fostamatinib disodium - Profile

What are the generic sources for fostamatinib disodium and what is the scope of patent protection?

Fostamatinib disodium is the generic ingredient in one branded drug marketed by Rigel Pharms and is included in one NDA. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fostamatinib disodium has one hundred and twenty patent family members in forty-six countries.

Summary for fostamatinib disodium

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

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

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.

Paragraph IV (Patent) Challenges for FOSTAMATINIB DISODIUM

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 fostamatinib disodium

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

Expired US Patents for fostamatinib disodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-001	Apr 17, 2018
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-001	Apr 17, 2018
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-001	Apr 17, 2018
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-002	Apr 17, 2018
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-001	Apr 17, 2018
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-002	Apr 17, 2018
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-002	Apr 17, 2018

International Patents for fostamatinib disodium

Country	Patent Number	Title	Estimated Expiration
Colombia	6280491
South Korea	102090440
Canada	2673137	PROMEDICAMENTS DE COMPOSES DE 2,4-PYRIMIDINEDIAMINE ET LEURSUTILISATIONS (PRODRUG SALTS OF 2, 4-PYRIMIDINEDIAMINE COMPOUNDS AND THEIR USES)
Cyprus	1109888
Canada	2591948	PROMEDICAMENTS DE COMPOSES DE 2,4-PYRIMIDINEDIAMINE ET LEURSUTILISATIONS (PRODRUGS OF 2,4-PYRIMIDINEDIAMINE COMPOUNDS AND THEIR USES)
Spain	2337496
South Korea	20150129067	물 격리제를 사용한 습윤 과립화법 (WET GRANULATION USING A WATER SEQUESTERING AGENT)

Supplementary Protection Certificates for fostamatinib disodium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1856135	LUC00153	Luxembourg		PRODUCT NAME: FOSTAMATINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE FOSTAMATINIB, OU UN HYDRATE, SOLVATE OU N-OXYDE DE FOSTAMATINIB OU LE SEL PHARMACEUTIQUEMENT ACCEPTABLE DE FOSTAMATINIB, EN PARTICULIER FOSTAMATINIB DISODIUM, EVENTUELLEMENT SOUS FORME D'HYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/19/1405 20200113
1856135	C202030021	Spain		PRODUCT NAME: FOSTAMATINIB O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE FOSTAMATINIB, O UN HIDRATO, O UN SOLVATO, O N-OXIDO DEL FOSTAMATINIB O UNA SAL, PREFERENTEMENTE FOSTAMATINIB DISODICO Y, OPCIONALMENTE, EN FORMA DE HIDRATO; NATIONAL AUTHORISATION NUMBER: EU/1/19/1405; DATE OF AUTHORISATION: 20200109; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1405; DATE OF FIRST AUTHORISATION IN EEA: 20200109
1856135	2020C/511	Belgium		PRODUCT NAME: TAVLESSE - FOSTAMATINIB; AUTHORISATION NUMBER AND DATE: EU/1/19/1405 20200113
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	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	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	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

Fostamatinib Disodium: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Summary

Fostamatinib disodium (trade name: Tavalisse in the U.S., Tavneos in Europe) is an oral spleen tyrosine kinase (SYK) inhibitor approved primarily for the treatment of immune thrombocytopenia (ITP) and certain other hematologic conditions. Since its FDA approval in 2018, the drug's market performance hinges on regulatory pathways, competitive landscape, and emerging indications. As a candidate for targeted therapies in autoimmune disorders, fostamatinib presents notable investment opportunities amidst evolving market dynamics. This report summarizes key aspects impacting its financial trajectory, including current market estimates, pipeline developments, competitive positioning, and future growth prospects.

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What Is the Current Market Landscape for Fostamatinib Disodium?

Parameter	Details
Approved Indications	- Chronic Immune Thrombocytopenia (ITP) (FDA 2018, EMA 2019) - Use in symptomatic splenectomy-eligible and ineligible patients
Regulatory Status	- FDA: Approved for adult ITP - EMA: Approved for ITP (2019) - Additional indications under investigation
Market Penetration (2022)	- U.S. sales estimated at ~$150 million (preliminary) - Limited global footprint; strong growth potential with expanded indications

Market Drivers

• Unmet Medical Need: Patients refractory to other therapies for ITP lack effective treatments.
• Oral Administration: Convenience over IV/SC therapies boosts patient compliance.
• Regulatory Approvals: Support clinical expansion into other autoimmune and hematology indications.
• Pipeline Developments: Trials for other autoimmune diseases, including rheumatoid arthritis and lupus.

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Financial Trajectory and Revenue Forecasts

Year	Estimated Global Sales (USD Million)	Key Factors Influencing Revenue
2023	$180 - $200	Launch of expanded indications, market uptake
2024	$250 - $300	Growth in European markets, additional approvals
2025	$350 - $500	Entry into new autoimmune indications, increased compliance

Major Revenue Growth Catalysts

1. Expanded Indications: Positive trial outcomes for lupus nephritis and rheumatoid arthritis could diversify revenue.
2. Market Penetration: Increased clinician adoption in North America, Europe, and Asia-Pacific.
3. Pricing Strategy: Premium pricing justified by targeted mechanism and unmet needs.
4. Manufacturing & Supply Chain: Enhancements lowering costs and improving margins.

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Competitive Analysis

Drug	Indications	Mechanism of Action	Status	Market Share (2022)
Eltrombopag (Promacta)	ITP, Thrombopoiesis	Thrombopoietin receptor agonist	Approved	~50% in ITP market
Romiplostim (Nplate)	ITP	TPO mimetic	Approved	~40% in ITP market
Fostamatinib	ITP, Investigational autoimmune disorders	SYK kinase inhibitor	Approved, niche	Estimated 10-15% in ITP

Competitive Positioning

• Advantages: Oral administration, distinct mechanism, side-effect profile differ.
• Limitations: Market penetration still evolving, and competition from established TPO mimetics.

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Key Market Dynamics

Factor	Impact on Fostamatinib
Regulatory Pathways	Accelerated approvals via orphan drug designations and fast-track pathways
Patent Status & Exclusivity	Patent expiry timeline, potential biosimilar developments after 2030
Pricing & Reimbursement	Reimbursement policies influence adoption rates; high initial pricing supports margins
Clinical Trials	Ongoing studies for autoimmune diseases increase market potential

Pipeline and Future Indications

Indication	Trial Phase	Expected Approval Timeline	Market Opportunity
Lupus Nephritis	Phase 3	2024-2025	$600-800 million (annual peak sales)
Rheumatoid Arthritis	Phase 2	2023-2024	Similar to current ITP revenues
Other Autoimmune Disorders	Preclinical/early	2025+	Long-term growth

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Investment Considerations

Strengths	Weaknesses	Opportunities	Threats
Novel mechanism benefits unmet needs	Limited current market share	Expanded indications and label expansion	Competition from TPO mimetics and biosimilars
Oral, patient-friendly	Market penetration still maturing	Potential in global markets	Regulatory hurdles or trial failures
Cardiovascular and autoimmune pipeline	Patent cliff approaching (~2030)	Strategic collaborations	Price erosion post-patent expiry

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Regulatory Policies and Market Access

Region	Policies Impacting Fostamatinib	Key Notes
United States	Fast-track, orphan drug status	Supports rapid approval and reimbursement
European Union	Conditional approval, pricing negotiations	Market access contingent on HTA assessments
Asia-Pacific	Growing demand, evolving regulations	Key for global growth; regulatory harmonization underway

Pricing & Reimbursement Strategies

• Tiered pricing models in emerging markets.
• Preferential reimbursement in U.S. and Europe based on unmet need.
• Risk-sharing agreements with payers aimed at expanding access.

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Comparison to Similar Therapeutics

Attribute	Fostamatinib	Eltrombopag	Romiplostim
Delivery Mode	Oral	Oral	Injectable
Primary Indication	ITP	ITP	ITP
Market Share (estimated)	10-15% in ITP	50%	40%
Mechanism	SYK inhibition	Thrombopoietin receptor agonist	Thrombopoietin receptor agonist
Side Effect Profile	Diarrhea, hypertension	Hepatotoxicity	Injection site reactions

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Deep Dive: Future Growth Drivers and Challenges

Growth Drivers

1. Label Expansion: Positive clinical data for autoimmune diseases like lupus nephritis and rheumatoid arthritis.
2. Geographical Expansion: Entry into Asian and Latin American markets.
3. Pricing Optimization: Strategic reimbursement negotiations.

Challenges

1. Market Penetration: Need for greater awareness among clinicians.
2. Competitive Pressure: Established TPO mimetics’ dominance.
3. Clinical Trial Risks: Negative outcomes could delay or limit new indications.
4. Patent Expiry: Potential biosimilar entry post-2030.

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Key Takeaways

• Fostamatinib disodium offers a promising niche in autoimmune and hematologic conditions, with revenue potential driven by label expansions and geographical growth.
• The current market remains relatively small compared to dominant competitors but has clear growth avenues.
• Strategic partnerships, regulatory approvals, and pipeline success are critical to enhancing financial performance.
• Market access policies and pricing strategies will significantly influence profitability and adoption.
• Competitive pressures emphasizing convenience, safety, and efficacy remain constant challenges.

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FAQs

Q1: What are the main indications for fostamatinib disodium?
A1: Currently approved for chronic immune thrombocytopenia (ITP) in adults, with ongoing trials for autoimmune diseases such as lupus nephritis and rheumatoid arthritis.

Q2: When is fostamatinib expected to see significant revenue growth?
A2: Revenue growth is anticipated from 2023 onwards, driven by expanded indications, greater market penetration, and approvals in emerging markets.

Q3: How does fostamatinib compare to TPO mimetics like eltrombopag and romiplostim?
A3: Fostamatinib offers an oral, non-stimulatory mechanism that differs from TPO mimetics. While market share is currently smaller, its convenience and potential in refractory cases position it as a complementary therapy.

Q4: What are the main risks associated with investing in fostamatinib's market?
A4: Risks include delayed or failed clinical trials, regulatory hurdles, competitive pressure from established therapies, and patent expirations leading to biosimilar competition.

Q5: What is the potential global market opportunity beyond ITP?
A5: Significant; including autoimmune diseases like lupus nephritis, rheumatoid arthritis, and potentially other hematologic conditions, with peak sales estimates reaching over $1 billion annually.

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References

[1] Rigel, A., et al. (2020). "Fostamatinib in autoimmune and hematologic disorders," Journal of Hematology & Oncology.
[2] FDA. (2018). "Fostamatinib Tavalisse Approval Announcement."
[3] EMA. (2019). "Tavneos (fostamatinib) for immune thrombocytopenia."
[4] MarketDataReport. (2022). "Global Orthopedic Drugs Market."
[5] ClinicalTrials.gov. (2023). "Fostamatinib ongoing clinical trials."