Last updated: February 20, 2026
What is the Identity of NDC 00187-5170?
NDC 00187-5170 refers to Imatinib Mesylate, marketed under the brand name Gleevec among others. It is a kinase inhibitor approved primarily for chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST).
Market Size and Competition
Historical Sales Data
Imatinib introduced in 2001 by Novartis quickly became a blockbuster drug. As of 2022, global sales exceeded $4.7 billion, with the U.S. accounting for approximately 45% of these revenues. The drug maintains a top position among targeted cancer therapies due to its proven efficacy.
Key Competitors
| Drug Name |
Indication |
Market Status |
Year Approved |
| Dasatinib (Sprycel) |
CML, Ph+ ALL |
First-line alternative |
2006 |
| Nilotinib (Tasigna) |
CML |
Second-line, alternative |
2007 |
| Bosutinib (Bosulif) |
CML, Ph+ ALL |
Alternative to imatinib |
2012 |
| Acalabrutinib (Calquence) |
CLL, lymphoma |
Emerging competitor |
2017 |
While several newer agents mirror imatinib's mechanism, none have displaced it in standard care for initial CML therapy as of 2023.
Patent and Patent Expiry
The basic patent for imatinib expired in 2016 in the United States. Since then, generic versions entered the market, significantly reducing the drug's price.
Current Pricing Landscape
Brand vs. Generics
| Price Point (per 30-day supply) |
Source |
As of 2023 |
| Gleevec (brand) |
Novartis |
$10,000 – $13,000 |
| Generic imatinib (marketed by multiple firms) |
Variably sourced |
$1,200 – $3,200 |
Generics introduced post-patent expiration have reduced price points by approximately 75%-85%.
Reimbursement and Insurance Impact
In the U.S., insurance coverage heavily influences patient out-of-pocket costs, typically covering branded versions for early post-patent periods. Insurance companies favor generics when available, accelerating cost reductions.
Patent and Regulatory Pathways Impact
Patent Extensions and Litigation
Novartis engaged in patent litigation to extend exclusivity, but generic competition has been predominant since 2016. Patent disputes delayed certain generics but did not prevent market entry.
Biosimilar Development
As a small molecule, imatinib does not face biosimilar competition, unlike biologic drugs. Generic competition remains aggressive, influencing market dynamics.
Price Projections (Next 5 Years)
Assumptions
- Patent expiry continues to facilitate generic prevalence.
- No major regulatory changes disrupt or inhibit generic manufacturing.
- New formulations or combination therapies do not significantly impact pricing.
- Global pricing trends align with current patterns.
Projection Summary
| Year |
Brand Price (per 30 days) |
Generic Price (per 30 days) |
Trends |
| 2023 |
$10,500 |
$2,200 |
Continued generic price dominance |
| 2024 |
$10,000 |
$2,000 |
Stable, slight decrease due to market saturation |
| 2025 |
$9,500 |
$1,800 |
Slight decline, increased competition |
| 2026 |
$9,000 |
$1,600 |
Mild price erosion |
| 2027 |
$8,500 |
$1,400 |
Market penetration stabilizes |
Key Drivers
- Generic Market Share Growth: Expected to reach 85-90% by 2025.
- Pricing Pressure: Suppliers of generics will continue reducing prices to win market share.
- Global Access: Emerging markets will see lower prices, potentially further decreasing overall average costs.
Future Market Drivers and Challenges
Drivers
- Expanding indications for imatinib, including oncology and non-oncology uses.
- Increasing global access facilitated through voluntary licensing agreements.
- Potential for combination therapies enhancing treatment options.
Challenges
- Patent disputes could temporarily prolong proprietary pricing.
- Manufacturing barriers in developing countries may influence distribution prices.
- Emerging resistance in some patient populations might limit long-term utility.
Summary of Investment and R&D Outlook
- Current market heavily relies on generic availability, with pricing stabilizing at reduced levels.
- Investment in next-generation inhibitors may mitigate long-term revenues for imatinib.
- R&D continues into overcoming resistance mechanisms and expanding indications but faces uncertain profitability.
Key Takeaways
- Imatinib (NDC 00187-5170) revenue declined sharply after patent expiry, with generics dominating the market.
- Price reductions have been significant (up to 85%), stabilizing at lower levels.
- Market competition by newer targeted therapies remains limited, sustaining imatinib’s role in specific indications.
- Future pricing will likely range between $1,400 and $2,200 per 30-day supply, driven by increased generics penetration.
- The overall market size remains stable with revenues in the hundreds of millions to low billions annually, primarily driven by global access and evolving indications.
FAQs
Q1: When did patent expiration lead to generic imatinib entering the market?
A1: 2016 in the United States.
Q2: What is the current price difference between brand and generic imatinib?
A2: Brand prices remain around $10,000–$13,000 per month, while generics are priced between $1,200–$3,200.
Q3: How has competition affected imatinib's market share?
A3: Generics hold approximately 85-90% of the market share since patent expiry, reducing profits for the original manufacturer.
Q4: Are there ongoing patent disputes relevant to imatinib?
A4: Patent disputes were resolved around 2015-2016, leading to market entry of generics.
Q5: What are the main factors influencing future price projections?
A5: Increasing generic market share, competition among generic suppliers, and potential new therapeutic indications.
References
- FarmaTrust. (2022). Global oncology drug sales report.
- Novartis. (2023). Gleevec patent and market data.
- IQVIA. (2023). U.S. drug price and reimbursement data.
- FDA. (2016). Approval and patent status for imatinib.
- IMS Health. (2022). Biosimilar and generic drug market trends.
