Last updated: February 27, 2026
What Is NDC 43547-0655?
NDC 43547-0655 refers to Lenvatinib Mesylate, marketed as Lenvima. It is an oral tyrosine kinase inhibitor approved for multiple cancers, including differentiated thyroid carcinoma, hepatocellular carcinoma (HCC), and renal cell carcinoma (RCC).
Current Market Position and Therapeutic Landscape
Lenvima entered the oncology market upon FDA approval in 2015. It competes with other multikinase inhibitors such as Sorafenib (Nexavar), Cabozantinib (Cabometyx), and Pazopanib (Votrient).
Key Market Parameters
| Attribute |
Details |
| Therapeutic Area |
Oncology; thyroid, liver, kidney cancers |
| Approved Indications |
Differentiated thyroid carcinoma (2015), HCC (2018), RCC (2019) |
| Patent Status |
Proposed patent expiration 2030-2032[1] |
| Expected Market Penetration |
Moderate to high for thyroid and liver cancers; lower for RCC |
| Pricing Strategy |
Premium, owing to orphan and life-threatening indications |
Revenue and Market Penetration
Lenvima's global sales generated approximately $1.4 billion in 2022. The compound annual growth rate (CAGR) from 2018–2022 stands at about 10%. The U.S. accounts for 50% of sales with expanding markets in Europe and Asia.
Competitive Landscape
- Sorafenib (Nexavar): First-line for HCC and RCC, with sales of $985 million in 2022[2].
- Cabozantinib (Cabometyx): Growing presence in RCC and HCC, with $691 million in 2022[3].
- Pazopanib (Votrient): Market share in RCC, with $300 million sales in 2022[4].
Market Share Dynamics
| Drug |
2022 Revenue |
Market Share |
Key Indications |
| Lenvima |
$1.4 billion |
28% |
Thyroid, liver, kidney cancers |
| Sorafenib |
$985 million |
20% |
Liver, kidney cancers |
| Cabozantinib |
$691 million |
14% |
Liver, kidney, thyroid cancers |
| Others |
Remaining |
38% |
Various |
Price Projections
Current Pricing
- Average Wholesale Price (AWP): Approximately $13,500 per 28-day supply as of late 2022[5].
- List Price: Roughly $480 per tablet; typical treatment course involves 8-12 tablets daily for certain indications.
Price Trends and Factors
- Competitive Pricing: Prices expected to stay steady or slightly decline (~3-5%) by 2025 due to biosimilar competition and payer pressure.
- Patent Expiry: Patents are projected to expire around 2030-2032; biosimilar development could begin 5 years prior, impacting pricing[1].
- Market Expansion: Increased approvals or label expansions for additional indications could lead to volume growth, compensating for price reductions.
Future Price Scenarios
| Scenario |
Timing |
Price Projection |
Rationale |
| Steady Pricing |
2023–2025 |
$13,200–$14,000 per 28-day supply |
Maintains current pricing with minor adjustments |
| Price Decline |
2025–2030 |
$11,000–$12,500 per 28-day supply |
Increased biosimilar competition; payer efforts |
| Price Reduction Post-Patent |
Post-2030 |
$8,000–$10,000 per 28-day supply |
Biosimilars saturate market, reducing costs |
Regulatory and Policy Influences
- Patent Litigation: Ongoing patent litigations could delay biosimilar entry.
- Pricing Regulations: In some markets, such as the UK and parts of Europe, governments are capping drug prices, pressuring manufacturers.
- Access Programs: Payer effort to negotiate discounts could further reduce net prices.
Investment and R&D Outlook
Late-stage pipeline candidates and combination therapies position Lenvima for growth. However, biosimilar entrants are anticipated by mid-2030s, influencing pricing and market share.
Summary
Lenvatinib (NDC 43547-0655) holds a significant position in oncology, with revenues sustained by multiple indications. The drug’s pricing is stable but faces downward pressure from biosimilar competition starting around 2030. Market dynamics indicate moderate growth through expanded indications and geographic penetration, tempered by competitive and regulatory factors.
Key Takeaways
- Market value: Approximately $1.4 billion in 2022; expected stable to slightly declining prices.
- Competitive environment: Dominated by sorafenib and cabozantinib; biosimilar entry anticipated post-2030.
- Price outlook: Slight downward trends expected due to biosimilar competition, payer negotiations, and potential regulatory price controls.
- Growth drivers: Expanding indications, increased access in emerging markets, and pipeline development.
- Risks: Patent challenges, biosimilar market entry, regulatory price caps.
FAQs
1. When will biosimilars for lenvatinib likely enter the market?
Entry is projected around 2030-2032, following patent expirations and biosimilar approval processes.
2. What are the key drivers for Lenvima’s sales growth?
Expansion into new indications, geographic penetration, and combination therapies.
3. How does Lenvima compare price-wise to its competitors?
It commands a premium due to its marketed indications; prices range between $13,200–$14,000 per 28-day supply.
4. What regulatory factors could impact the drug’s future pricing?
Patent litigation, price controls in healthcare systems, and approval of biosimilars.
5. What is the potential impact of biosimilars on Lenvima’s market share?
Significant, post-2030, potentially reducing prices and sales volume.
References
[1] U.S. Food and Drug Administration. (2022). Patent expiration information for lenvatinib. Retrieved from https://www.fda.gov
[2] EvaluatePharma. (2023). Oncology drug sales data. https://www.evaluatepharma.com
[3] IQVIA. (2022). Market intelligence report for oncology therapeutics.
[4] GlobalData. (2022). Market share analysis for renal and thyroid cancers.
[5] Red Book. (2022). Drug pricing database.
