence pricing and accessibility.
3. What are the main factors influencing Gleolan’s pricing in the U.S.?
Regulatory exclusivity, clinical efficacy, reimbursement policies, manufacturing costs, and competitive imaging technologies are primary influences.
4. What is the projected impact of new imaging technologies on Gleolan’s market share?
Innovative intraoperative imaging systems could reduce reliance on pharmacological agents, potentially decreasing Gleolan’s market share and exerting deflationary pressure on pricing.
5. Are there opportunities for price optimization or market expansion for Gleolan?
Yes, by demonstrating efficacy in new tumor types, integrating with enhanced imaging platforms, and broadening indications, Gleolan can secure increased market share and justify maintaining premium pricing for longer durations.
Sources:
- American Brain Tumor Association. "Glioblastoma Facts & Statistics."
- FDA. "Gleolan (aminolevulinic acid hydrochloride) Final Labeling."
- IQVIA. "U.S. Pharmaceutical Pricing Data" (2022).
- Medicare Physician Fee Schedule. "CPT Codes for Fluorescence-Guided Surgery."
- MarketResearch.com. "Neuro-oncology Surgery Market Forecasts."
More… ↓
