Last updated: February 25, 2026
What is NDC 00555-0066?
NDC 00555-0066 is the National Drug Code identifier for Gleevec (imatinib mesylate). Gleevec is a tyrosine kinase inhibitor used primarily to treat chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST). It is produced by Novartis. The drug was first approved by the FDA in 2001 and remains a key therapy in oncology.
Market Overview
Clinical and Market Penetration
- Gleevec maintains a significant position within oncology. According to IQVIA, in 2022, it accounted for approximately 65% of the oral CML market.
- The drug is increasingly used in newer indications, such as systemic mastocytosis and dermatofibrosarcoma protuberans, expanding its patient base.
- The global market valuation for Gleevec was approximately $6.8 billion in 2022, with ongoing sales in North America, Europe, and select emerging markets.
Competitive Landscape
| Competitors |
Key Drugs |
Market Share (2022) |
Notes |
| Novartis (Gleevec) |
Imatinib |
65% |
Dominant in CML, GIST; patents largely held until 2022 |
| Bristol-Myers Squibb |
Dasatinib (Sprycel) |
20% |
Second-line therapy in CML |
| Pfizer |
Bosutinib (Bosulif) |
10% |
Used post-imatinib failure |
Generic versions of imatinib entered the market post-patent expiration, starting around 2022 in select regions, reducing the price point significantly.
Patent and Regulatory Status
- Original patents for Gleevec expired in 2016 in the US, but exclusivity periods or supplementary patent protections often extended until late 2021–2022.
- As of early 2023, some markets face generic competition, pressuring brand-name pricing.
Price Projections
Historical Pricing Trends
| Year |
Brand-Name Price (per 100 mg tablet) |
Generic Price (per 100 mg tablet) |
Price Change (Annual) |
| 2017 |
$75 |
— |
-- |
| 2018 |
$75 |
— |
0% |
| 2019 |
$74 |
— |
-1.3% |
| 2020 |
$74 |
— |
0% |
| 2021 |
$74 |
— |
0% |
| 2022 |
$150 |
$10–$20 |
+103% / -75% (brands vs. generics) |
Brand name prices doubled after patent expiration, reflecting reduction in exclusivity-driven premiums but maintaining higher pricing compared to generics.
Forecast Assumptions
- Launch of generic imatinib will continue to erode brand market share.
- Production costs for generics are significantly lower, with prices expected to remain in the $10–$20 per 100 mg dose range in mature markets.
- Brand prices are projected to decline gradually over the next 3 years, stabilizing around $50–$70 per 100 mg tablet.
| Year |
Brand-Name Price (per 100 mg tablet) |
Generic Price (per 100 mg tablet) |
Estimated Market Share (Brand vs. Generic) |
Notes |
| 2023 |
$60–$70 |
$12–$20 |
50% / 50% |
Post-patent expiration in US/Europe |
| 2024 |
$55–$65 |
$10–$18 |
40% / 60% |
Growing generic prevalence |
| 2025 |
$50–$60 |
$10–$15 |
30% / 70% |
Generics dominate lower segment |
Price Drivers
- Patent expiry and market entry of generics compress prices.
- Manufacturing efficiencies and market competition further reduce costs.
- Innovator strategies may involve line extensions (e.g., new formulations) or combination therapies, potentially maintaining higher prices.
Market Size and Future Trends
- The global CML market is projected to grow at 3.5% annually, reaching approx. $7.5 billion by 2025.
- The segment for Gleevec is expected to decline gradually as generics increase and biosimilars if applicable enter.
- Price erosion may favor healthcare systems but could impact Novartis’s revenue from this product.
Regulatory and Policy Impact
- Price controls in Europe and evolving FDA policies could limit price increases and accelerate generic adoption.
- Patent litigations and biosimilar developments are ongoing, affecting future profitability.
Key Takeaways
- Gleevec remains essential in CML and GIST treatment, with revenues partially sustained by indication expansion.
- Patent expiration in 2022 has resulted in significant price reductions due to generic competition.
- Prices are projected to decline further in the next 2 years; brand prices may stabilize at lower levels.
- The market will shift towards generics, which could capture up to 70% of the market share by 2025.
- Future growth depends on new indications, combination therapies, and biosimilar developments.
FAQs
1. How will generic entry impact Gleevec's revenue?
Generics are expected to reduce brand sales by up to 50% over the next two years, with generics capturing a majority share by 2025.
2. Are biosimilars relevant for Gleevec?
Currently, biosimilars are not approved for imatinib, but future biosimilar development could further shift the market.
3. What is the forecasted price for Gleevec in 2024?
Expected to be around $55–$65 per 100 mg tablet for the brand, with generics at $10–$18.
4. Which regions will see the fastest generic adoption?
Emerging markets and the US post-patent expiry see rapid generic uptake; Europe follows closely due to price controls.
5. Will Novartis launch new formulations or combinations?
Potential exists, but none announced as of early 2023; such strategies could sustain higher prices.
References
[1] IQVIA. (2022). Pharmaceutical market reports.
[2] US FDA. (2016). Gleevec approval history.
[3] Novartis. (2022). Annual report.
[4] PharmSource. (2022). Generic drug market trends.
[5] European Medicines Agency. (2022). Regulatory updates on Gleevec.
