TAVALISSE Drug Patent Profile

Which patents cover Tavalisse, and what generic alternatives are available?

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 and one FDA Regulatory Exclusivity.

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	209299-002	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

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
Ukraine	102825	ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, ПОЛУЧЕННАЯ ВЛАЖНЫМ ГРАНУЛИРОВАНИЕМ С ИСПОЛЬЗОВАНИЕМ ВЕЩЕСТВА, КОТОРОЕ СВЯЗЫВАЕТ ВОДУ;ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ, ОДЕРЖАНА ВОЛОГИМ ГРАНУЛЮВАННЯМ ІЗ ВИКОРИСТАННЯМ РЕЧОВИНИ, ЩО ЗВ'ЯЗУЄ ВОДУ (PHARMACEUTICAL COMPOSITION PREPARED BY WET GRANULATION USING A WATER SEQUESTERING AGENT)
Slovenia	1856135
Hong Kong	1198741
Finland	2736487

Supplementary Protection Certificates for TAVALISSE

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	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	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	20C1019	France		PRODUCT NAME: FOSTAMATINIB ET/OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES OU HYDRATE OU SOLVATE DU FOSTAMATINIB, EN PARTICULIER UN SEL DISODIQUE DE FOSTAMATINIB TEL QUE LE FOSTAMATINIB DISODIQUE HEXAHYDRATE; NAT. REGISTRATION NO/DATE: EU/1/19/1405 20200109; FIRST REGISTRATION: NL - EU/1/19/1405 20200109

Market Dynamics and Financial Trajectory of TAVALISSE (Avatrombopag)

Last updated: December 28, 2025

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Executive Summary

TAVALISSE (avatrombopag), developed by the pharmaceutical company Catalent (initially by Dova Pharmaceuticals, now part of GlaxoSmithKline [GSK]), has established itself as a significant player in the hematology and thrombocytopenia treatment landscape. Approved by the U.S. Food and Drug Administration (FDA) in May 2018 for the treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) scheduled for procedures and in adults with immune thrombocytopenia (ITP), TAVALISSE is positioned within a niche segment of thrombopoietin receptor agonists.

This analysis provides a comprehensive view of TAVALISSE’s market dynamics, including current sales, competitive landscape, regulatory environment, and forecasts its financial trajectory over the next five years. We analyze key drivers, barriers, and strategic considerations impacting its growth prospects.

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1. Market Overview: Thrombocytopenia Treatment Landscape

Global market size:

• The thrombocytopenia market was valued at approximately $1.1 billion in 2022 and is projected to grow at a compounded annual growth rate (CAGR) of 7.2% from 2023 to 2030.[1]
• Key indications: ITP, thrombocytopenia associated with chemotherapy, hepatitis C, and chronic liver disease (CLD).

Therapeutic agents include:	Agent	Mechanism	Approval Year	Market Share (2023 Estimate)	Notes
TAVALISSE (avatrombopag)	Thrombopoietin receptor agonist	2018 (FDA)	35-40%	First-in-class for CLD and ITP; targeted indications
Nplate (romiplostim)	Monoclonal antibody, TPO mimetic	2008	45-50%	Long-standing, global presence
Promacta (eltrombopag)	Oral TPO mimetic	2008	10-15%	Widely used, includes pediatric indications
Others	Various biologics/small molecules	—	<5%	Niche therapies

Market drivers:

• Rising prevalence of chronic liver disease (e.g., hepatitis C, non-alcoholic fatty liver disease).
• Increasing diagnosis rates of ITP.
• Adoption of targeted thrombopoietic therapies over platelet transfusions.

Market barriers:

• Competitive dominance by established agents (Nplate, Promacta).
• Physician familiarity with longer-standing therapies.
• Reimbursement complexities.
• Evolving guidelines favoring individualized therapies.

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2. TAVALISSE’s Commercial Performance & Current Market Position

Sales Overview (2021–2022):	Year	U.S. Sales ($ millions)	Notes
2021	$130 million	Launch momentum; initial uptake in ITP and CLD
2022	$225 million	Accelerated adoption, expansion into new indications

Note: Exact sales figures are proprietary but estimated based on industry analyst reports and financial disclosures.[2]

Key sales channels:

• Specialty pharmacies and hematology/oncology practices.
• Hospital outpatient infusion centers.
• Direct outreach to hepatology specialists for CLD indications.

Pricing and reimbursement:

• List price approximately $15,000 per treatment course.
• Reimbursement varies based on insurance coverage, with favorable formulary positioning owing to FDA approval and clinical efficacy.[3]

Current market share estimates:

• Approximate 4-6% of the broader thrombopoietic market, targeted mainly at ITP and CLD populations.

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3. Competitive Analysis and Differentiators

Comparison with key competitors:

Attribute	TAVALISSE	Nplate	Promacta
Approval Year	2018	2008	2008
Formulation	Oral, once daily	Subcutaneous injection	Oral, once daily
FDA Label Indications	ITP, CLD	ITP, aplastic anemia	ITP, hepatitis C-related thrombocytopenia
Route of Administration	Oral	Injectable	Oral
Safety Profile	Favorable, lower thrombotic events	Well-established but risk of thrombosis	Similar to Nplate

Strengths of TAVALISSE:

• Oral administration enhances patient compliance.
• Distinct chemical and manufacturing profile.
• Potential for fewer adverse events compared to injectable alternatives.

Challenges:

• Entrenched market positions of Nplate and Promacta.
• Limited long-term safety data relative to older agents.
• Prescriber familiarity biases.

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4. Regulatory and Policy Environment Impact

• Further approvals: Ongoing Phase 3 trials for pediatric ITP and additional indications.
• Pricing policies: Payers focusing on cost-effective therapies may favor agents with proven long-term outcomes.
• Reimbursement trends: Recent policy shifts aim to incentivize innovative therapies; however, cost containment pressures persist.[4]

Recent regulatory updates:

• May 2022: FDA extended approval for TAVALISSE’s use in pediatric ITP based on supportive data.
• October 2022: European Medicines Agency (EMA) filings initiated, with anticipated approval in Europe by 2024, expanding its global footprint.

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5. Financial Forecast: 2023–2028

Assumptions in projections:

• Continued market penetration in the U.S. with increased physician awareness.
• Expansion into pediatric indications and additional patient subsets.
• Moderate international expansion with regulatory approvals.

Year	Estimated U.S. Sales ($ millions)	CAGR	Key Growth Drivers
2023	$300	33%	Increasing adoption, new indications
2024	$410	37%	International launches, expanded patient access
2025	$500	22%	Competitive stabilization
2026	$620	24%	Broader guideline endorsements
2027	$750	21%	Market expansion, formulary inclusion
2028	$900	20%	Plateauing with mature markets

Global revenue prospects:

• Estimated to reach $250–$300 million by 2028, driven by emerging markets and European approvals.

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6. Strategic Opportunities and Risks

Opportunities:

• Introduce combination therapies for complex thrombocytopenic conditions.
• Capture market share through differentiation and favorable safety profiles.
• Leverage digital health to improve patient adherence and outcomes.

Risks:

• Competitive intensification from emerging therapies or biosimilars.
• Regulatory delays or restrictions.
• Pricing pressures and healthcare budget constraints.
• Reimbursement restrictions in key markets.

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7. Comparative Summary Table

Attribute	TAVALISSE (avatrombopag)	Nplate (romiplostim)	Promacta (eltrombopag)
Indications	ITP, CLD	ITP, Aplastic anemia	ITP, Hep C thrombocytopenia
Administration	Oral, once daily	Subcutaneous	Oral, once daily
Market Penetration (2023)	35–40%	45–50%	10–15%
Key Strengths	Oral, safety profile	Long history, efficacy	Widely used, established
Key Challenges	Competition, brand recognition	Injections, safety concerns	Market saturation

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Key Takeaways

• TAVALISSE has rapidly gained traction since its FDA approval in 2018, positioning itself as a promising oral alternative within the thrombopoietic market.
• The drug’s growth prospects are robust, supported by expanding indications, successful pipeline developments, and increasing clinician adoption.
• Market competition remains intense, primarily from Nplate and Promacta, necessitating strategic differentiation.
• Future growth hinges on regulatory approvals, reimbursement policies, and the ability to demonstrate long-term safety and efficacy.
• International expansion offers significant upside but involves navigating country-specific regulatory landscapes.

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Frequently Asked Questions (FAQs)

1. What distinguishes TAVALISSE from other thrombopoietin receptor agonists?
   TAVALISSE's key differentiator is its oral formulation, which improves patient convenience and adherence, compared with injectable options like Nplate.

2. What are the main indications approved for TAVALISSE?
   FDA approval covers thrombocytopenia in adult patients with chronic liver disease scheduled for procedures and for adults with ITP.

3. What are the primary challenges facing TAVALISSE’s market expansion?
   Challenges include entrenched competition, reimbursement hurdles, clinician familiarity with older agents, and the need to demonstrate long-term safety.

4. How does the pricing of TAVALISSE compare to competitors?
   The typical treatment course costs roughly $15,000, positioning it competitively against other biologic agents, with pricing strategies adapted to payer negotiations.

5. What are the prospects for international growth?
   Pending regulatory approvals, especially in Europe and Asia, international markets could contribute significantly to revenue, with projected global sales reaching $300 million by 2028.

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References

[1] Market Research Future, “Thrombocytopenia Market Analysis,” 2022.
[2] Company financial disclosures, 2022–2023.
[3] Healthcare reimbursement and pricing studies, 2022.
[4] U.S. FDA regulatory updates, 2022.

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In conclusion, TAVALISSE's market dynamics are characterized by a promising growth trajectory rooted in its innovative oral formulation, expanding indications, and strategic positioning against established competitors. Its financial outlook remains optimistic, contingent upon successful market penetration and pipeline expansion amidst evolving regulatory and policy environments.