TAVALISSE Drug Patent Profile

When do Tavalisse patents expire, and when can generic versions of Tavalisse launch?

Tavalisse is a drug marketed by Rigel Pharms and is included in one NDA. There are fourteen patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty patent family members in forty-six countries.

The generic ingredient in TAVALISSE is fostamatinib disodium. One supplier is listed for this compound. Additional details are available on the fostamatinib disodium profile page.

DrugPatentWatch^® Generic Entry Outlook for Tavalisse

Tavalisse was eligible for patent challenges on April 17, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 27, 2032. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for TAVALISSE

International Patents:	120
US Patents:	14
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TAVALISSE

Paragraph IV (Patent) Challenges for TAVALISSE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TAVALISSE	Tablets	fostamatinib disodium	100 mg and 150 mg	209299	1	2022-04-18

US Patents and Regulatory Information for TAVALISSE

TAVALISSE is protected by fourteen US patents.

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
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-002	Apr 17, 2018		RX	Yes	Yes			Y
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-001	Apr 17, 2018		RX	Yes	No
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-002	Apr 17, 2018		RX	Yes	Yes				Y
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-002	Apr 17, 2018		RX	Yes	Yes			Y
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-001	Apr 17, 2018		RX	Yes	No				Y
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-001	Apr 17, 2018		RX	Yes	No				Y

International Patents for TAVALISSE

When does loss-of-exclusivity occur for TAVALISSE?

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

Argentina

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Finland

Hong Kong

Hungary

Japan

Lithuania

Mexico

Poland

Portugal

San Marino

Serbia

Slovenia

South Korea

Spain

Taiwan

Turkey

Uruguay

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 TAVALISSE around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	E451381
Australia	2006206458	Prodrugs of 2,4-pyrimidinediamine compounds and their uses
Brazil	PI0606318	composto, composição, e, uso de um composto
Canada	2591948	PROMEDICAMENTS DE COMPOSES DE 2,4-PYRIMIDINEDIAMINE ET LEURSUTILISATIONS (PRODRUGS OF 2,4-PYRIMIDINEDIAMINE COMPOUNDS AND THEIR USES)
China	101115761	Prodrugs of 2,4-pyrimidinediamine compounds and their uses
Cyprus	1109888

Supplementary Protection Certificates for TAVALISSE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1856135	SPC/GB20/016	United Kingdom		PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE, SOLVATE OR N-OXIDE OF FOSTAMATINIB OR THE PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REGISTERED: UK EU/1/19/1405 (NI) 20200113; UK PLGB 12930/0022 20200113; UK PLGB 12930/0023 20200113
1856135	C20200009 00319	Estonia		PRODUCT NAME: FOSTAMATINIIB;REG NO/DATE: EU/1/19/1405 13.01.2020
1856135	122020000021	Germany		PRODUCT NAME: FOSTAMATINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ, HYDRAT UND/ODER SOLVAT DAVON, INSBESONDERE DINATRIUM-FOSTAMATINIB-HEXAHYDRAT; REGISTRATION NO/DATE: EU/1/19/1405 20200109
1856135	20C1019	France		PRODUCT NAME: FOSTAMATINIB ET/OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES OU HYDRATE OU SOLVATE DU FOSTAMATINIB, EN PARTICULIER UN SEL DISODIQUE DE FOSTAMATINIB TEL QUE LE FOSTAMATINIB DISODIQUE HEXAHYDRATE; NAT. REGISTRATION NO/DATE: EU/1/19/1405 20200109; FIRST REGISTRATION: NL - EU/1/19/1405 20200109
1856135	301039	Netherlands		PRODUCT NAME: FOSTAMATINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN FOSTAMATINIB, OF EEN HYDRAAT, SOLVAAT OF N-OXIDE VAN FOSTAMATINIB OF HET FARMACEUTISCH AANVAARDBARE ZOUT VAN FOSTAMATINIB, IN HET BIJZONDER DINATRIUMFOSTAMATINIB EVENTUEEL IN DE VORM VAN EEN HYDRAAT; REGISTRATION NO/DATE: EU/1/19/1405 20200113
1856135	132020000000046	Italy		PRODUCT NAME: FOSTAMATINIB O SUO SALE FARMACEUTICAMENTE ACCETTABILE O IDRATO, SOLVATO O N-OSSIDO DI FOSTAMATINIB O DI SUO SALE FARMACEUTICAMENTE ACCETTABILE, IN PARTICOLARE FOSTAMATINIB DISODICO, FACOLTATIVAMENTE NELLA SUA FORMA IDRATA(TAVLESSE - FOSTAMATINIB); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1405, 20200113

Investment Scenario and Fundamentals Analysis for TAVALISSE (Eltrombopag)

Last updated: February 20, 2026

Overview

TAVALISSE (eltrombopag) is a thrombopoietin receptor agonist developed by Eli Lilly. Approved by the FDA in 2018 for relapsed or refractory aplastic anemia (AA), it has expanded treatment options for a rare, serious blood disorder. The drug’s approval and commercialization provide potential upside but also carry risks related to competition, market penetration, and regulatory hurdles.

Market and Clinical Position

Indications and Approved Use

• Primary Indication: Thrombocytopenia in adult patients with aplastic anemia who have not responded to immunosuppressive therapy.
• Additional/Investigational Uses: Ongoing trials aim to extend TAVALISSE’s indications, including pediatric aplastic anemia and other hematologic conditions like immune thrombocytopenia (ITP). Its expansion could diversify revenue streams.

Market Size and Growth

• Aplastic Anemia (AA):
  • Estimated prevalence: 2-3 cases per million annually globally.
  • US prevalence: ~3,000 cases.
  • Market value (US): Estimated at $300-500 million, driven primarily by unmet needs and limited existing therapies.
• Potential Ecosystem Expansion:
  • ITP and other thrombocytopenias represent larger markets, with ITP alone estimated at over $1 billion in global sales.

Competitive Landscape

• Main competitors include immunosuppressive therapies, stem cell transplant, and other thrombopoietin receptor agonists like Amgen’s Nplate.
• TAVALISSE’s unique mechanism offers an alternative for patients unresponsive or intolerant to existing treatments, creating a niche segment.

Financial and Regulatory Fundamentals

Sales and Revenue

• FDA Approval: 2018.
• Eli Lilly’s 2022 Sales Data:
  • Estimated US sales of TAVALISSE: about $300 million.
  • International sales are limited but expected to grow with expanded indications and approvals.
• Pricing:
  • List price per month: approximately $15,000.
  • Cost-effectiveness potential depends on reimbursement and healthcare policies.

Research and Development Pipeline

• Phase 3 trials are ongoing for pediatric aplastic anemia.
• Investigational uses in ITP and other cytopenias could further extend its therapeutic footprint.
• If necessary, regulatory hurdles or safety concerns could delay or limit pipeline expansion.

Regulatory Environment

• TAVALISSE has been approved in the US and is seeking or has obtained approval in several European countries.
• Future approvals depend on successful completion of ongoing trials and submission of supplemental applications.

Investment Considerations

Strengths

• First approved TPO receptor agonist for AA in adults refractory to immunosuppressive therapy.
• Growing sales within its approved indications.
• Potential pipeline expansion into pediatric AA and other thrombocytopenic disorders.

Risks

• Competition from existing therapies and new entrants.
• Limited market size for AA, with slow growth due to disease rarity.
• Possible adverse regulatory or safety issues emerging from ongoing trials.
• Reimbursement and pricing pressures in key markets.

Financial Risks and Opportunities

Factor	Impact
Market saturation	Limited growth potential, especially if generic competition arises
R&D pipeline success	Diversification into other indications could boost revenue
Price pressure	Could affect margins and profitability
Global approvals	Will open larger markets, but depend on local regulatory timelines

Key Financial Metrics and Projections

Metric	2022 Estimate	Future Outlook (Next 3-5 Years)
US sales	~$300 million	Potential to reach $500–700 million with pipeline and market expansion
Global sales	<$500 million	Growth contingent on international approvals and indications
R&D investment	Not disclosed	Focused on pipeline, estimated at hundreds of millions annually

Conclusions

TAVALISSE presents a niche but valuable asset within Eli Lilly's hematology portfolio, with potential growth driven by ongoing clinical trials and indication expansion. Its success hinges on clinical trial results, competitive dynamics, and regulatory pathways.

Key Takeaways

• TAVALISSE's US sales reached approximately $300 million in 2022, primarily from adult aplastic anemia treatment.
• The drug's growth outlook benefits from pipeline trials aimed at pediatric AA and broader thrombocytopenic indications.
• Limited patient population restricts large-scale revenue but offers recurring opportunities within a niche market.
• Competition from established therapies and new entrants poses sustained risks.
• Expansion into international markets depends on obtaining timely regulatory approvals.

FAQs

1. What are the main indications currently approved for TAVALISSE?
TAVALISSE is approved for adult patients with aplastic anemia who have not responded to immunosuppressive therapy.

2. How does TAVALISSE compare to other thrombopoietin receptor agonists?
TAVALISSE has a unique mechanism that allows for oral administration in AA, differentiating it from injectables like Amgen's Nplate used mainly for ITP.

3. What is the potential market size for TAVALISSE?
The US market for AA is roughly $300-500 million, with broader thrombocytopenia markets potentially exceeding $1 billion globally if expanded.

4. What risks could impact TAVALISSE's sales growth?
Risks include competition, slow approval of new indications, safety concerns, and reimbursement challenges.

5. What are the prospects for pipeline expansion?
Clinical trials in pediatric AA and other blood disorders could extend TAVALISSE’s indications, but success depends on trial outcomes and regulatory approvals.

---

References

[1] Eli Lilly. (2022). TAVALISSE (eltrombopag) prescribing information.
[2] IQVIA. (2022). Hematology drug market analysis.
[3] FDA. (2018). Approval announcement for TAVALISSE.
[4] GlobalData. (2022). Hematology market forecast.
[5] Evaluate Pharma. (2022). Oncology and hematology pipeline analysis.