Last updated: February 14, 2026
Overview
NDC 80610-0130 corresponds to the drug Tasigna (nilotinib), a tyrosine kinase inhibitor primarily used for treating chronic-phase and accelerated-phase Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in adult patients. Approved by the FDA in 2007, Tasigna faces competition from other TKIs, notably Gleevec (imatinib), Sprycel (dasatinib), and others. Market dynamics are shaped by patent status, emerging biosimilars, manufacturing costs, and evolving treatment guidelines.
Market Landscape
1. Indications & Patient Population
- Primary indication: CML (chronic and accelerated phases).
- Estimated U.S. patient base: 6,000–8,000 new cases annually, with a steadily aging population.
- Market growth factors: Advances in diagnostic accuracy and treatment adherence, along with expanded indications in resistant or intolerant patients.
2. Competitive Environment
| Drug |
Approval Date |
Patent Status |
Market Share (2022) |
Pricing Status |
| Tasigna (nilotinib) |
2007 |
Patent expired in 2022 (U.S.) for primary patents |
Approx. 25% |
Originally priced high; facing biosimilar entry |
| Gleevec (imatinib) |
2001 |
Patent expired in 2016 |
Approx. 50% |
High initial price; discounting trends observed |
| Sprycel (dasatinib) |
2006 |
Patent active until ~2027 |
Approx. 20% |
High price, under insurance negotiation |
Patent expiration influences price competition, especially for drugs like Tasigna. However, patent litigation, exclusivity periods, and regulatory data exclusivity continue to impact pricing.
3. Pricing & Cost Analysis
Historical Pricing:
- Original wholesale acquisition cost (WAC): ~$8,000 - $10,000 per month (~$96,000 - $120,000 annually).
- Post-patent expiration, prices for branded products often decline 10-30% in initial phase due to generic or biosimilar entry, although Tasigna remains branded with no generic versions as of 2023.
Current Pricing (2023):
| Parameter |
Approximate Value |
| Monthly WAC |
~$7,200 |
| Annual WAC |
~$86,400 |
| Discounted cash price (insurers, hospitals) |
$50,000 - $70,000 annually |
Market access and discounts vary depending on payor negotiations and patient assistance programs.
4. Revenue & Market Projections
- U.S. Market Revenue (2022): Estimated at $300–$400 million for Tasigna.
- Growth Drivers: Increased adoption in resistant or intolerant cases, potential new indications, and refining of treatment protocols.
- Decline Factors: Patent expiry, biosimilar competition, and biosimilar development pipeline.
5. Future Price Trends
| Year |
Expected Price Change |
Rationale |
| 2024 |
0-10% decrease |
Entry of biosimilars expected globally, though U.S. patent status limits immediate generic competition. |
| 2025–2027 |
10–20% decrease |
Patent exclusivity expiration for key formulations, increased biosimilar/similar competition. |
Long-term price erosion is likely as biosimilars enter the market and healthcare payers negotiate better discounts.
Key Market Challenges and Opportunities
- Patent expiration and biosimilar development threaten revenue stability.
- Increasingly personalized medicine approaches require real-world efficacy data.
- Rare patient populations may limit overall market size but can sustain premium pricing in niche segments.
Regulatory Outlook & Policy Impact
- Patent litigation and regulatory developments influence pricing timelines.
- Policies favoring biosimilar proliferation could accelerate price reductions.
- Incentives for biosimilar development and approval pathways shaping future competition.
Key Takeaways
- NDC 80610-0130 (Tasigna) commands high prices initially, but revenue is susceptible to patent expiry and biosimilar entry.
- Patient growth remains steady, but market saturation and competition suppress long-term pricing potential.
- Price projections suggest modest declines over the next 2-3 years, accelerated by biosimilar market entry and policy shifts.
- Revenue stability depends on ongoing indications, efficacy data, and negotiations with payers.
- Long-term market viability hinges on differentiation via new indications or combination therapies.
FAQs
1. What factors most influence Tasigna’s pricing?
Patent status, competition from biosimilars, treatment guidelines, and negotiations with insurers.
2. How does patent expiration affect the drug’s market?
Patent expiration typically leads to generic or biosimilar entry, reducing prices and market share for branded versions.
3. Are biosimilars available for Tasigna?
As of 2023, biosimilars are not yet approved for Tasigna in the U.S., but development is ongoing for similar TKIs.
4. What is the potential impact of regulatory changes?
Pricing could decline if policies promote biosimilar uptake or if patent litigations favor generic entry.
5. How does Tasigna compare to other TKIs in pricing and market share?
Tasigna’s initial price was comparable to Gleevec and Sprycel; however, market share shifts depend on efficacy, tolerability, and patent status.
Sources
[1] FDA Drug Database, 2022.
[2] IQVIA National Prescription Audit, 2022.
[3] Evaluate Pharma, 2022.
[4] PhRMA Annual Report, 2022.
