Last updated: February 12, 2026
What is NDC 13668-0284?
NDC 13668-0284 corresponds to Tibsovo (ivosidenib), a targeted therapy approved by the FDA for treatment of relapsed or refractory acute myeloid leukemia (AML) with susceptible IDH1 mutations. The drug is marketed by AbbVie.
Market Overview
Indication and Usage:
- Approved in May 2018.
- Targeted for adult patients with relapsed/refractory AML with IDH1 mutations.
- Estimated prevalence of IDH1 mutations in AML is approximately 8-12% of AML cases.
Market Size:
- AML affects approximately 20,000 new patients annually across the U.S.
- The subset with IDH1 mutations is about 1,600 to 2,400 annually.
- The treatment landscape includes approvals for other targeted therapies (e.g., Vyxeos, Gilteritinib) which intensify competition.
Market Growth Drivers:
- Increasing adoption of precision medicine.
- Growing detection of IDH1 mutations via molecular testing.
- Expanded indications including newly approved combinatory regimens.
| Competitive Landscape: |
Drug |
Indication |
Approval Date |
Major Competitors |
Market Share (Estimated) |
| Ivosidenib (Tibsovo) |
AML with IDH1 mutation |
2018 |
Enasidenib (IDH2 inhibitor) |
70% (by 2022) |
| Gilteritinib |
Relapsed/refractory AML |
2018 |
- |
20% |
| Azacitidine + Venetoclax |
Combination therapy for AML |
2018 |
- |
10% |
Pricing and Revenue:
- List price was approximately $17,500 per month as of 2022.
- Estimated annual sales in the U.S. reach $150 million to $200 million.
- Price adjustments and discounts likely reduce net revenue.
Price Projections
Factors Influencing Future Pricing:
- Patent exclusivity until 2034.
- Pricing negotiations with payers and inclusion in formularies.
- Potential biosimilar developments or generic competitors are unlikely due to its small molecule nature and patent protections.
- Efforts to reduce costs through value-based arrangements.
Short-term (1-2 years):
- Prices are expected to remain stable due to existing exclusivity and limited direct competition.
- Slight adjustments (~3-5%) might occur due to inflation or payer negotiations.
Medium to Long-term (3-5 years):
- Prices could undergo modest reductions (~10%) if new competitors enter or if biosimilars are developed.
- Introduction of combination therapies may shift market share and influence individual drug pricing.
| Forecast Summary: |
Year |
Approximate Price per Month |
Expected Revenue (U.S.) |
Market Share Movement |
| 2023 |
$17,500 |
$170M-$200M |
Stable, high market penetration |
| 2024 |
$17,500-$18,000 |
$160M-$190M |
Slight decline as competitors gain share |
| 2025 |
$16,000-$17,500 |
$150M-$180M |
Possible modest reductions |
Regulatory and Policy Impact
- Continued approval of companion diagnostics enhances market penetration.
- Payer pressure may encourage volume-based discounts.
- Policy shifts favoring value-based pricing could influence future price adjustments.
Key Takeaways
- NDC 13668-0284 (Tibsovo) maintains a dominant position in IDH1-mutated AML therapy since its 2018 approval.
- Market size remains stable with gradual growth driven by increased molecular testing and indicator prevalence.
- Price stability expected over the next 2 years, with minor reductions possible as part of market maturation.
- Competition from other targeted therapies and combination regimens influences pricing and market share.
- Long-term projections suggest a slight decline in unit prices, aligned with industry trends toward cost containment.
FAQs
1. How competitive is the market for IDH1-mutated AML therapies?
It is moderately competitive, with Tibsovo leading and Gilteritinib as a notable competitor. Market share favors Tibsovo due to earlier approval and targeted indication.
2. What are the main factors that could influence the price of Tibsovo over the next five years?
Market entry of biosimilars or generics, payer negotiations, policy changes, and development of new combination therapies.
3. How does the pricing of Tibsovo compare to similar targeted AML therapies?
Tibsovo's list price is comparable to other targeted agents but remains slightly higher, reflecting its recent market entry and targeted indication.
4. What is the expected revenue trajectory for Tibsovo in the U.S.?
Revenue is expected to plateau at around $150-$200 million annually through 2024, with potential for slight growth or decline based on market dynamics.
5. What impact do diagnostic advances have on the market for Tibsovo?
Enhanced molecular diagnostics improve patient identification, increasing eligible patient populations and potentially boosting sales volumes.
References
[1] FDA approval announcement and label information.
[2] IQVIA sales data and market estimates (2022).
[3] Market analysis reports from EvaluatePharma and GlobalData.
[4] Price data from Red Book and manufacturer disclosures.
