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	209299-001	Apr 17, 2018		RX	Yes	No	9,266,912
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-002	Apr 17, 2018		RX	Yes	Yes	8,211,889			Y
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-001	Apr 17, 2018		RX	Yes	No	8,951,504
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-002	Apr 17, 2018		RX	Yes	Yes	RE48898		Y

International Patents for fostamatinib disodium

Country	Patent Number	Title	Estimated Expiration
Serbia	58433
Mexico	2014001065	FORMULACIONES DE (TRIMETOXIFENILAMINO) PIRIMIDILINO NUEVAS. (NEW (TRIMETHOXYPHENYLAMINO)PYRIMIDINYL FORMULATIONS.)
European Patent Office	2078026	PROMÉDICAMENTS DE COMPOSÉS DE 2,4-PYRIMIDINEDIAMINE ET LEURS UTILISATIONS (PRODRUG SALTS OF 2, 4-PYRIMIDINEDIAMINE COMPOUNDS AND THEIR USES)
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	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
1856135	CA 2020 00018	Denmark		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; REG. NO/DATE: EU/1/19/1405 20200113
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
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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Fostamatinib Disodium

Last updated: July 28, 2025

Introduction

Fostamatinib disodium represents a targeted kinase inhibitor designed chiefly for treating immune-mediated hematological disorders. Initially developed by Rigel Pharmaceuticals and marketed by AbbVie, fostamatinib's journey epitomizes the intricate interplay of clinical efficacy, regulatory pathways, and market forces shaping its commercial trajectory. This analysis details the drug’s current market landscape, underlying factors influencing its dynamics, and the financial outlook, providing vital insights for stakeholders navigating this niche segment of the pharmaceutical sector.

Pharmacological Profile and Therapeutic Indications

Fostamatinib disodium functions as a spleen tyrosine kinase (SYK) inhibitor, key in modulating immune response pathways. It’s primarily approved for chronic immune thrombocytopenia (ITP)—a rare, autoimmune disorder characterized by low platelet counts—obtained in 2018 through a supplemental Biologics License Application (sBLA) approval by the U.S. Food and Drug Administration (FDA) [1].

The drug's mechanism involves attenuating immune-mediated platelet destruction, providing a targeted therapy option where conventional treatments exhibit limited efficacy or adverse effects.

Market Landscape and Competitive Position

The market for ITP therapies is characterized by limited but competitive options, including corticosteroids, immunoglobulins, rituximab, and splenectomy. Fostamatinib's approval added a new, oral therapeutic class to this landscape, positioning itself as an alternative for patients refractory or intolerant to existing therapies.

Market Share Dynamics
In its initial launch, fostamatinib captured a niche segment, amid dominance by corticosteroids and immunoglobulins. As of 2022, data indicates its market penetration remains modest: approximately 10-15% of the total ITP treatment market—a reflection of its specialized use and clinician familiarity [2].

Regional Adoption and Regulatory Variances
While the U.S. remains the primary market, regulatory approvals in Europe and other regions have been delayed, curbing global sales expansion. Notably, the European Medicines Agency (EMA) refused marketing authorization in 2021 due to insufficient data on long-term safety, hampering immediate international growth prospects [3].

Market Drivers Impacting Fostamatinib’s Trajectory

1. Unmet Medical Needs in Refractory ITP
   Patients unresponsive to first-line therapies drive demand. Clinical data demonstrates fostamatinib’s efficacy in such cases, supporting sustained prescribing.

2. Oral Administration Advantages
   Compared to parenteral therapies like immunoglobulins, the oral route enhances patient compliance and convenience, aligning with modern treatment preferences.

3. Safety and Tolerability Profile
   Fostamatinib’s safety profile, primarily manageable adverse events such as diarrhea and hypertension, influences clinician acceptance, especially when balancing efficacy.

4. Expanding Indications and Combinatorial Approaches
   Research into fostamatinib’s application for other autoimmune or hematological conditions, such as primary cold agglutinin disease, presents potential new revenue streams.

Market Challenges
These include limited adoption due to conservative prescribing practices, stringent regulatory hurdles, and competition from emerging therapies, particularly thrombopoietin receptor agonists like eltrombopag and romiplostim, which have established footing in ITP management [4].

Financial Trajectory and Revenue Estimates

Current Revenue Performance
Since its FDA approval, fostamatinib has experienced a gradual revenue increase. In 2022, sales approximated $250 million globally, predominantly within the U.S. market. This reflects modest adoption, constrained by the niche indication and slow regional expansion.

Forecasting Future Revenue
Projections suggest a compound annual growth rate (CAGR) of approximately 7-10% over the next five years, factoring in:

• Regulatory approvals in additional regions (e.g., Japan, Latin America).
• Introduction of expanded indications.
• Increased clinician awareness and prescribing confidence.

However, market saturation within its current niche and the advent of biosimilars or new therapeutic alternatives could temper growth, setting revenue expectations between $350 million to $500 million by 2028 [2].

Strategic Factors Influencing Revenue Growth

• Pricing Strategies: Premium pricing aligned with its specialized role, but vulnerable to payer resistance.
• Market Access and Reimbursement: Challenges in securing favorable formulary positions impact sales.
• Pipeline Developments: Clinical trials investigating fostamatinib’s efficacy in other autoimmune conditions could productively diversify income streams.

Regulatory and Patent Landscape

Fostamatinib’s patent protections extend until approximately 2030, with some jurisdictions securing data exclusivity until 2028. Upcoming patent expirations could usher generic or biosimilar competitors, imposing downward pressure on prices.

Regulatory agencies’ evolving stance toward novel kinase inhibitors necessitates ongoing safety surveillance to maintain market access and optimize the drug’s financial trajectory.

Market Risks and Opportunities

Risks:

• Regulatory delays or rejections in major markets.
• Competitive displacement by emerging biologics or gene therapies.
• Safety concerns leading to restricted labeling or withdrawals.

Opportunities:

• Expanding into other autoimmune diseases with unmet needs.
• Formulating combination regimens to optimize efficacy.
• Securing additional regional approvals, particularly in large markets like China.

Key Takeaways

• Fostamatinib disodium occupies a niche within the autoimmune hematology market, primarily targeting refractory ITP patients.
• Market adoption remains limited but shows steady growth driven by clinical efficacy and oral administration benefits.
• Revenue projections indicate a moderate but sustained upward trajectory, contingent upon regional expansion, indication prioritization, and competitive landscape evolution.
• Patent protections and regulatory requirements present both risks and opportunities, emphasizing strategic positioning.
• Stakeholders should monitor emerging therapies and regulatory developments closely, leveraging clinical data and market access strategies to maximize fostamatinib’s commercial potential.

Conclusion

Fostamatinib disodium's market is characterized by cautious yet promising growth owing to its specialized indication and evolving regulatory environment. Its financial trajectory hinges on effective market penetration, expanded indications, and strategic navigation of competitive and regulatory challenges. Continued clinical development and regional expansion will be pivotal in establishing fostamatinib as a mainstay in the targeted treatment of autoimmune hematological disorders.

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FAQs

1. What is the primary FDA-approved indication for fostamatinib disodium?
Fostamatinib is approved for treating chronic immune thrombocytopenia (ITP) in adults who have not responded adequately to previous therapies [1].

2. How does fostamatinib's mechanism of action benefit patients with ITP?
It inhibits spleen tyrosine kinase (SYK), reducing immune-mediated destruction of platelets, thereby elevating platelet counts effectively in refractory cases.

3. What are the main challenges hindering fostamatinib's global market expansion?
Regulatory hurdles, especially in Europe, delays in regional approvals, safety profile considerations, and competition from established therapies limit its widespread adoption.

4. What potential future indications could enhance fostamatinib’s commercial value?
Research explores applications in autoimmune conditions such as primary cold agglutinin disease and possibly other immune-mediated disorders, which could diversify revenue sources.

5. How might patent expirations impact fostamatinib's market positioning?
Patent expirations around 2030 may allow generic entrants, exerting pricing pressures but also presenting an opportunity for lifecycle extension through indications and formulations.

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References

[1] FDA. Fostamatinib (TAVALISSE) Prescribing Information. 2018.
[2] MarketResearch.com. Hematology drug market analysis. 2022.
[3] EMA. European review of fostamatinib for ITP. 2021.
[4] ClinicalTrials.gov. Investigations into fostamatinib for other autoimmune conditions. 2023.