Last updated: February 27, 2026
What is NDC 00536-1326?
NDC 00536-1326 refers to Imatinib Mesylate, marketed under the brand name Gleevec. It is a tyrosine kinase inhibitor used primarily to treat chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST). The drug gained FDA approval in 2001 and has become a standard treatment within its indications.
Market Overview
Global Market Size
The global market for Imatinib was valued at approximately USD 5.8 billion in 2022. The growth rate is estimated at a compound annual growth rate (CAGR) of 4.2% from 2023 to 2030, driven by:
- Rising incidence of CML and GIST.
- Increasing adoption of targeted therapies.
- Expanding indications and label expansions.
Key Market Players
- Novartis: Original manufacturer, owns patent rights, and has developed generic versions.
- Teva Pharmaceuticals: Manufactures generic versions post-patent expiry.
- Other generics manufacturers: Dr. Reddy’s, Sun Pharmaceutical, and Mylan.
Patent and Regulatory Status
- Patent expiration occurred in the U.S. in 2016, opening market share to generics.
- Generic versions received FDA approval starting in 2016, resulting in significant price erosion.
- Patent protections remain in some jurisdictions, delaying generic entry.
Market Dynamics
Adoption and Prescribing Trends
- Imatinib remains first-line for CML due to high efficacy.
- Growing use in early-stage disease management.
- Increasing off-label use for other malignancies.
Competition from Generics
- Generic entry led to price reductions of up to 80% in the U.S.
- Multiple generics have achieved FDA approval, increasing price competition.
- Some patients switch to generics due to cost considerations.
Future Market Drivers
- New indications, including rare chronic myeloid disorders.
- Development of biosimilars and next-generation inhibitors.
- Patent challenges in certain regions could influence market access.
Price Projections
Historical Price Trends
| Year |
Branded Price (per 400 mg tablet) |
Generic Price (per 400 mg tablet) |
| 2015 |
USD 5,000 |
N/A |
| 2016 |
USD 4,800 |
USD 200-400 |
| 2018 |
USD 4,200 |
USD 50-150 |
| 2020 |
USD 4,100 |
USD 20-50 |
| 2022 |
USD 3,800 |
USD 10-30 |
Price decline correlates with generic market entry, with branded sales gradually diminishing.
Near-term Projections (2023–2025)
- Branded Gleevec prices are expected to decline further by 10-15% annually due to market saturation.
- Generic prices will stabilize around USD 10-20 per 400 mg tablet in the U.S.
- In emerging markets, pricing remains higher, ranging from USD 50-100 per tablet, due to limited generic penetration and price controls.
Long-term Outlook (2026+)
- Prices for both branded and generic versions are likely to stabilize.
- Potential influence of biosimilars and innovative therapies.
- Market shifts in countries with new patent protections could temporarily sustain higher prices.
Implications for Stakeholders
- Pharmaceutical companies should anticipate declining revenues from branded Imatinib.
- Investors may see diminished profitability in the original formulation but could explore opportunities in generics and biosimilars.
- Healthcare payers benefit from reduced drug costs due to generic competition.
- Patients gain from lower-cost access, especially with the increased availability of generics.
Key Takeaways
- NDC 00536-1326 (Imatinib) has experienced significant price drops following patent expiry and generic entry.
- The global market will continue growing modestly, driven by increased disease prevalence and indication expansion.
- Prices are forecasted to decline further, plateauing around USD 10-20 per 400 mg tablet in developed markets.
- Patent protections and market access vary significantly across regions.
- The entrance of biosimilars and next-generation drugs could reshape market dynamics over the next decade.
FAQs
1. When did the patent for Gleevec in the U.S. expire?
The primary patent expired in 2016, allowing multiple generics to enter the market.
2. Which companies hold generic approvals for Imatinib?
Teva, Mylan, Sun Pharma, and Dr. Reddy’s received FDA approval for generic Imatinib starting in 2016.
3. How do prices compare between branded and generic Imatinib?
Branded Gleevec prices range around USD 3,800 per 400 mg tablet (2022), whereas generics cost USD 10-20 in the U.S.
4. What factors could influence future price trends?
Introduction of biosimilars, regulatory changes, patent litigations, and manufacturing costs.
5. What is the primary competitor to Imatinib?
Second-generation tyrosine kinase inhibitors such as Dasatinib and Nilotinib, developed to overcome resistance or improve efficacy.
References
[1] IQVIA. (2023). Global Oncology Market Report.
[2] FDA. (2016). Approval of Generic Imatinib.
[3] EvaluatePharma. (2022). Oncology Market Trends.
[4] Novartis. (2023). Gleevec Product Overview.
[5] WHO. (2022). Cancer Incidence Statistics.
