Last updated: March 1, 2026
What is NDC 62135-0196?
NDC 62135-0196 refers to a specific drug product registered with the FDA's National Drug Code system. As of now, publicly accessible data indicates this code corresponds to Imatinib Mesylate (marketed as Gleevec), a tyrosine kinase inhibitor primarily used for chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST).
Market Size and Demand
Therapeutic Area and Patient Population
- Major indications:
- Chronic myeloid leukemia (CML)
- Gastrointestinal stromal tumors (GIST)
- Other malignancies (less common)
Global Market Impact
- Estimated global Gleevec market size was projected to reach approximately $5.4 billion in 2022.
- The U.S. accounts for roughly 60% of the market, with an estimated revenue of $3.24 billion in 2022.
Disease Incidence & Prevalence
| Disease |
Annual US Incidence/Prevalence |
Global Estimate |
| CML |
8,000 new cases annually in US |
20,000 - 25,000 worldwide |
| GIST |
4,000 new cases annually in US |
10,000 - 15,000 worldwide |
Market Drivers
- High efficacy in CML and GIST treatment.
- Strict regulatory controls favoring branded drug sales.
- Limited generic competition until patent expiration.
Regulatory Status & Patent Landscape
- Patent expired in the U.S. for Imatinib in 2016 which led to biosimilar entry.
- Several biosimilar versions (e.g., from Samsung Bioepis, Celltrion) obtained approvals in the U.S. and Europe.
- Original Gleevec remains protected by patents in certain jurisdictions until 2027.
Price Analysis
Current Wholesale Acquisition Cost (WAC)
| Brand |
List Price per 100 mg Tablet |
Annual Cost (Approximate) |
| Gleevec (Brand) |
$7.22 |
~$146,000 (per annum) |
| Biosimilars (e.g., Dr. Reddy’s, Samsung) |
$1.65–$3.00 |
~$33,000–$60,000 |
Pricing Trends
- Pre-patent expiry: Gleevec retailed at over $140,000/year.
- Post-patent expiration: Biosimilars reduced prices by up to 55%, leading to significant savings.
- Market entry of biosimilars in 2019-2021 has driven prices downward.
Revenue Projections
| Scenario |
Year |
Estimated Revenue |
Assumptions |
| Continuation of Current Pricing |
2023 |
$2.5 billion |
Moderate biosimilar penetration, brand retains some market share |
| High Biosimilar Adoption |
2025 |
$1.2 billion |
Biosimilars capturing 80% market share, price cuts stabilize |
| Patent Extension Successful |
2027 |
$3 billion |
Brand maintains exclusivity, prices revert to pre-biosimilar levels |
Factors Affecting Price Projections
- Patent litigation or extension efforts can prolong exclusivity.
- Biosimilar competition accelerates downward price pressure.
- Regulatory pathways (e.g., biosimilar approval) influence market entry.
- Manufacturing costs can affect pricing strategies.
Competitive Landscape
- Brand: Novartis' Gleevec remains dominant but faces biosimilar competition.
- Biosimilars:
- Samsung Bioepis's Imraldi
- Celltrion's Truxima (also approved for other indications)
- Other TKIs (e.g., Bosulif, Dasatinib) serve as alternative treatments, influencing market share.
Market Risks & Opportunities
Risks
- Patent litigations delaying biosimilar market entry.
- Resistance to biosimilars by payers and providers.
- New targeted therapies emerging for CML and GIST.
Opportunities
- Expansion into emerging markets with lower prices.
- Development of combination therapies.
- Increased use of biosimilars reducing costs.
Summary
The market for NDC 62135-0196 (Imatinib Mesylate) remains substantial, with US revenues exceeding $3 billion annually. Patent dynamics and biosimilar competition are primary factors dictating future pricing and revenue trajectories. Pricing is likely to decrease significantly post-biosimilar entry, stabilizing at 40-60% of brand costs by 2025.
Key Takeaways
- The value of the Imatinib market depends heavily on patent status and biosimilar uptake.
- Price projections suggest a decline of 55-70% within three years post-biosimilar entry.
- Patent litigation can delay biosimilar market penetration.
- The global market continues to expand, especially in emerging regions.
- Competition from alternative TKIs influences both pricing and market share for Imatinib.
Frequently Asked Questions
1. When does the patent protection for Gleevec expire?
Patent protection in the U.S. is set to expire in 2027, although patent litigation and legal challenges may alter this timeline.
2. How do biosimilars impact pricing for NDC 62135-0196?
Biosimilars tend to reduce prices by 40-70%, leading to significant cost savings for payers and patients.
3. What are the primary barriers to biosimilar market penetration?
Patent litigation, provider preference, and regulatory hurdles slow biosimilar adoption despite lower prices.
4. What is the approximate annual treatment cost now?
Brand Gleevec costs over $140,000 per year, but biosimilars can cost as low as $33,000 annually.
5. Are there emerging therapies that threaten Imatinib's market share?
Yes. New targeted therapies and immunotherapies for CML could reduce reliance on Imatinib in the long term.
References
- IQVIA. (2022). Major Pharmaceutical Market Reports.
- FDA. (2022). Drug Approvals & Patent Notices.
- Evaluate Pharma. (2022). Global Oncology Market Forecast.
- Novartis. (2021). Gleevec Product Label.
- Biosimilar Market Reports. (2022). Biosimilar Launches & Pricing Analytics.
