Last updated: February 17, 2026
What is the current market status for NDC 00527-0791?
NDC 00527-0791 corresponds to Bristol-Myers Squibb’s drug Sprycel (dasatinib), indicated primarily for the treatment of chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). As of the latest data (2023), it maintains a significant share within the kinase inhibitor segment for cancer therapies.
The global CML market was valued at approximately USD 2.7 billion in 2022, with Sprycel accounting for a notable portion. The drug’s position derives from its efficacy in patients resistant or intolerant to prior therapies such as imatinib.
What are the key factors impacting the market?
- Patent status: Sprycel’s primary patents expired in 2022-2023 in the U.S. and Europe, leading to patent challenges and the entry of biosimilars or generics.
- Competitive landscape: First-generation TKI imatinib (Gleevec) dominates initial treatment, while second-generation TKIs like dasatinib face increasing competition from newer agents such as bosutinib, ponatinib, and emerging therapies.
- Regulatory developments: Accelerated approvals or additional indications can influence sales. No recent major label extensions have been granted.
What is the current price landscape?
Branded Sprycel
- In the U.S., the average wholesale price (AWP) for monthly treatment (100 mg daily) approximates USD 15,000–USD 17,000.
- Per unit (100 mg tablet), prices range from USD 400–USD 450.
Biosimilar and generic options
- As patents expired, several generics entered the market in 2023, with prices dropping by approximately 50% or more.
- The initial generic versions are priced between USD 6,000–USD 8,000 per month, representing significant cost reductions.
Price comparison (2023 estimates)
| Product Type |
Monthly Price (USD) |
Patent Status |
Market Penetration |
| Branded Sprycel |
15,000–17,000 |
Patented until 2023 |
Leading therapy in resistant cases |
| Generics/Biosimilars |
6,000–8,000 |
Patented from 2023 |
Increasing use in first- and second-line |
What are the price projections moving forward?
- Short-term (1–2 years): Prices of branded Sprycel are expected to decline further as biosimilar market penetration deepens. By 2025, branded prices might decrease by an additional 10–20%. Average prices for generics could stabilize around USD 4,000–USD 6,000.
- Medium-term (3–5 years): Competition from newer TKIs and potential emergence of combination therapies can impact market share. Biosimilar prices may trend downward if multiple entrants increase competition, possibly reaching USD 3,000–USD 4,000 per month.
- Long-term (5+ years): Patent exclusivity losses grant broader generic access, stabilizing prices. Pricing may reflect standard oncology biosimilar reductions, around USD 2,000–USD 4,000 per month, depending on reimbursement and healthcare system dynamics.
What are the market risks and growth opportunities?
Risks
- Patent overturns and legal challenges.
- Development of novel targeted therapies with superior efficacy or safety profiles.
- Shifts in healthcare policy affecting drug reimbursement.
Opportunities
- Expansion into additional indications, such as other leukemias or solid tumors.
- Growth in emerging markets expanding access.
- Development of combination regimens that incorporate dasatinib.
Summary Table: Price Evolution Overview (USD)
| Year |
Branded Price |
Generic Price Range |
Notes |
| 2023 |
15,000–17,000 |
6,000–8,000 |
Post-patent expiry, initial generic entry |
| 2024 |
13,500–15,300 |
5,400–7,200 |
Continued biosimilar uptake |
| 2025 |
12,000–14,000 |
4,800–6,400 |
Market stabilization, increased competition |
Key Takeaways
- Market: Sprycel remains a key therapy but faces patent expirations heightening competition.
- Pricing: Branded prices have decreased since patent expiry; generics have halved pricing.
- Projections: Prices are expected to decline further over the next 2–5 years, stabilizing as multiple generics penetrate the market.
- Opportunities: Expansion into new indications and emerging markets offers potential growth.
FAQs
Q1: How does patent expiration affect drug pricing?
Patent expiration allows generic manufacturers to enter the market, usually leading to significant price reductions, as seen with dasatinib dropping from USD 15,000–USD 17,000 to approximately USD 6,000–USD 8,000 monthly.
Q2: What is the current competitive landscape for dasatinib?
The market includes biosimilar and generic versions, with newer TKIs and combination therapies emerging. Biosimilars are gaining market share, especially outside the U.S.
Q3: Will prices stabilize or continue to decline?
Prices are projected to decline over the next 2–5 years but may stabilize as competition matures and market share consolidates.
Q4: Are there regulatory factors influencing future prices?
Yes. Regulatory policies on biosimilars, reimbursement frameworks, and potential new indications can influence pricing dynamics.
Q5: How do biosimilars impact the long-term profitability of dasatinib?
Biosimilar entry typically reduces profit margins for original branded products but can expand overall market volume, potentially offsetting revenue declines for the originator.
Sources:
- [1] EvaluatePharma. "Cancer Therapies Market Outlook 2023."
- [2] IQVIA. "Global Oncology Drug Market Data 2022."
- [3] U.S. FDA. "Biosimilar Product Information," 2023.
- [4] MarketWatch. "Cancer drug price trends post-patent expiry," 2023.
- [5] Pharma Intelligence. "TKI Market Dynamics," 2023.
