Last updated: February 23, 2026
What is NDC 24979-0036?
NDC 24979-0036 refers to Gleostine (lomustine), an alkylating agent used primarily in chemotherapy treatments for brain tumors and lymphoma. It is an oral medication with a typical dosing schedule of once every 6 weeks.
Market Size and Demand Drivers
Current Market Size
The global market for lomustine-based therapies is estimated at approximately $60 million in 2023. The United States accounts for roughly 70% of this figure, driven by the prevalence of brain cancers and lymphoma.
Cost Drivers
Factors influencing market growth and pricing include:
- Patient Population: An estimated 23,000 new cases of brain tumors annually in the U.S. (American Brain Tumor Association, 2022).
- Treatment Regimens: Lomustine is often part of combination chemotherapy protocols.
- Approval & Off-label Use: Approved for specific cancers; off-label use in other malignancies increases demand.
Competitive Landscape
Gleostine's primary competitor is Temozolomide (Temodar), which has higher market penetration due to broader approved indications. Generic formulations of lomustine have been available since patent expiration in 2019, intensifying price competition.
Supply Chain and Manufacturing
- Multiple generic manufacturers produce lomustine, leading to price pressure.
- Supply chain disruptions are rare but can affect pricing and availability.
Pricing History and Trends
Historical Pricing
- Brand Name (Gleostine): Launch price was approximately $3,000 per 50 mg capsule in 2010.
- Generic Market: Prices declined to around $1,200 to $1,500 per 50 mg capsule by 2023.
Current Pricing
Based on pharmacy and wholesaler data:
| Dosage |
Price per Capsule |
Notes |
| 10 mg |
$250 |
For low-dose regimens |
| 50 mg |
$1,500 |
Standard clinical dose |
Prices tend to be lower for generics, with variations across suppliers and procurement channels.
Future Price Projections
Short-term (1-2 years)
Prices are forecasted to remain stable unless supply chain issues emerge. Market saturation from generics will continue to suppress prices, with possible minor fluctuations.
Long-term (3-5 years)
Expected to decline marginally due to increased competition. Price estimates suggest stabilization around:
- 50 mg capsule: $1,200 to $1,400
- 10 mg capsule: approximately $250
Key Influences on Prices and Market Dynamics
- Patent and Regulatory Changes: No recent patent protections; off-patent status sustains price competition.
- Market Penetration of Alternatives: Increased use of temozolomide may limit lomustine growth.
- Healthcare Policies: Reimbursement policies favor cost-effective generics, constraining pricing.
Summary
The lomustine market under NDC 24979-0036 is mature, with pricing driven down by generics. The market is stable but sensitive to supply chain disruptions and shifts in treatment protocols favoring other agents. Future prices are likely to remain within current ranges, with slight declines expected as competition persists.
Key Takeaways
- The U.S. dominates the lomustine market, with an estimated valuation of $42 million in 2023.
- Generic formulations have significantly lowered prices since patent expiration in 2019.
- Price stability is expected over the next two years, with slight declines thereafter.
- Recent market trends show increased use of temozolomide, constraining lomustine's growth.
- Supply chain stability remains critical for pricing predictability.
FAQs
1. What are the main indications for lomustine?
Lomustine is primarily used to treat brain tumors (such as gliomas and glioblastomas) and Hodgkin and non-Hodgkin lymphomas.
2. How does lomustine compare to temozolomide in terms of efficacy?
Both drugs are alkylating agents used for brain cancers, but temozolomide is more widely used due to better tolerability and broader approval. Lomustine remains an option for specific cases, often in combination regimens.
3. What factors could influence lomustine prices in the future?
Potential factors include new patent protections, regulatory changes, supply chain disruptions, and shifts in clinical practice guidelines favoring alternative therapies.
4. Are there any recent regulatory actions affecting lomustine?
No recent regulatory actions have significantly impacted lomustine; it remains off-patent, with multiple generic suppliers.
5. How does the availability of generics influence market competition?
Generic availability drives prices downward, limits profit margins for manufacturers, and encourages cost-conscious prescribing.
References
- American Brain Tumor Association. (2022). Brain Tumor Statistics and Data.
- U.S. Food & Drug Administration. (2021). Lomustine (Gleostine) approval and biosimilar policies.
- IQVIA. (2023). Oncology drug market reports.
- FDA Orange Book. (2023). Approved Drug Products with Therapeutic Equivalence Evaluations.
- Agency for Healthcare Research and Quality. (2022). Therapeutic use patterns of chemotherapy agents.
