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^® Litigation and Generic Entry Outlook for Tavalisse

A generic version of TAVALISSE was approved as fostamatinib disodium by ANNORA PHARMA on June 17^th, 2026.

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.

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	AB	RX	Yes	Yes	8,771,648		Y
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-001	Apr 17, 2018	AB	RX	Yes	No	9,283,238
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-002	Apr 17, 2018	AB	RX	Yes	Yes	7,538,108			Y
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-002	Apr 17, 2018	AB	RX	Yes	Yes	8,445,485		Y
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-001	Apr 17, 2018	AB	RX	Yes	No	7,989,448			Y
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-001	Apr 17, 2018	AB	RX	Yes	No	7,538,108			Y
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-001	Apr 17, 2018	AB	RX	Yes	No	RE48898		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
Germany	602006010979

Supplementary Protection Certificates for TAVALISSE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1856135	C 2020 014	Romania		PRODUCT NAME: SUPPLEMENTARY PROTECTION CERTIFICATE; NATIONAL AUTHORISATION NUMBER: C 2020 014; DATE OF NATIONAL AUTHORISATION: RO; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 1856135; DATE OF FIRST AUTHORISATION IN EEA: 20220530
1856135	PA2020507	Lithuania		PRODUCT NAME: FOSTAMATINIBO DINATRIO HEKSAHIDRATAS; REGISTRATION NO/DATE: EU/1/19/1405 20200109
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	CR 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	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	2020C/511	Belgium		PRODUCT NAME: TAVLESSE - FOSTAMATINIB; AUTHORISATION NUMBER AND DATE: EU/1/19/1405 20200113
1856135	C20200009 00319	Estonia		PRODUCT NAME: FOSTAMATINIIB;REG NO/DATE: EU/1/19/1405 13.01.2020

Tavalisse (fostamatinib) investment scenario and fundamentals analysis: exclusivity, patent estate, FDA status, and revenue risk

Last updated: July 28, 2026

Executive summary: Tavalisse (fostamatinib) is a chronic, oral spleen tyrosine kinase (SYK) inhibitor approved for persistent/chronic immune thrombocytopenia (ITP). The investment case depends on (1) how long the current US regulatory exclusivity and patent estate delays non-infringing competition, (2) whether label expansion and real-world durability support continued net sales growth, and (3) competitive pressure from ITP agents that have entrenched hematology channel access. The key downside is accelerated entry risk if patent barriers erode or if biosimilar-like “functional switching” occurs among non-curative ITP drugs.

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What is Tavalisse (fostamatinib) and how is it positioned in chronic ITP?

Drug profile

• Brand: Tavalisse
• Generic name: fostamatinib
• Class: SYK inhibitor
• Route: oral
• Core therapeutic area: chronic immune thrombocytopenia (persistent/chronic ITP)
• Mechanism (investment relevance): Tavalisse targets downstream B-cell and Fc receptor signaling through SYK inhibition, reducing immune-mediated platelet destruction. In practice, commercial performance is driven by response durability, tolerability, and clinician switching patterns in a crowded ITP algorithm.

Where it fits clinically

• Typical ITP care pathways sequence chronic disease management after corticosteroids and immunoglobulins, then move to chronic therapies or thrombopoietin receptor agonists (TPO-RAs) and other non-curative options.
• Market adoption is shaped by the balance of efficacy versus adverse events and the degree of “fit” for patients who do not respond to, relapse on, or are not ideal candidates for TPO-RAs.

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What patents protect Tavalisse (fostamatinib) and how strong is the patent estate?

Featured snippet answer (patent estate strength) A complete, defensible patent-coverage map requires the Orange Book and patent family record tied to each US approved indication and dosage form. This response is not provided because the underlying patent publication and US listing set for Tavalisse is not supplied in the input data.

Patent estate elements investors track in ITP

1. Composition-of-matter (active ingredient): usually anchors long duration.
2. Formulation and polymorphs: can extend exclusivity through solid-state and excipient-specific IP.
3. Method-of-use: frequently protects dosing regimens or specific patient populations.
4. Manufacturing/processing: can create “process barriers” even if composition claims weaken.
5. Device or combination claims: in oncology-like areas this matters; in ITP it is less common, but still occurs with specific co-admin regimens.

Practical investment implication

• If composition claims expire first, but formulation or method-of-use claims remain, market entry can still be delayed for “true generics” but may be enabled for limited-label products or “workaround” label positions.
• Investors should model entry risk by product type: full generic versus label-limited generic versus settlement-based at-risk timing.

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When does Tavalisse lose exclusivity in the US?

Featured snippet answer Loss of exclusivity in the US is driven by the later of: patent expiration and any regulatory exclusivity periods tied to the original NDA and subsequent supplements. This response is not provided because the Orange Book listing dates and associated US patent expiration timeline are not included in the input.

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What is the Orange Book status of Tavalisse (fostamatinib)?

Featured snippet answer Orange Book status determines:

• which patents are listed for the relevant NDA,
• their listed expiration dates,
• whether listed patents are marked for “use” versus “drug substance/drug product,”
• and whether later supplements introduce new exclusivity tails.

This response is not provided because the Orange Book listing data is not present in the input.

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What generic entry risks exist for Tavalisse (fostamatinib)?

Entry risk model for chronically dosed ITP oral drugs Investors should separate:

• Regulatory entry risk (ANDA filing with Paragraph IV),
• Litigation risk (delay via infringement suits and automatic 30-month stays),
• Commercialization risk (label approval, payer adoption, and formulary switching).

Key commercial entry sensitivities

• Therapeutic substitution: switching from branded to generic depends on consistent tolerability and clinician confidence. In ITP, switching behavior can be sticky if patients stabilize on a drug.
• Payer dynamics: prior authorization and step therapy can blunt generic penetration even after approval.
• Safety labeling: if adverse events are a primary driver of adherence decisions, small formulation differences or bioequivalence uncertainty can affect prescribing behavior.

This response is not provided because the input lacks Tavalisse-specific Paragraph IV or ANDA litigation/filing history.

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What patent litigation affects Tavalisse (fostamatinib) and how do settlements impact timing?

Investment-relevant litigation mechanics

• Automatic stay: Paragraph IV infringement can trigger a 30-month stay of approval.
• Settlement agreements: can set “agreed launch dates,” often coupled with limitations on distribution channels, labeling, or stipulations of non-infringement for specific patents.
• Secondary disputes: enforcement of process or method-of-use claims can continue even if earlier composition claims weaken.

This response is not provided because no Tavalisse litigation docket, settlement terms, or date-specific procedural history is included in the input.

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How does Tavalisse (fostamatinib) compare with other chronic ITP therapies for commercialization risk?

Competitive landscape (how to think about it) Chronic ITP is an established, high-volume hematology market with multiple therapeutic classes:

• TPO-RAs (switching is common when efficacy is inadequate or safety limits adherence),
• BTK/SYK pathway drugs (where tolerability and response rates define share),
• Immunomodulatory approaches (used in selected patients and in combination strategies).

Investment comparison dimensions

• Time to response and durability
• Rate of discontinuation due to adverse events
• Real-world achievement of platelet targets
• Head-to-head or indirect evidence strength (used in payer and formulary decisions)
• Patient subgroups where SYK inhibition is favored

This response is not provided with quantified competitive market-share outcomes because the input contains no sales, payer, trial, or evidence metrics.

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What formulations are protected by and how do they affect biosimilar or generic feasibility?

Fostamatinib is a small molecule, so “biosimilar” is not the direct analogue risk. The relevant IP levers are:

• Drug product formulation IP: excipients, coating systems, or particle-size control
• Solid-state polymorph and salt form IP: can affect manufacturing and IP workarounds
• Stability and bioavailability-related IP: influences what is considered non-infringing

This response is not provided because the input does not include any formulation patent list or claim coverage for Tavalisse.

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What FDA pathway and regulatory milestones matter for Tavalisse investment?

Regulatory milestones investors track

• Original NDA approval date and label scope
• Changes via sNDA or PAS updates
• Safety communications that affect persistence and dose intensity
• Evidence of durable benefit via postmarketing trials

This response is not provided because the input contains no FDA milestone timeline, label history, or postmarketing commitments tied to Tavalisse.

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What revenue exposure exists for Tavalisse (fostamatinib) given ITP market dynamics?

Revenue exposure drivers

1. Channel penetration: hematologists and infusion center practices, plus specialty pharmacy distribution
2. Dose persistence: chronic therapy outcomes; discontinuation risk can reduce realized net sales
3. Formulary placement: payer policies can accelerate or block substitution
4. Seasonality or patient incident volume: chronic ITP is ongoing, but incident rate changes and referral patterns shift

This response is not provided because the input has no Tavalisse revenue history, guidance, net sales split by quarter, or payer coverage.

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How strong is the overall investment thesis for Tavalisse (fostamatinib) versus generic entry scenarios?

Base-case framework (what to model)

• Time-weighted entry window: when the first credible non-infringing version can launch
• Penetration ramp: speed to uptake post-approval
• Price erosion: typical generic compression depends on substitution barriers and channel structure
• Share shift: whether clinicians pivot to another branded option or stay within the class

Downside scenario framework

• earlier-than-expected launch due to:
  • invalidation of key claims,
  • narrow claim scope permitting “design-around,”
  • unfavorable settlement that brings generic earlier than expected.

Upside scenario framework

• new or expanded label indications
• stronger real-world persistence
• adverse-event profile that improves adherence relative to alternatives

This response is not provided with scenario probabilities or quantified downside/upside because the input lacks patent expiration dates, entry history, and financial metrics.

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Key Takeaways

• Tavalisse is a chronic oral SYK inhibitor in persistent/chronic ITP, so its value is driven by long-duration patient persistence and clinician/payer adoption.
• Investment risk hinges on the US patent and regulatory exclusivity timeline, especially any listed Orange Book patents that block generic substitution or non-infringing workarounds.
• Generic entry risk is not only legal but commercial: formulary design, prior authorization, and persistence can delay realized revenue erosion even after approval.
• This analysis cannot populate patent-expiration dates, Orange Book status, litigation timelines, or financial exposures because those data are not present in the input.

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FAQs

1. How do Orange Book drug-substance versus drug-product patents for Tavalisse affect generic launch design-around?
2. What Paragraph IV filing and 30-month stay history determines generic launch timing for fostamatinib?
3. Which ITP therapy classes most constrain Tavalisse share growth through payer step edits and formulary restrictions?
4. How do adverse-event-driven discontinuation rates in chronic ITP change the expected net sales persistence for fostamatinib?
5. What formulation and solid-state patent barriers typically slow generic manufacturing for oral small-molecule drugs like fostamatinib?

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References

1. (No cited sources were provided in the input.)