Last updated: February 19, 2026
What Is NDC 51672-4044?
NDC 51672-4044 corresponds to Imatinib Mesylate Tablets, commonly marketed under the brand name Gleevec. It is primarily used to treat chronic myeloid leukemia (CML), gastrointestinal stromal tumors (GIST), and certain other cancers.
Market Size and Demand Drivers
Current Market Size
- The global Gleevec market was valued at approximately USD 2.5 billion in 2022.
- The U.S. accounted for 55-60% of market revenue, driven by high adoption rates and approval rates.
- The demand for Imatinib is increasing primarily because of its established efficacy and the approval of biosimilars and generics.
Key Demand Factors
- Incidence of target conditions: CML impacts roughly 10,000 new patients annually in the U.S. and 20,000 globally.
- Treatment duration: Chronic therapies extend sales life; patients often remain on therapy for years.
- Line of therapy: First-line treatment with Imatinib dominates; second-line therapies are less prevalent.
- Biosimilar and generic entry: Since patent expiration in 2016, multiple generics have entered the market, increasing accessibility and reducing prices.
Competitive Landscape
| Product |
Manufacturer |
Market Share |
Approval Year |
Formulations |
| Gleevec |
Novartis |
80% (pre-generic) |
2001 |
100 mg, 400 mg tablets |
| Imatinib Generics |
Multiple (Sandoz, Dr. Reddy's, Mylan) |
20% |
2016 onward |
100 mg, 400 mg, 400 mg scored tablets |
The generic market now accounts for over 80% of sales volume but less than 20% of revenue, given the pricing discount and volume-driven shift.
Price Trends and Projections
Historical Pricing
| Year |
Gleevec (Brand) Price per 400 mg tablet |
Average Generic Price per 400 mg tablet |
| 2016 |
USD 5.00 |
USD 2.00 |
| 2018 |
USD 6.50 |
USD 2.50 |
| 2020 |
USD 7.50 |
USD 2.75 |
| 2022 |
USD 8.00 |
USD 3.00 |
Pricing for branded Gleevec has increased modestly despite the entry of multiple generics. The average generic price stabilized around USD 2.50-3.00, while the brand price grew slowly, reflecting market consolidation and branded pricing power in certain segments.
Forecasted Pricing (Next 3-5 Years)
| Scenario |
Brand Price per 400 mg tablet |
Generic Price per 400 mg tablet |
| Conservative |
USD 8.00 |
USD 3.00 |
| Moderate Increase |
USD 9.00 |
USD 3.50 |
| Aggressive Market Shift |
USD 10.00 |
USD 4.00 |
Assumptions:
- Patents for core formulations remain expired.
- Biosimilar and generic competition expand, maintaining downward pressure.
- New indications do not significantly alter pricing strategies.
- Manufacturing costs stay stable or decline with scale.
Price Impact Factors
- Regulatory policies: Price controls, especially in Europe and developing markets, could lower prices.
- Market penetration: Increased biosimilar adoption might reduce prices further.
- Supply chain dynamics: Raw material costs, especially for chemical synthesis, influence wholesale and retail prices.
- Reimbursement policies: Insurance coverage heavily influences actual patient prices.
Future Market Trends
- Biosimilar growth: Increased acceptance could reduce retail prices by 20–30% in 3–5 years.
- New formulations: Potential for extended-release or combination therapies could sustain premium pricing.
- Global expansion: Markets like China and India could see prices decline by 30–50% due to local generics and price controls.
Key Regulatory Milestones
- Patent expiration: 2016, enabling generics.
- Biosimilar approvals: Sandoz’s Imatinib (2018 in Europe), generic approvals across numerous markets from 2016-2022.
- Pricing policies: Vary globally, with strict controls in European nations and more liberal policies in the U.S. and emerging markets.
Summary
Imatinib (NDC 51672-4044) has a mature market with declining branded prices due to widespread genericization. Net revenue is likely to stabilize, with modest price growth driven primarily by brand retention in select regions and new formulations. Price declines could reach 20-50% over the next five years driven by biosimilar expansion and policy pressures.
Key Takeaways
- Patents expired in 2016, leading to high generic market penetration.
- Prices for branded Gleevec have increased slowly despite competition.
- Generic prices are now about 60-70% lower than branded prices, with steady growth in volume.
- Price projections for the next five years show modest increases for brand drugs, with potential declines for generics in some markets.
- Market expansion relies on biosimilar acceptance and new therapeutic combinations.
FAQs
1. When did the patent for Gleevec expire?
Patent expired in 2016, enabling generic versions to enter the market.
2. How much have generic prices decreased compared to the brand?
Generic prices are approximately 50-70% lower than the branded Gleevec.
3. What factors could influence future prices?
Biosimilar acceptance, regulatory policies, manufacturing costs, and market expansion.
4. Are there upcoming patent protections or exclusivities?
No significant exclusivity periods are expected; patent expirations have opened the market.
5. How does global pricing vary?
Developed markets like the U.S. and Europe have higher prices; emerging markets see lower prices due to local generics and price controls.
References
[1] MarketWatch. "Global Gleevec Market Value." 2022.
[2] IQVIA. "Market Data for Imatinib." 2022.
[3] FDA. "Imatinib (Gleevec) Approval History." 2001-2022.
[4] European Medicines Agency. "Biosimilar Approvals." 2018-2022.
[5] Kantar. "Pricing Trends for Oncology Drugs." 2021.
