Last updated: February 22, 2026
What is NDC 51862-0643?
NDC 51862-0643 refers to Tasigna (nilotinib), an oncology medication approved by the FDA for the treatment of Chronic Myeloid Leukemia (CML) in adult patients. It functions as a tyrosine kinase inhibitor targeting BCR-ABL.
Market Overview
Current Market Size
- The global CML treatment market was valued at approximately $2.0 billion in 2022, with an expected compound annual growth rate (CAGR) of about 8% through 2030.[1]
- Tasigna accounts for roughly 20% of the market share among second-generation BCR-ABL inhibitors, competing primarily with Gleevec (imatinib) and Sprycel (dasatinib).[2]
- In the U.S., approximately 8,000 new cases of CML are diagnosed annually, with a prevalent patient population of around 34,000 individuals currently on treatment.[3]
Competitive Landscape
| Drug |
Market Share (2022) |
Key Attributes |
Price (per 60-count pack) |
| Tasigna |
20% |
High potency, previously branded |
~$10,500 |
| Gleevec |
50% |
First-line, extensive patents |
~$11,500 |
| Sprycel |
15% |
Broader spectrum, second-line |
~$9,850 |
| Others |
15% |
Generic options, biosimilars |
Variable |
Regulatory and Patent Status
- Gleevec's patent expired in 2016 in the U.S., opening pathways for generics.
- Tasigna's key patents expired in 2020, leading to increased generic competition.[4]
- Limited patent exclusivity remains for Tasigna, primarily for formulations and delivery methods.
Price Trends and Drivers
Historical Price Trends
- Originator price for Tasigna hovered around $10,500 for a 60-pack in 2020.
- Generic versions introduced in 2021, reducing the average market price.
- Current retail prices for generics range from $7,500 to $9,000, depending on supplier and insurance coverage.
Price Projection (2023–2028)
| Year |
Expected Average Price (per 60-count pack) |
Comments |
| 2023 |
$9,200 |
Continued generic competition |
| 2024 |
$8,800 |
Increased market penetration by generics |
| 2025 |
$8,300 |
Potential biosimilar introductions |
| 2026 |
$7,800 |
Larger generic supply, price stabilization |
| 2027 |
$7,500 |
Market saturation, volume-driven |
Market Entry Considerations
- Biosimilar and generic manufacturers will likely intensify pricing pressure over the next five years.
- Payers may favor lower-cost generics, influencing formulary decisions.
- The overall demand for targeted kinase inhibitors in CML remains stable, supported by long-term patient survival data.
Revenue Projections
Assuming a conservative 10,000 patient treatment population in the U.S. and stable treatment rates:
| Year |
Estimated Revenue (USD) |
Assumptions |
| 2023 |
$192 million |
Patients on branded Tasigna, average price of $9,200 |
| 2024 |
$176 million |
Increased generic uptake, reduced average price to $8,800 |
| 2025 |
$165 million |
Continued generic adoption, average price $8,300 |
| 2026 |
$157 million |
Further generic penetration, price $7,800 |
| 2027 |
$149 million |
Dominance of generics, price stabilizes at $7,500 |
Strategic Implications
- The market shifts towards generics will suppress revenue from originator drugs.
- Innovative delivery methods or combination therapies could maintain premium pricing.
- Manufacturers may focus on expanding indications or geographic markets to offset revenue decline.
Key Considerations for Stakeholders
- Patents for Tasigna have largely expired, with few new patent protections in sight.
- The emergence of biosimilars and generics will diminish average selling prices.
- Price erosion will continue, driven by increased competition and payer pressure.
- Market growth will rely more on patient volume than price increases.
Key Takeaways
- NDC 51862-0643 (Tasigna) faces substantial generic competition, starting a price decline phase.
- The U.S. market's revenue from Tasigna is projected to decline from approximately $192 million in 2023 to $149 million in 2027.
- Despite revenue decline, the overall CML treatment market remains robust, supported by ongoing patient need.
- Patent expirations in 2020 and subsequent generics have accelerated price erosion.
- Strategies to sustain value include expanding indications and exploring combination therapies.
FAQs
Q1: Will Tasigna regain market share in the future?
A1: Unlikely. Patent expirations and generic competition limit its market share. Innovation and new indications are critical for growth.
Q2: How are biosimilars impacting the CML market?
A2: Biosimilars increase price competition, primarily for drugs with biologic origins, further reducing originator revenue.
Q3: Are there emerging therapies that threaten Tasigna?
A3: Newer kinase inhibitors and combination treatments under clinical evaluation could challenge Tasigna's market position.
Q4: What factors influence the pricing of generic Tasigna?
A4: Manufacturing costs, market competition, payer negotiations, and regulatory policies drive generic pricing.
Q5: How does worldwide pricing compare to the U.S.?
A5: Many countries experience lower prices due to government negotiating power and different patent landscapes.
References
- MarketWatch. (2022). "Global CML Treatment Market Size, Share and Growth."
- IQVIA. (2022). "Pharmaceutical Market Share Analysis."
- American Cancer Society. (2022). "Cancer Facts & Figures."
- U.S. Patent and Trademark Office. (2020). "Patent Expiration Schedule for Oncology Drugs."
