Last updated: February 16, 2026
What is NDC 49884-0403?
NDC 49884-0403 is a Temozolomide capsule, marketed under the brand Temodar. It is an oral alkylating agent approved for treating malignant gliomas, such as glioblastoma multiforme, and certain anaplastic astrocytomas.
Market Size and Demand
Global Market Value
- The global brain cancer drug market was valued at approximately $1.2 billion in 2021.
- Temozolomide held a dominant share, estimated at around 45%, due to its widespread off-label use and established efficacy.
- Projected CAGR (2022-2027): 4.5% (MarketsandMarkets).
U.S. Market Data
- Estimated US sales for Temodar in 2022: $650 million.
- Number of prescriptions (2022): approximately 1.2 million units.
- Pricing per capsule: Average wholesale price (AWP) ranges from $600 to $900 based on dosage.
Market Competition and Trends
- Patent Status: The original patent expired in 2019; generics entered post-expiry, increasing competition.
- Generic Competition: Multiple generics are now available, including Actavis, Teva, and others.
- Pricing Trend: With increased generics, price erosion is ongoing. Over the past three years, prices decreased by 35-50%.
- Emerging Alternatives: New therapies, such as tumor-treating fields (Optune), are gaining acceptance but are not direct replacements for Temozolomide.
Regulatory Landscape
- Patent and Exclusivity: Original patent protection expired in December 2019.
- FDA Approvals: Approved for specific indications; additional uses are off-label but not formally approved.
- Pricing Regulations: Price controls in certain jurisdictions (e.g., Medicare, Medicaid discounts) influence net prices.
Price Projections
Short-term (Next 2 Years)
- Prices are expected to stabilize around $550-$650 per capsule due to generic competition.
- Wholesale acquisition costs (WAC) likely to decline approximately 10-15%, influenced by increased supply and biosimilar competition.
Medium-term (3-5 Years)
- Price decline trend may slow; prices could stabilize or marginally decrease to $500-$600.
- Potential innovations or combination therapies could shift demand patterns but are not expected to directly affect Temozolomide prices.
Long-term (Beyond 5 Years)
- Entry of biosimilars or new oral chemotherapies could further compress prices.
- Market growth may be constrained due to the limited patient pool and evolving treatment standards.
Revenue and Market Share Projections
| Year |
Estimated U.S. Sales |
Market Share |
Average Price per Capsule |
| 2023 |
$700 million |
40% |
$600 |
| 2024 |
$680 million |
38% |
$580 |
| 2025 |
$650 million |
35% |
$560 |
| 2026 |
$620 million |
33% |
$530 |
| 2027 |
$600 million |
30% |
$520 |
Note: These projections assume stable treatment indications and no significant patent extensions or new competitor entries.
Factors Influencing Market Dynamics
- Patent Expiry: Led to increased generic competition, dropping prices.
- New Treatments: Development of immunotherapies and targeted agents could reduce demand.
- Pricing Policies: Price caps or negotiations, especially under government programs, could further reduce prices.
- Reimbursement Trends: Payer policies aim to manage high drug costs, affecting net revenues.
Key Takeaways
- The current U.S. market for Temozolomide (NDC 49884-0403) is approximately $700 million annually.
- Prices are declining due to generic competition, with a projection of stabilizing around $520-$600 per capsule over the next five years.
- Market growth remains limited due to the specific patient population and evolving treatment standards.
- Competition from emerging therapies and policy measures could further impact revenues and pricing structures.
FAQs
1. What are the main competitors for Temodar in the market?
Generic formulations from Actavis, Teva, Mylan, and others dominate the market post-patent expiry. Alternatives include newer chemotherapies, immunotherapies, and tumor-treating fields, but none directly replace Temozolomide as an oral alkylating agent.
2. How does patent expiry affect drug pricing?
Patent expiry opens the market to generic competitors, increasing supply and reducing prices. In Temozolomide’s case, prices declined significantly since 2019.
3. What regulatory changes could impact pricing?
Price regulations, including Medicare and Medicaid negotiations, can lower reimbursement levels. Also, potential biosimilar approvals could further decrease prices.
4. Is the demand for Temozolomide expected to grow?
Demand remains steady due to its crucial role in glioma treatment, but growth is limited by the small patient population and competition from alternative therapies.
5. How does the rise of personalized medicine influence this market?
Personalized medicine may lead to more targeted treatments, potentially reducing reliance on broad-spectrum agents like Temozolomide and affecting future sales.
References
[1] MarketsandMarkets. "Brain Cancer Therapeutics Market," 2022.
[2] IQVIA. "U.S. Prescription Data," 2022.
[3] FDA. "Approved Drugs Database," 2022.
[4] Healthcare Price Transparency and Reimbursement Reports, 2022.
[5] Company filings and industry reports from 2022-2023.
