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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	165
Clinical Trials:	3
Patent Applications:	2,567
Drug Prices:	Drug price information for TAVALISSE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TAVALISSE
What excipients (inactive ingredients) are in TAVALISSE?	TAVALISSE excipients list
DailyMed Link:	TAVALISSE at DailyMed

See drug prices for TAVALISSE

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

Constraining patent/regulatory exclusivity:

8,771,648

NDA:

209299

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 TAVALISSE

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

Sponsor	Phase
Holdsworth House Medical Practice	Phase 2
Washington University School of Medicine	Phase 2
Rigel Pharmaceuticals	Phase 2

See all TAVALISSE clinical trials

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.

This potential generic entry date is based on patent 8,771,648.

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	8,771,648		Y
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-001	Apr 17, 2018		RX	Yes	No	9,283,238
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-002	Apr 17, 2018		RX	Yes	Yes	7,538,108			Y

Expired US Patents for TAVALISSE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-002	Apr 17, 2018	9,266,912
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-001	Apr 17, 2018	8,445,485
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-002	Apr 17, 2018	9,283,238

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

Supplementary Protection Certificates for TAVALISSE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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

Tavalisse (fostamatinib) Market Dynamics and Financial Trajectory: Pricing, Uptake, Segment Exposure, and Exclusivity-Driven Risk

Last updated: July 7, 2026

Tavalisse (fostamatinib) is a late-stage, oral spleen tyrosine kinase (SYK) inhibitor with commercialization concentrated in chronic immune thrombocytopenia (ITP). Financial trajectory is driven by (1) new patient acquisition in US commercial channels, (2) reimbursement durability and payer restrictions, (3) competition from other ITP thrombopoietin receptor agonists (TPORAs) and newer agents, and (4) patent and exclusivity expiry plus biosimilar and generic substitution risk only to the extent fostamatinib becomes substitutable. The core market swing factor is uptake durability after initial growth, since pricing resets and prior authorization tightening often cap incremental share.

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What are the market dynamics shaping Tavalisse revenue growth in ITP?

Core demand engine: Chronic ITP incidence and treatment pathways funnel patients into TPORAs and immunosuppressives, with SYK inhibition acting as an alternative after prior lines or when TPORAs are unsuitable. Tavalisse’s addressable market is defined less by overall ITP prevalence and more by:

• lines of therapy eligible for SYK inhibition
• payer criteria for oral kinase inhibitors
• speed of platelet response and tolerability profile in real-world practice
• physician preference shaped by prior TPORA exposure, discontinuation rates, and steroid-sparing goals

Channel structure and reimbursement friction are primary growth constraints.

• Oral specialty launches typically face early managed-care pushback through step edits, prior authorization, and quantity limits.
• Long-run revenue depends on payer acceptance after health technology assessment outcomes and claims evidence accumulate.

Clinical differentiation affects switching behavior, not first-line prescribing. Tavalisse is generally positioned after inadequate response to prior therapies. That means the commercial ceiling is determined by switching from TPORAs and immunomodulators rather than broad upfront use.

Key payer and access levers that typically move forecast error

• Prior authorization adoption and renewal policies
• Denial rates tied to platelet thresholds and documented prior therapy failures
• Step therapy sequences that increase time-to-start and reduce persistence
• Specialty pharmacy distribution coverage and copay assistance participation

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How has Tavalisse’s pricing and gross-to-net structure influenced financial trajectory?

Pricing power is constrained by specialty pharmacy rebate pressure and competing oral regimens. For late-life chronic indications, gross-to-net erosion usually comes from:

• manufacturer rebates to PBMs and national accounts
• specialty pharmacy incentive programs tied to formulary placement
• contracting differences across Medicare Part D, commercial employer groups, and state exchanges

Net sales trend sensitivity is high to contract renewals. When payer coverage loosens, net sales can step up quickly; when restrictions tighten, net sales growth can flatten or reverse even if prescriptions remain stable, due to refill denials and delayed starts.

Financial performance tends to be persistence-driven. In chronic ITP, churn is common if platelet response is partial or if adverse events trigger discontinuation. That converts adherence into revenue outcomes.

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Where does Tavalisse sit in the chronic ITP competitive landscape and how does that affect sales?

Main competitor set:

• TPORAs: eltrombopag (Promacta), avatrombopag (Doptelet), romiplostim (Nplate; peptide), and other class members depending on region and availability
• Other non-curative ITP agents used after prior therapy: rituximab in practice patterns, and immunosuppressive regimens
• Emerging competitors: additional oral and biologic options that compete for similar lines of therapy

Competitive effects on Tavalisse:

• TPORAs have broad payer familiarity and established formularies, often slowing switching into SYK inhibition.
• Physicians use Tavalisse as an alternative when TPORA response fails or when patient-specific tolerability issues arise.
• Contract placement often tracks with evidence generation around response durability and discontinuation rates.

What tends to happen when TPORAs strengthen formulary coverage

• Tavalisse net growth often decelerates because payer edits reduce eligible starts.
• Prescriptions may persist but starts and refills decline after the first contract renewal cycle.

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When does Tavalisse lose exclusivity, and what generic entry risks exist?

Exclusivity and patent cliffs in branded specialty oral drugs usually control long-run net sales more than near-term competition. For Tavalisse, the financial arc is shaped by:

• US composition-of-matter and formulation protection on fostamatinib
• method-of-use protection tied to chronic ITP treatment regimens
• exclusivity periods (statutory exclusivity and any patent-term adjustments where applicable) and the timing of expiration for the last blocking patent

Generic entry risk pathway (US):

• If a sponsor files an abbreviated application and submits a Paragraph IV certification against Orange Book-listed patents, automatic stays and litigation risk can delay entry.
• Without confirmed Orange Book listings and listed patent expiries for Tavalisse, an accurate entry date cannot be produced here.

Biosimilar risk: None is directly applicable because fostamatinib is a small molecule, not a biologic.

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What is the Orange Book status of Tavalisse, and how many patents cover it?

An Orange Book status assessment requires the current list of Orange Book patents for the Tavalisse NDA and their expiration dates, including:

• active ingredient (fostamatinib)
• dosage form and strength
• method-of-use and formulation patents
• patent numbers and assignees
• exclusivity and any relevant regulatory exclusivities

A complete, accurate patent-count and expiry table cannot be produced without the Orange Book listing record.

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What Tavalisse patent litigation affects commercialization timelines (Paragraph IV, settlements, stays)?

Patent litigation affects financial trajectory through delayed generic entry and through any settlement-defined launch carve-outs, including:

• stipulated entry dates
• agreed non-infringement positions
• “at-risk” launch timing after final judgments
• scope limits by dosage forms or strength

A litigation timeline cannot be produced accurately without confirmed case captions, parties, court dockets, and settlement terms tied to specific Orange Book patents for Tavalisse.

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How do formulation and method-of-use patents influence switching and competitive substitution?

In chronic ITP, method-of-use coverage can block some attempts at “design-around” by narrowing the label and restricting certain dosing or responder-defined regimens. Formulation patents can similarly delay generic substitution if a competitor cannot match:

• specific release characteristics (if any)
• excipient systems
• manufacturing process requirements

Without the actual patent list for Tavalisse in the Orange Book, the scope cannot be enumerated.

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What is Tavalisse’s FDA regulatory status, and how does label breadth drive market uptake?

Market impact of label breadth:

• broader or multiple indications expand addressable patients and reduce dependence on one subset
• label qualifiers (response requirements, prior therapy constraints) narrow covered population, increasing payer scrutiny

Tavalisse’s uptake is also shaped by real-world use consistency with label and guideline positioning in chronic ITP. A precise financial linkage depends on current label status, which is not fully specified in the prompt.

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How does Tavalisse’s revenue trajectory compare with other ITP drugs?

In chronic ITP, brand performance relative to competitors is typically driven by:

• net price versus rebate pressure
• persistence after initial response
• payer coverage breadth across national and regional formularies
• lines-of-therapy constraints that cap incremental share

A quantified comparison requires Tavalisse sales series and peer net sales or at least annual revenue figures for key TPORAs and competing agents, none provided here.

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What manufacturing and IP barriers affect biosimilar/generic feasibility for fostamatinib?

For small molecules, manufacturing IP and process claims can still slow generic entry:

• process-specific patents can delay generic scale-up
• impurity profile constraints can be enforced by regulatory requirements
• formulation-dependent manufacturing controls can increase development time

But without the patent portfolio for Tavalisse, manufacturing/process barrier specifics cannot be reliably stated.

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Key financial trajectory drivers to model for Tavalisse (forecast logic that investors use)

Even without numeric sales values, Tavalisse’s financial trajectory can be decomposed into model variables:

1. Eligible patient pool growth
   • ITP incidence and diagnosis trends
   • shifting guideline behavior toward oral agents
2. Share of starts
   • payer list placement and step edit rates
   • physician preference and prior TPORA switching
3. Time to discontinuation
   • platelet response kinetics
   • adverse event-related discontinuation and dose modifications
4. Net price trajectory
   • gross-to-net compression from contracting cycle outcomes
5. Exclusivity and patent protection
   • risk of “first-to-qualify” generics or authorized generics
   • litigation outcomes affecting launch timing

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Key Takeaways

• Tavalisse’s financial trajectory in chronic ITP depends primarily on payer access durability, persistence after initial platelet response, and switching behavior from TPORAs and immunosuppressive regimens.
• Long-run downside risk is concentrated in exclusivity and patent expiration dynamics plus any Paragraph IV challenges.
• A complete exclusivity, Orange Book, and litigation-driven launch-risk calendar cannot be produced from the information provided.

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FAQs

1) What payer criteria most commonly restrict Tavalisse coverage in chronic ITP?
Prior authorization requiring documented prior therapy failure, platelet thresholds, and evidence of chronicity typically drive denial and delay.

2) Does Tavalisse compete more on efficacy or tolerability in ITP switching decisions?
Switching is usually driven by patient-specific tolerability and response considerations after TPORA or immunotherapy limitations.

3) What is the main financial risk if Tavalisse formulary placement worsens?
Reduced eligible starts and delayed refills can depress net sales even if prescriptions remain steady.

4) How should investors incorporate patent cliff risk for a small molecule like fostamatinib?
Use an “at-risk launch” framework tied to the last Orange Book blocking patent expiry and any Paragraph IV litigation outcomes.

5) What signals indicate Tavalisse is gaining versus losing share in ITP?
Shifts in prescription-to-start conversion, persistence/refill rates, and formulary coverage expansion or contraction.

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References

(No sources were provided or cited in the prompt; therefore no references can be listed.)

DrugChatter Q&A for TAVALISSE

How does Tavalisse treat low platelet counts?