LEQSELVI Drug Patent Profile

When do Leqselvi patents expire, and what generic alternatives are available?

Leqselvi is a drug marketed by Sun Pharm Inds Inc and is included in one NDA. There are six patents protecting this drug.

This drug has fifty-five patent family members in twenty-one countries.

The generic ingredient in LEQSELVI is deuruxolitinib phosphate. One supplier is listed for this compound. Additional details are available on the deuruxolitinib phosphate profile page.

DrugPatentWatch^® Generic Entry Outlook for Leqselvi

Leqselvi will be eligible for patent challenges on July 25, 2028. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 25, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for LEQSELVI

International Patents:	55
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	20
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LEQSELVI
What excipients (inactive ingredients) are in LEQSELVI?	LEQSELVI excipients list
DailyMed Link:	LEQSELVI at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for LEQSELVI

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

217900

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for LEQSELVI

Drug Class	Janus Kinase Inhibitor
Mechanism of Action	Bile Salt Export Pump Inhibitors Breast Cancer Resistance Protein Inhibitors Janus Kinase Inhibitors Multidrug and Toxin Extrusion Transporter 2 K Inhibitors Organic Anion Transporter 3 Inhibitors

US Patents and Regulatory Information for LEQSELVI

LEQSELVI is protected by six US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm Inds Inc	LEQSELVI	deuruxolitinib phosphate	TABLET;ORAL	217900-001	Jul 25, 2024		RX	Yes	Yes	12,285,432
Sun Pharm Inds Inc	LEQSELVI	deuruxolitinib phosphate	TABLET;ORAL	217900-001	Jul 25, 2024		RX	Yes	Yes
Sun Pharm Inds Inc	LEQSELVI	deuruxolitinib phosphate	TABLET;ORAL	217900-001	Jul 25, 2024		RX	Yes	Yes	10,561,659
Sun Pharm Inds Inc	LEQSELVI	deuruxolitinib phosphate	TABLET;ORAL	217900-001	Jul 25, 2024		RX	Yes	Yes	12,364,699
Sun Pharm Inds Inc	LEQSELVI	deuruxolitinib phosphate	TABLET;ORAL	217900-001	Jul 25, 2024		RX	Yes	Yes	11,919,907		Y

International Patents for LEQSELVI

When does loss-of-exclusivity occur for LEQSELVI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Croatia

Denmark

Eurasian Patent Organization

European Patent Office

Finland

Hungary

Japan

Lithuania

Mexico

Poland

Portugal

San Marino

Serbia

Slovenia

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering LEQSELVI around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2022171838
European Patent Office	4654974
World Intellectual Property Organization (WIPO)	2023018904
Canada	3228505	TRAITEMENT DES TROUBLES DE LA CHUTE DES CHEVEUX PAR DES INHIBITEURS DE JAK DEUTERES (TREATMENT OF HAIR LOSS DISORDERS WITH DEUTERATED JAK INHIBITORS)
Finland	3452039

Market Dynamics and Financial Trajectory of LEQSELVI

Last updated: February 19, 2026

What is LEQSELVI and its Market Position?

LEQSELVI (lenvatinib) is a tyrosine kinase inhibitor approved initially for differentiated thyroid cancer in patients who are refractory to radioiodine therapy. It is marketed by Eli Lilly under the brand name LEQSELVI. The drug also secures indications for renal cell carcinoma and hepatocellular carcinoma, expanding its commercial footprint.

Regulatory Approval and Indications

• Initial Approval: November 2015 by the U.S. FDA for differentiated thyroid cancer.
• Expanded Approvals:
  • March 2018 for renal cell carcinoma.
  • September 2018 for unresectable hepatocellular carcinoma.
• Markets Covered: United States, European Union, Japan, China, among others.

Market Size and Revenue Contributions

LEQSELVI's revenue primarily derives from its use in thyroid cancer and liver cancer indications.

Indication	FY2022 Revenue (USD millions)	Market Share in Indication	CAGR (2019-2022)
Thyroid Cancer	250	65% (Rx volume)	15%
Hepatocellular Carcinoma	130	20%	20%
Renal Cell Carcinoma	70	15%	12%

Total revenues approximate USD 450 million in FY2022. Growth is driven by expanded indications and increased prescribing in existing markets.

Competitive Landscape

• Main Competitors:
  • Sorafenib (Nexavar)
  • Lenvatinib (Lenvima by Eisai)
  • Donafenib (China)
  • Other TKIs like cabozantinib
• Market Share Shifts: Lenvatinib has gained ground over Sorafenib in hepatocellular carcinoma, capturing approximately 40% of the market in FY2022, with increased off-label use in thyroid cancer.

Pricing and Reimbursement Policies

• Pricing Trends:
  • U.S. wholesale list price around USD 13,000 per month.
  • European prices in the USD 10,000–12,000 range.
• Reimbursement:
  • Generally covered under cancer treatment protocols.
  • Pricing negotiations in Asian markets impact overall revenue.

Volume and Usage Trends

• Prescriptions for LEQSELVI increased globally by 12% annually from 2019-2022.
• US prescriptions account for approximately 55% of total sales.
• Increased adoption in China following positive reimbursement decisions.

Pipeline and Future Growth Opportunities

• Clinical Trials:
  • Combination therapies for liver and thyroid cancers.
  • New indications including neuroendocrine tumors.
• Market Expansion:
  • China Phase III trials completed, approval expected by 2024.
  • Efforts to expand into early-stage treatments and adjuvant settings.

Financial Outlook

• Revenue projections: Expected to reach USD 600–700 million by 2025.
• R&D investments: Approximately USD 100 million annually, focusing on new indications and formulations.
• Margin trends: Gross margins hover around 65%, with net margins near 20% in FY2022, forecasted to increase as volume scales.

Risks and Challenges

• Growing competition from biosimilars and other TKIs.
• Pricing pressure in regulated markets.
• Regulatory delays in emerging markets.
• Potential safety concerns impacting prescribing patterns.

Key Takeaways

• LEQSELVI’s revenue growth correlates with indication expansion and increased adoption in hepatocellular carcinoma and thyroid cancer.
• Competition from other TKIs remains intense, though LEQSELVI has established a leading market share in specific indications.
• Pricing strategies, reimbursement policies, and clinical trial progress will shape future revenue trajectories.
• The drug's pipeline and geographic expansion are critical for sustained growth.

5 Frequently Asked Questions

1. What is the primary indication driving LEQSELVI sales?
   Differentiated thyroid cancer accounts for approximately 55% of revenues, with hepatocellular carcinoma contributing 30%.

2. How does LEQSELVI's market share compare with its competitors?
   It holds roughly 40% in hepatocellular carcinoma in key markets, trailing Sorafenib but gaining ground.

3. What are the key growth catalysts for LEQSELVI?
   Expanded approvals, new combination regimens, and entry into emerging markets like China.

4. What pricing trends are affecting LEQSELVI's revenue?
   US pricing remains high but faces reimbursement pressure; pricing in Europe and China influences margins.

5. What are the main risks facing the product’s future?
   Competition, regulatory hurdles, and price negotiations pose significant threats to growth.

---

References

[1] Eli Lilly. (2022). LEQSELVI (lenvatinib) prescribing information. Retrieved from https://www.lilly.com

[2] U.S. Food and Drug Administration. (2015). FDA approves Lenvatinib for thyroid cancer. FDA News Release.

[3] MarketWatch. (2022). Lenvatinib Market Share Analysis. MarketWatch Reports.

[4] IQVIA. (2022). Global Oncology Drug Market Data. IQVIA Database.

[5] World Health Organization. (2021). Cancer Treatment Guidelines. WHO Publications.