Last updated: February 23, 2026
What is NDC 31722-0678?
NDC 31722-0678 identifies Pemigatinib, marketed under the brand name Pemazyre. Developed by Incyte Corp., it is an oral kinase inhibitor approved by the FDA for the treatment of cholangiocarcinoma associated with fibroblast growth factor receptor (FGFR)2 gene fusions or rearrangements.
Current Market Landscape
Approved Indications & Usage
Pemazyre’s primary indication covers:
- Adults with previously treated, unresectable or metastatic cholangiocarcinoma with FGFR2 fusion or rearrangement.
Approved Indication Date
- FDA approval granted on April 17, 2020 (FDA, 2020).
Competitive Environment
The drug enters a niche market with limited direct competition. Key competitors include other FGFR inhibitors:
| Drug Name |
Manufacturer |
Approval Year |
Indications |
Price (Approximate) |
| Erdafitinib (Balversa) |
Janssen |
2019 |
Urothelial carcinoma |
$18,000/month |
| Infigratinib (Truseltiq) |
QED Therapeutics |
2021 |
Cholangiocarcinoma (off-label/clinical trials) |
Not FDA-approved locally |
| Pemigatinib (Pemazyre) |
Incyte |
2020 |
Cholangiocarcinoma with FGFR2 fusions |
$11,500/month |
Market Size & Penetration
- Estimated annual incident cases of cholangiocarcinoma: 8,000–10,000 globally; 2,500–3,000 in the U.S.
- FDA-approved targeted therapy adoption rate: Historically, initial uptake is 10-20% of eligible patients in the first two years, increasing as comprehensive genomic testing expands.
- Current prescription volume: Projected at ~1,200–1,500 annual prescriptions in the U.S. (based on historical niche oncology drug sales).
Price Projections
Factors Influencing Price
- Patent status and exclusivity agreements.
- Market penetration rates.
- Competitive landscape and off-label use.
- Pricing policies by health authorities and payers.
Short-term Price Outlook (Next 2 Years)
- Stable list price at approximately $11,500 per month.
- Price erosion expected if biosimilar or generic FGFR inhibitors gain regulatory approval or if biosimilar pathways emerge.
- Payer negotiations and value-based agreements could reduce net prices by 10–15%.
Long-term Price Trends (3–5 Years)
- Potential price reduction of 15–25% driven by increased competition and price pressures.
- Expansion into additional indications could sustain higher prices temporarily, but eventual price adjustments are likely.
- Biosimilar or more affordable oral kinase inhibitors could enter the market after patent expiry, likely reducing prices by 30–50%.
Revenue Estimates (2023–2025)
| Year |
Prescriptions (Estimated) |
Average Price |
Gross Revenue |
| 2023 |
1,200 |
$11,500/month |
~$16.5 million annually |
| 2024 |
1,500 |
$11,500/month |
~$20.6 million annually |
| 2025 |
2,000 |
$10,500/month (adjusted) |
~$25.2 million annually |
Regulatory and Policy Impact
- The potential for label expansion to other FGFR-altered cancers could expand market size.
- Reimbursement policies and coverage decisions critically influence realized prices.
- Patent protections expected until approximately 2027–2028, after which biosimilars may enter.
Summary of Key Data Points
- FDA approval date: April 17, 2020.
- Current list price: ~$11,500/month.
- Estimated annual prescriptions (US): 1,200–1,500.
- Market size: 2,500–3,000 patients in the US.
- Competitive landscape: Limited; ERdafitinib (Janssen), pipeline agents (Infigratinib).
- Patent expiration: Anticipated around 2027–2028.
Key Takeaways
- Pemazyre has a niche but growing market among cholangiocarcinoma patients with FGFR2 alterations.
- List prices remain stable with slight erosion expected as competition and biosimilar options develop.
- Market penetration hinges on genomic testing adoption and regulatory guidance.
- Revenue growth is constrained by the small patient population, but expansion into other indications could improve prospects.
- Price erosion will accelerate after patent protection lapses, likely lowering prices by approximately 30–50%.
FAQs
1. What is the primary driver for Pemazyre’s current market value?
The drug’s targeted mechanism and FDA approval for specific genetic alterations in cholangiocarcinoma determine its limited but high-value niche.
2. How does Pemazyre’s pricing compare internationally?
International prices vary, often lower due to pricing negotiations; in some countries, it costs roughly 50-70% of the US list price.
3. When is patent expiration expected for Pemazyre?
Patent protections are targeted to expire around 2027–2028, opening pathways for biosimilars and generics.
4. What factors could significantly alter the price trajectory?
Entry of biosimilars, new indications, changes in payer policies, or regulatory shifts towards pricing controls.
5. Can off-label use impact market size?
Yes, if off-label prescribing increases in related cancers with FGFR alterations, it could enlarge the market and support higher prices temporarily.
References
- FDA. (2020). FDA approves Pemazyre for cholangiocarcinoma. Food and Drug Administration.
- Incyte. (2022). Pemazyre (pemigatinib) prescribing information.
- IQVIA. (2022). Global Oncology Market Reports.
- QED Therapeutics. (2022). Infigratinib clinical pipeline data.
- Janssen. (2021). Balversa (erdafitinib) prescribing details.
