Fostamatinib disodium - Generic Drug Details

What are the generic drug 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.

One supplier is listed for this compound.

Summary for fostamatinib disodium

International Patents:	120
US Patents:	14
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	19
Patent Applications:	334
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fostamatinib disodium
DailyMed Link:	fostamatinib disodium at DailyMed

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

Constraining patent/regulatory exclusivity:

8,771,648

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.

Recent Clinical Trials for fostamatinib disodium

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Rigel Pharmaceuticals	Phase 3
AstraZeneca	Phase 2
AstraZeneca	Phase 3

See all fostamatinib disodium clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for fostamatinib disodium

B02BX	Other systemic hemostatics
B02B	VITAMIN K AND OTHER HEMOSTATICS
B02	ANTIHEMORRHAGICS
B	Blood and blood forming organs

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	209299-002	Apr 17, 2018		RX	Yes	Yes	9,266,912
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-002	Apr 17, 2018		RX	Yes	Yes	7,538,108			Y
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-002	Apr 17, 2018		RX	Yes	Yes	8,263,122		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	209299-002	Apr 17, 2018	8,912,170
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-001	Apr 17, 2018	8,211,889
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-001	Apr 17, 2018	8,912,170

International Patents for fostamatinib disodium

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

Supplementary Protection Certificates for fostamatinib disodium

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	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	2020/017	Ireland		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; REGISTRATION NO/DATE: EU/1/19/1405 20200113

Market Dynamics and Financial Trajectory for Fostamatinib Disodium

Last updated: February 20, 2026

Fostamatinib disodium, marketed as Tavalisse, targets immune thrombocytopenia (ITP) and is developed by Rigel Pharmaceuticals. Its market landscape is shaped by FDA approval, competitive landscape, pricing strategies, and evolving indications.

Regulatory Approval and Market Entry

• FDA Approval: Approved in April 2018 for chronic immune thrombocytopenia (ITP) in adults who have failed other treatments.
• EMA Status: Not approved in European Union.
• Additional Indications: Potential expansion into other autoimmune conditions is under investigation, which could influence market size.

Market Size and Demand Drivers

• Global ITP Market Estimate: Valued around $1 billion in 2022, projected to grow at approximately 8% CAGR through 2030.[1]
• Patient Population: Estimated 60,000–70,000 adult patients in the U.S. with chronic ITP.
• Unmet Needs: Limited options post standard therapies, delivering growth potential.

Competitive Landscape

Product	Mechanism	Status	Approximate US Sales (2022)
Fostamatinib (Tavalisse)	Spleen tyrosine kinase (Syk) inhibition	Approved in 2018	$30 million
Romiplostim (Nplate)	Thrombopoietin receptor agonist	Market leader, approved	$320 million
Eltrombopag (Promacta)	Thrombopoietin receptor agonist	Approved in 2008	$720 million

• Fostamatinib faces competition primarily from thrombopoietin receptor agonists, which hold majority market share.
• It benefits from a different mechanism, offering an alternative for patients intolerant to TPO stimulators.

Pricing and Reimbursement

• Pricing Strategy: Approximately $15,000 per patient annually.
• Reimbursement Landscape: Insurance coverage varies; payers favor TPO agents due to higher efficacy reports but may consider fostamatinib for refractory cases.
• Cost-Effectiveness: Limited data; potential for price adjustments as more real-world evidence emerges.

Revenue Trajectory and Financial Outlook

• Initial Sales: $12-$15 million in 2022; growth dependent on wider adoption and label expansion.

• Sales Drivers:

  • Increase in diagnosed adult ITP cases.
  • Physician familiarity and comfort with fostamatinib's distinctive mechanism.
  • Expansion into additional autoimmune INDICATIONS.

• Challenges:

  • Competition from established TPO agents.
  • AUC (average unit cost) pressures.
  • Patient tolerability concerns.

• Forecast: Anticipated revenue growth at a compound annual rate of about 10% through 2027, reaching an estimated $60 million.

Development Pipeline and Future Opportunities

• New Indications: Investigation for autoimmune hemolytic anemia and other immune-mediated disorders could diversify revenue.
• Biomarker Identification: Improving patient selection may enhance outcomes and adoption.

Key Risks and Opportunities

Risks	Opportunities
Competitive pressure	Expansion into additional indications
Slow uptake post-launch	Demonstrating efficacy in refractory patients
Cost containment pressures	Strategic pricing and reimbursement negotiations

Summary

Fostamatinib disodium remains a niche player in a dominant TPO agonist space. Its growth relies on expanding indications, improving market penetration, and differentiating in efficacy and tolerability profiles.

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Key Takeaways

• Fostamatinib’s U.S. sales totaled approximately $30 million in 2022.
• It faces strong competition from TPO receptor agonists, which are more widely used.
• Market growth forecasts suggest a 10% CAGR through 2027, driven by new indications and increasing awareness.
• Pricing remains steady, with potential upward adjustments aligned with clinical milestones.
• Future success depends on expanding indications and demonstrating clinical benefits in refractory patient groups.

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FAQs

1. What are the main challenges for fostamatinib's market expansion?
Competition from dominant TPO receptor agonists, limited approval scope, and insurance coverage variability.

2. Are there any ongoing trials for additional indications?
Yes, investigational studies target autoimmune hemolytic anemia and other autoimmune conditions, which could broaden its market.

3. How does fostamatinib compare with TPO agents in terms of efficacy?
Efficacy varies; fostamatinib is often considered for patients intolerant to TPO agents or refractory cases, but head-to-head data is limited.

4. What pricing strategies might influence future revenue?
Maintaining competitiveness through cost negotiations and value-based pricing aligned with clinical benefits.

5. What is the long-term potential for fostamatinib?
Expansion into new indications, improved patient outcomes, and increased physician familiarity could significantly enhance its market share.

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References

1. MarketResearch.com. (2022). Global Immune Thrombocytopenia Market Size and Forecast.