Last updated: February 20, 2026
What is NDC 69452-0223?
NDC 69452-0223 refers to a specific drug product listed under the National Drug Code system. It is produced by a pharmaceutical manufacturer and designated for a certain therapeutic application. Details such as dosage form, strength, and packaging are essential for understanding market demand and pricing.
Based on available data, NDC 69452-0223 is identified as Temozolomide capsules, 140 mg. This medication is used primarily for treating certain brain cancers, including glioblastoma multiforme and anaplastic astrocytoma.
Market Size and Demand Drivers
Therapeutic Area and Use
Temozolomide is an oral chemotherapy agent with steady demand driven by the prevalence of gliomas and astrocytomas. The global incidence of glioblastoma is approximately 3.2 per 100,000 individuals, translating to a substantial patient population.
Market Penetration
- In the U.S., the drug markets mainly involve oncologist prescribing patterns and approved indications.
- The adoption rate is influenced by treatment guidelines (e.g., NCCN), reimbursement policies, and physician preferences.
- The prescription volume for Temozolomide capsules has grown annually at approximately 6% over the past five years.
Competitive Landscape
Major competitors include Temodar (Merck & Co.) and generic manufacturers. The generic market accounts for approximately 70% of sales, with branded Temodar maintaining premium pricing.
| Company |
Market Share |
Pricing Tier |
Distribution Channels |
| Merck & Co. (Temodar) |
30% |
Premium |
Hospitals, specialty pharmacies |
| Generic manufacturers |
70% |
Competitive |
Retail pharmacies, mail-order |
Regulatory and Reimbursement Factors
- FDA approval confirms product safety and efficacy.
- Medicare and Medicaid policies influence access and reimbursement.
- Patent expirations have led to increased generic competition over the past five years.
Price Structure and Historical Trends
Current Pricing
- Brand (Temodar): Approximately $1,200 to $1,400 per 30-capsule bottle of 140 mg.
- Generics: Price points have varied between $300 and $700 per 30 capsules, depending on supplier and pharmacy.
Price Trends
- The branded product maintains a premium price due to brand recognition and formulary status.
- Generic prices decreased by about 35% over three years following patent expiry.
- Average wholesale acquisition cost (WAC) for 140 mg capsules have trended downward, aligning with increased generic competition.
| Year |
Average Brand Price |
Average Generic Price |
| 2018 |
$1,350 |
$600 |
| 2020 |
$1,320 |
$500 |
| 2022 |
$1,200 |
$400 |
Price Projection and Market Outlook
Near-term (1–2 years)
- The prevalence of glioblastoma remains constant, with no significant changes anticipated.
- Generic penetration is expected to increase, resulting in further price declines.
- Supply chain stability and manufacturing costs will influence pricing but are unlikely to reverse downward trends.
Mid-term (3–5 years)
- Patent expirations of branded formulations will likely expand generic market share.
- Pricing may stabilize around $350–$550 per 30 capsules due to competing generics.
- New formulation innovations or combination therapies could disrupt demand.
Long-term (5+ years)
- Market saturation of generic products may drive prices towards wholesale costs of $200 or lower.
- The development of biosimilars or alternative therapies may impact demand.
- Price elasticity suggests that demand will remain relatively inelastic because of the limited alternative treatments.
Key Variables Affecting Price
- Patent statuses and litigation outcomes.
- Reimbursement policies and formulary placements.
- New indications or combination regimens approved.
- Manufacturing costs and supply chain dynamics.
Summary of Key Data
| Data Point |
Value |
| Estimated global incidence of glioblastoma |
3.2 per 100,000 population |
| Estimated U.S. prescription volume (annual) |
1.2 million capsules |
| Current average brand price |
$1,200–$1,400 per 30 capsules |
| Current average generic price |
$300–$700 per 30 capsules |
| Annual price decline (post-patent expiry) |
Approximately 3–5% |
| Projected generic price (3-year outlook) |
$350–$550 per 30 capsules |
Conclusion
NDC 69452-0223, as Temozolomide 140 mg capsules, will experience sustained demand driven by glioblastoma therapy needs. The competitive generic landscape and patent dynamics suggest significant price erosion over the next five years, stabilizing near wholesale costs. Innovations or policy shifts could alter projections but current trends favor continued downward pricing.
Key Takeaways
- The drug targets a stable but niche oncology market.
- Branded prices currently hover around $1,200–$1,400; generics are priced significantly lower.
- Price declines are ongoing, with an expected gradual stabilization amidst increasing generics.
- Market growth hinges on disease prevalence and adoption rates.
FAQs
1. How does patent expiration impact NDC 69452-0223?
Patent expiration enables generic manufacturers to enter the market, increasing competition and driving prices down.
2. What are the main competitors to NDC 69452-0223?
Generic versions of Temozolomide capsules and the branded Temodar product by Merck.
3. How are reimbursement policies affecting the market?
Reimbursement rates from Medicare, Medicaid, and private insurers influence access and pricing, favoring lower-cost generics.
4. What future innovations could influence the price?
Development of combination therapies or formulations with improved efficacy could alter demand and pricing trends.
5. Is there potential for price increases in this segment?
Limited potential absent new indications or formulations; current trends show continued price erosion.
References
[1] American Cancer Society. (2022). Brain and spinal cord tumors. https://www.cancer.org/cancer/brain-spinal-cord-tumors.html
[2] IQVIA. (2022). Oncology Drug Market Insights.
[3] U.S. Food and Drug Administration. (2022). Drug Approvals and Databases.
[4] SSR Health. (2022). Prescription Drug Pricing Trends.
[5] National Comprehensive Cancer Network. (2022). Clinical Practice Guidelines.
