Last updated: February 24, 2026
What is NDC 16729-0171?
NDC 16729-0171 refers to Sorafenib Tosylate (brand name: Nexavar). It is an oral multikinase inhibitor approved by the FDA in 2005 for treatment of hepatocellular carcinoma, renal cell carcinoma, and thyroid carcinoma. The drug is marketed by Bayer and has a patent set to expire in 2023.
Market Size and Current Sales (2022-2023)
| Metric |
Data |
| Global market size (2022) |
Approx. $1.2 billion (estimated) [1] |
| U.S. market share (2022) |
60% of global sales [2] |
| Revenue (2022) |
~$720 million in U.S. |
| Sales growth (2020-2022) |
Compound annual growth rate (CAGR): 3.5% [3] |
Competitive Landscape
Major Competitors
- Lenvatinib (Lenvima)
- Regorafenib (Stivarga)
- Cabozantinib (Cabometyx)
- Sorafenib faces competition mainly in hepatocellular carcinoma (HCC) and renal cell carcinoma (RCC) markets.
Patent and Exclusivity Timeline
- Original patent expired in 2023.
- Similar formulations now primarily off-patent.
- Patent litigation and data exclusivity for biosimilars may influence generic entry timelines.
Pricing Dynamics
Current Pricing (U.S.)
- Average retail price per 200 mg tablet: $60 - $80.
- Monthly treatment cost (standard dosing): approximately $4,200 - $5,600.
- Price varies based on discounts, insurance coverage, and pharmacy.
Reimbursement Landscape
- Reimbursed through Medicare/Medicaid.
- Coverage policies often favor negotiated prices with payers.
- High copayments may limit access for some patients.
Price Projection (Next 5 Years)
| Year |
Estimated Price Range per Unit |
Justification |
| 2023 |
$60 - $80 |
Post-patent expiration, initial generic entry begins. |
| 2024 |
$50 - $70 |
Increased generic competition, price erosion begins. |
| 2025 |
$40 - $60 |
Market stabilization with multiple generics available. |
| 2026 |
$35 - $50 |
Continued competition, potential biosimilar entry. |
| 2027 |
$30 - $45 |
Mature generic market, lowest prices achieved. |
Factors Influencing Prices
- Number of generics entering the market.
- Regulatory approval of biosimilars.
- Payer negotiation leverage.
- Manufacturing costs.
- Global market influence, particularly in Europe and Asia.
Market Entry Impact
The expiration of patents and exclusivities in 2023 likely will lead to significant price reductions and increased access. Product availability of biosimilars and generics can reduce prices by as much as 50-70%.
In jurisdictions with strong price regulation, such as the EU, prices may decrease more rapidly. Conversely, in markets with less price regulation or with supply constraints, prices might remain higher temporarily.
Strategic Considerations for Stakeholders
For Generic Manufacturers
- Rapid market entry post-2023 will be critical.
- Focus on regulatory filing for biosimilars.
- Leverage volume-based pricing to maximize market penetration.
For Payers and Healthcare Providers
- Prioritize negotiated discounts.
- Monitor biosimilar formulations for therapeutic equivalence.
- Consider cost-effectiveness models when prescribing.
For Bayer (Brand Owner)
- Possible strategies include patent defense via litigation.
- Investing in new formulations or combination therapies to extend lifecycle.
- Market focus may shift toward biosimilars and generics.
Key Takeaways
- NDC 16729-0171 (Sorafenib) is nearing patent expiration, opening market to generics.
- U.S. prices are approximately $60-$80 per 200 mg tablet, with steep declines expected over the next three years.
- Market growth remains modest due to saturation and competition, but volume increases with lower prices.
- Competitive entry influenced by regulatory approvals and patent litigation will shape future pricing.
- Global pricing dynamics will vary, with high-income markets experiencing quicker price declines than emerging markets.
FAQs
1. When will generic versions of NDC 16729-0171 become available?
Generic versions are expected to enter the U.S. market in 2023 following patent expiration, with biosimilar products potentially available by 2024.
2. How much could prices decline post-patent expiry?
Prices could fall by 50-70%, reducing the retail cost per tablet to roughly $30-$45.
3. What factors could delay generic market penetration?
Regulatory hurdles, patent litigation, manufacturing delays, or market reluctance can slow generic entry.
4. Are biosimilars available for Sorafenib?
As of 2023, no biosimilars have received FDA approval; most competition will come from small-molecule generics.
5. How will market access change globally?
Prices in high-income countries are likely to decrease faster, while emerging markets may see slower declines due to import restrictions and price controls.
References
[1] IQVIA. (2022). Pharmaceutical Market Reports.
[2] EvaluatePharma. (2022). World Preview 2023, Outlook to 2028.
[3] Bloomberg Intelligence. (2022). Cancer Therapies Market Analysis.
