TAVALISSE Drug Patent Profile

Which patents cover Tavalisse, 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

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 and one FDA Regulatory Exclusivity.

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	RE48898		Y
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	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
Russian Federation	2007131430	ПРОЛЕКАРСТВА СОЕДИНЕНИЙ 2,4-ПИРИМИДИНДИАМИНА И ИХ ПРИМЕНЕНИЕ
Norway	2020010
Finland	C20200014
World Intellectual Property Organization (WIPO)	2008064274

Supplementary Protection Certificates for TAVALISSE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
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

Market Dynamics and Financial Trajectory for TAVALISSE (Fostamatinib) in the Pharmaceutical Landscape

Last updated: July 27, 2025

Introduction

TAVALISSE (fostamatinib) represents a targeted kinase inhibitor developed by Rigel Pharmaceuticals, approved by the U.S. Food and Drug Administration (FDA) for the treatment of chronic immune thrombocytopenia (ITP) in adults. As a novel therapeutic in the hematology space, TAVALISSE’s market landscape is shaped by shifting clinical needs, competitive forces, regulatory pathways, and evolving payer strategies. This analysis offers a comprehensive overview of the drug's market dynamics and its projected financial trajectory, providing essential insights for stakeholders in pharmaceutical R&D, investment, and commercialization.

Product Overview and Therapeutic Positioning

Fostamatinib functions as a spleen tyrosine kinase (SYK) inhibitor, targeting pathways critical in platelet destruction mechanisms. Its approval for ITP—a rare autoimmune disorder—positions it within a niche but high-need market segment. Currently, TAVALISSE signifies the first oral SYK inhibitor approved for chronic ITP, distinguishing it from first-line therapies like corticosteroids or splenectomy, and second-line treatments such as thrombopoietin receptor agonists (TPO-RAs) (e.g., eltrombopag, romiplostim).

The drug’s unique mechanism offers potential advantages, including efficacy in patients refractory to existing therapies and an oral administration route, which aligns with patient preference trends. However, safety concerns and competition from newer biologics and small molecules influence its adoption trajectory.

Market Dynamics Influencing TAVALISSE

1. Therapeutic Need and Patient Demographics

Chronic ITP affects approximately 3-4 per 100,000 adults annually, predominantly impacting populations aged 50 and above. The unmet clinical need for effective, oral, and well-tolerated options sustains demand for TAVALISSE, particularly in refractory cases. Nevertheless, the limited patient population constrains its market size, emphasizing the importance of niche targeting and precise patient stratification.

2. Competitive Landscape

The ITP treatment market comprises established therapies—TPO-RAs (romiplostim, eltrombopag), corticosteroids, immunosuppressants, and splenectomy. While TAVALISSE’s oral route offers convenience, its safety profile, including risks of hypertension and hepatotoxicity, may restrict its widespread adoption.

Innovations such as next-generation biologics and biosimilars targeting ITP are emerging, potentially threatening TAVALISSE’s market share. For example, therapies like avatrombopag and newer agents with improved efficacy or safety could challenge fostamatinib’s positioning.

3. Regulatory and Reimbursement Environment

Favorable regulatory status, including FDA approval for specific indications, facilitates market access. However, pricing strategies, reimbursement policies, and value-based care models influence prescription patterns.

Reimbursement hurdles may limit TAVALISSE’s penetration, especially if payers favor established therapies with long-term safety data or negotiate discounts based on comparative effectiveness.

4. Clinical Evidence and Real-World Data

Post-marketing surveillance and real-world data will determine TAVALISSE’s long-term safety and efficacy perceptions. Positive data support market growth, while emerging safety signals could impede uptake.

5. Adoption Barriers and Physician Preferences

Physician familiarity with existing treatments, comfort with new mechanisms, and experience with managing side effects critically impact adoption rates. Education and evidence dissemination are vital for expanding TAVALISSE’s share in the treatment algorithm.

Financial Trajectory and Market Projections

1. Revenue Potential

Given its niche positioning, TAVALISSE’s peak sales are projected to remain modest relative to blockbuster drugs. Industry estimates suggest global peak sales could range from $200 million to $500 million within 5-7 years post-approval, primarily driven by markets in North America and select European regions.

The drug’s revenue outlook depends on factors such as:

• Market penetration rate among refractory ITP patients.
• Pricing strategies aligned with comparator therapies.
• Clinical expansion into other autoimmune hematologic disorders, if clinical trials demonstrate broader efficacy.

2. Growth Drivers

Key elements fueling growth include:

• Expansion of approved indications: Future approvals for other autoimmune or hematologic conditions could diversify revenue streams.
• Combination therapy adoption: Incorporation of TAVALISSE into combination regimens might enhance efficacy and extend its utility.
• Increased awareness and physician education: Facilitating quicker adoption in specialized centers.

3. Challenges Limiting Revenue Growth

Factors hindering scalability include:

• Market competition from biosimilars and novel agents.
• Safety concerns and tolerability issues affecting long-term use.
• Limited patient population constraining overall sales potential.

4. Investment and R&D Outlook

Rigel Pharmaceuticals and partner companies are exploring next-gen formulations, expanded indications, and biomarker-driven patient selection. These efforts could influence the drug’s financial trajectory by enhancing efficacy, safety, or market reach.

Market Trends and Future Outlook

Emerging Trends

• Personalized medicine approaches optimize patient selection for TAVALISSE.
• Real-world evidence collection influences reimbursement and clinical guidelines.
• Strategic collaborations and licensing agreements expand access and distribution.

Long-term Projections

The sales forecast for TAVALISSE remains cautiously optimistic, emphasizing the importance of clinical evidence and market positioning. As the hematology landscape evolves with innovative therapies and precision medicine strategies, TAVALISSE’s market share and revenue potential will adjust correspondingly.

Regulatory and Commercial Strategies

To maximize its financial trajectory, Rigel Pharmaceuticals should focus on:

• Expanding clinical indications through robust Phase II/III trials.
• Engaging payers and healthcare providers through value-based propositions.
• Building clinician awareness via targeted education campaigns.
• Investing in pharmacovigilance to bolster safety profile credibility.

Key Takeaways

• TAVALISSE holds niche market potential driven by its novel mechanism and oral administration for refractory ITP patients.
• Competitive pressures and safety profiles are critical factors influencing market adoption.
• Estimated peak global sales likely hover between $200 million and $500 million.
• Expanding indications and personalized medicine approaches could enhance revenue streams.
• Strategic collaborations and evidence generation are essential to sustain growth and market presence.

FAQs

1. What are the primary market opportunities for TAVALISSE?
TAVALISSE’s main opportunity lies in treating adult patients with chronic ITP refractory to standard therapies, especially where oral administration and novel mechanisms are desired.

2. How does TAVALISSE compare to other ITP treatments in terms of safety and efficacy?
While effective in reducing bleeding episodes, TAVALISSE’s safety profile includes hypertension and hepatotoxicity concerns. Its efficacy in refractory ITP complements, rather than replaces, existing therapies like TPO-RAs.

3. What factors could limit TAVALISSE’s market growth?
Market limitations encompass safety concerns, competition from newer agents, narrow patient eligibility, and payer reimbursement challenges.

4. Are there prospects for expanding TAVALISSE’s indications?
Potential exists if clinical trials demonstrate efficacy in other autoimmune or hematologic conditions, which could broaden its applicability and revenues.

5. What strategies should pharmaceutical companies employ to maximize TAVALISSE’s market potential?
Focus on evidence generation, healthcare professional education, strategic partnerships, and pursuing additional indications to enhance market penetration and financial returns.

References

1. FDA Approval Announcement, Rigel Pharmaceuticals.
2. Market Research Reports on Hematology Drugs, 2022-2023.
3. Clinical Trial Data, Independent Hematology Journals.
4. "Fostamatinib (TAVALISSE) in ITP," National Comprehensive Cancer Network Guidelines, 2022.
5. Industry analyses on kinase inhibitors and autoimmune disease therapeutics.