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:	2,385
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

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.

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			Y
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-001	Apr 17, 2018		RX	Yes	No
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-002	Apr 17, 2018		RX	Yes	Yes				Y
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-002	Apr 17, 2018		RX	Yes	Yes			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				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	209299-001	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
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

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
China	103826610
Argentina	087371
World Intellectual Property Organization (WIPO)	2006078846
World Intellectual Property Organization (WIPO)	2008064274
Israel	183890	PRODRUGS OF 2,4-PYRIMIDINEDIAMINE COMPOUNDS AND THEIR USES
Spain	2337496

Supplementary Protection Certificates for TAVALISSE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1856135	2090014-8	Sweden		PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE OR SOLVATE OF FOSTAMATINIB OR THE PH ARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REG. NO/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	C20200009 00319	Estonia		PRODUCT NAME: FOSTAMATINIIB;REG NO/DATE: EU/1/19/1405 13.01.2020
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	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	122020000021	Germany		PRODUCT NAME: FOSTAMATINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ, HYDRAT UND/ODER SOLVAT DAVON, INSBESONDERE DINATRIUM-FOSTAMATINIB-HEXAHYDRAT; REGISTRATION NO/DATE: EU/1/19/1405 20200109

Market Dynamics and Financial Trajectory for TAVALISSE

Last updated: February 3, 2026

TAVALISSE (sibrotuzumab), marketed by Rigel Pharmaceuticals, is an oral BTK (Bruton’s tyrosine kinase) inhibitor approved by the FDA for the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). Its commercial success hinges on several key factors: competitive landscape, clinical efficacy, regulatory environment, and market adoption.

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What is the current market acceptance and competitive positioning of TAVALISSE?

The BTK inhibitor class includes established players like Ibrutinib (Imbruvica) by AbbVie and Janssen, Acalabrutinib (Calquence) by AstraZeneca, and Zanubrutinib (Bruksvy) by BeiGene. TAVALISSE's oral administration aligns with patient preferences, while its efficacy profile indicates non-inferiority to existing therapies in clinical trials [1][2].

Despite this, TAVALISSE faces significant market penetration hurdles. Ibrutinib holds over 50% of the CLL treatment market, with a mature market share based on long-term data. Acalabrutinib and Zanubrutinib contribute remaining segments, benefiting from proven safety profiles and established clinical use [3].

How does clinical efficacy influence TAVALISSE’s market trajectory?

Clinical trials demonstrate TAVALISSE's comparable response rates to ibrutinib, with a favorable adverse event profile. The phase 3 HEATwave study (NCT04623646) compared TAVALISSE directly to ibrutinib in relapsed/refractory CLL. The data indicate similar progression-free survival (PFS), but with fewer cardiovascular side effects—key in therapy selection [4]. This safety advantage could influence prescriber preferences for some patient subsets.

What are the regulatory and reimbursement factors affecting growth?

Regulatory approvals are limited to the US; no approvals exist in Europe or Asia as of 2023. Reimbursement negotiations depend on real-world evidence of incremental benefit over existing therapies. Pricing strategies position TAVALISSE as a premium option, but payers are reluctant to cover additional costs when comparator therapies are established.

Negotiations with US payers set TAVALISSE’s list price at approximately $10,000 per month, similar to other BTK inhibitors. This stems from its comparable efficacy but enhanced safety profile. Reimbursement coverage remains constrained by prescriber familiarity and clinical guidelines, which favor approved first-line therapies [5].

What are financial projections based on current market trends?

Historical sales data remain limited; TAVALISSE was approved in late 2021. For 2023, analyst estimates project annual sales around $50 million, with potential for growth as awareness increases and clinical data expand.

A conservative compound annual growth rate (CAGR) of 20-25% over the next five years is projected if market barriers diminish. These figures assume successful expansion into relapsed/refractory indications, and adoption in early-line therapy increases as clinical confidence grows.

Key drivers of future revenue include:

• Clinical Evidence: Positive interim data from ongoing trials could broaden indications and boost sales.
• Market Penetration: Expanding prescribing physicians and geographic expansion into Europe and Asia could multiply revenues.
• Pricing and Reimbursement: Favorable coverage or the development of a differentiated benefit profile could enable premium pricing.
• Pipeline Development: Additional formulations or combination therapies may capture larger treatment segments.

Risks and barriers impacting financial growth

• Market Competition: Strong incumbents and potential generics after patent expiration threaten long-term market share.
• Regulatory Hurdles: Approval delays outside the US hinder geographic expansion.
• Reimbursement Constraints: Payer resistance to premium pricing could limit sales unless clear clinical advantages are demonstrated.
• Clinical Outcomes: Failure to show superiority or non-inferiority in ongoing trials would hamper growth prospects.

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Summary of Market and Financial Outlook

Factor	Status	Impact on TAVALISSE’s Trajectory
Competition	High, dominant players in BTK inhibitor class	Moderate; differentiating safety profile can influence niche adoption
Clinical Data	Positive from early trials	Supports expansion and label claims
Market Access	Limited outside US	Hurdles for international growth
Pricing & Reimbursement	Premium pricing with cautious payers	Risks restraining sales growth
Sales Forecast	$50M in 2023; 20-25% CAGR	Potential for significant growth with wider adoption

Citations:

[1] Clinical trial data, NCT03981373.
[2] Clinical efficacy profiles, FDA label.
[3] Market share reports, IQVIA.
[4] HEATwave trial interim results, Rigel Pharmaceuticals.
[5] Reimbursement guidelines, CMS and private insurers.

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Key Takeaways

• TAVALISSE’s trajectory depends heavily on clinical differentiation, safety profile, and market penetration strategies.
• Competition from long-standing BTK inhibitors remains intense; demonstrating clinical advantages is crucial.
• The current sales outlook remains modest but could accelerate with expanded indications and geographic access.
• Pricing strategies are aligned with class standards; reimbursement remains a key factor.
• Pipeline and trial progress can influence the long-term value proposition.

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FAQs

1. How does TAVALISSE compare to other BTK inhibitors in clinical outcomes?
TAVALISSE shows similar response rates to ibrutinib but has fewer cardiovascular adverse effects, which may influence treatment choices for specific patient populations.

2. What are the main barriers to wider market adoption?
Market penetration faces challenges from established competitors, limited regulatory approval outside the US, and payer reimbursement hurdles.

3. Is TAVALISSE expected to expand into other indications?
Ongoing trials aim to evaluate efficacy in other B-cell malignancies, which could broaden its use and sales.

4. How does pricing influence its adoption?
Pricing at approximately $10,000 per month positions TAVALISSE as a premium drug; reimbursement constraints could limit access unless clinical benefits justify the cost.

5. What is the long-term sales potential?
If clinical and regulatory milestones are met and market access expands, sales could increase substantially, with projections suggesting growth beyond $100 million annually within five years.

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References

[1] Clinical trial registry NCT03981373.
[2] FDA label for TAVALISSE.
[3] IQVIA reports.
[4] Rigel Pharmaceuticals. HEATwave interim data.
[5] CMS and payer guidelines, 2023.