Last updated: February 13, 2026
Overview
NDC 16714-0200 refers to a branded pharmaceutical product marketed by Exelixis, Inc. It is identified as Cabozantinib, approved for indications including medullary thyroid carcinoma, hepatocellular carcinoma, and renal cell carcinoma.
Market Size and Sales Performance
The global market for cabozantinib-based therapies grew significantly following approval. In 2022, U.S. sales reached approximately $600 million, driven by indications such as renal cell carcinoma and hepatocellular carcinoma. Key factors include:
- Guideline Adoption: Inclusion in NCCN guidelines supports sustained demand.
- Market Penetration: Approximately 60% of eligible patients in the U.S. receive cabozantinib.
- Competition: Other tyrosine kinase inhibitors (TKIs) like sunitinib and pazopanib occupy market space but have different approval scopes.
Market Drivers
- Unmet Medical Need: Limited options for specific cancers.
- Regulatory Approvals: Expansion into new indications boosts sales prospects.
- Pricing Policies: US list prices for cabozantinib approximate $11,000 per month, with actual payer discounts ranging from 20-40%.
Pricing Dynamics and Regulatory Factors
- List Price: $11,000/month (as of 2023)
- Average Net Price: Estimated at $7,000-$8,800/month, considering rebates and discounts.
- Reimbursement: Mostly via Medicare, commercial insurance; formulary positioning is critical.
Market Outlook and Price Projections
- Expansion in Indications: Approval for additional cancers (e.g., prostate cancer) could grow sales by 15-25% over 3-5 years.
- Patent and Exclusivity Timeline: Patent protection until 2030, with potential for market exclusivity extensions.
- Generic Entry Risk: No generic version available until mid-2030s, preserving premium pricing.
Price Trajectory Scenarios
| Scenario |
Year |
Monthly Price per Unit |
Comments |
| Conservative |
2023-2024 |
$11,000 |
Current list price, no major changes |
| Moderate Increase |
2025-2027 |
$11,500 - $12,000 |
Slight price inflation, demand remains steady |
| Optimistic |
2028+ |
$13,000 - $14,000 |
Increased indication approvals, rapid adoption |
| Post-Generic Entry |
2030+ |
<$5,000 |
Price likely to drop significantly if generics enter |
Competitor Pricing
- Sunitinib (Nexavar): List price ~$10,000/month
- Lenvatinib (Lenvima): List price ~$10,175/month
- Pazopanib (Votrient): List price ~$9,000/month
These comparables suggest cabozantinib's pricing remains at the higher end of the TKI class spectrum, aided by broader indications and patent protection.
Regulatory and Policy Impact
Changes in healthcare policy, such as value-based pricing and increased biosimilar competition, could pressure prices downward post-2030. Current trends favor maintaining premium prices until generic equivalents are approved.
Risks and Opportunities
- Risks: Patent litigation, competitive therapies, regulatory delays.
- Opportunities: Combination therapies, new indication approvals, label expansion.
Summary
Cabozantinib under NDC 16714-0200 has a robust market with high current pricing supported by exclusive rights and multiple indications. Price projections suggest stable to slight increases until mid-decade, after which generics could significantly reduce prices.
Key Takeaways
- The current annual U.S. market for cabozantinib eclipses $600 million.
- List prices hover around $11,000/month, with net prices lower due to discounts.
- Patent expiry around 2030 indicates potential price erosion in the late 2020s.
- Expansion of indications can sustain revenue growth through 2027.
- Competition from other TKIs keeps prices competitive but keeps cabozantinib at the premium end.
FAQs
1. When will generic versions of cabozantinib enter the market?
Generic entry is expected after patent expiration around 2030, subject to potential patent extensions or litigation delays.
2. How do current prices compare with other TKIs?
Cabozantinib’s list price is similar or slightly higher than drugs like sunitinib and lenvatinib, reflecting its broader indications.
3. What factors could impact future pricing?
Regulatory changes, patent challenges, biosimilar developments, and shifts in reimbursement policies.
4. What new indications could influence the market?
Potential approvals for prostate cancer or other solid tumors could expand sales.
5. How might healthcare policy influence pricing trends?
Policy shifts toward value-based pricing and increased biosimilar adoption could reduce premiums over time.
Sources
[1] IQVIA, 2023. US Sales Data.
[2] Medicare and Commercial Payer Formularies.
[3] Exelixis, Inc. Regulatory Filings and Press Releases.
[4] FDA, 2023. Approved Indications for Cabozantinib.
[5] Industry Reports, 2023. Tyrosine Kinase Inhibitors Market Analysis.
