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Last Updated: June 20, 2025

TAVALISSE Drug Patent Profile


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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 eighteen patent family members in forty-five 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

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Drug patent expirations by year for TAVALISSE
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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TAVALISSE
Generic Entry Date for TAVALISSE*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Holdsworth House Medical PracticePhase 2
Washington University School of MedicinePhase 2
Rigel PharmaceuticalsPhase 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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TAVALISSE is ⤷  Try for Free.

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 ⤷  Try for Free Y ⤷  Try for Free
Rigel Pharms TAVALISSE fostamatinib disodium TABLET;ORAL 209299-002 Apr 17, 2018 RX Yes Yes 8,771,648 ⤷  Try for Free Y ⤷  Try for Free
Rigel Pharms TAVALISSE fostamatinib disodium TABLET;ORAL 209299-001 Apr 17, 2018 RX Yes No 9,283,238 ⤷  Try for Free ⤷  Try for Free
Rigel Pharms TAVALISSE fostamatinib disodium TABLET;ORAL 209299-002 Apr 17, 2018 RX Yes Yes 9,283,238 ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Patent: 7371
Patent: FORMULACIONES DE (TRIMETOXIFENILAMINO)PIRIMIDINILO, METODOS
Estimated Expiration: ⤷  Try for Free

Australia

Patent: 12288632
Patent: New (trimethoxyphenylamino)pyrimidinyl formulations
Estimated Expiration: ⤷  Try for Free

Brazil

Patent: 2014001999
Patent: composição farmacêutica, forma de dosagem unitária, formulação de granulação a úmido, formulação de compactação por roletes, formulação de compressão direta, e, método para a preparação de uma composição farmacêutica
Estimated Expiration: ⤷  Try for Free

Canada

Patent: 43138
Patent: NOUVELLES FORMULATIONS DE (TRIMETHOXYPHENYLAMINO)PYRIMIDINYLE (NEW (TRIMETHOXYPHENYLAMINO)PYRIMIDINYL FORMULATIONS)
Estimated Expiration: ⤷  Try for Free

China

Patent: 3826610
Patent: New (trimethoxyphenylamino)pyrimidinyl formulations
Estimated Expiration: ⤷  Try for Free

Croatia

Patent: 0190186
Estimated Expiration: ⤷  Try for Free

Cyprus

Patent: 22596
Estimated Expiration: ⤷  Try for Free

Denmark

Patent: 36487
Estimated Expiration: ⤷  Try for Free

Eurasian Patent Organization

Patent: 8432
Patent: НОВЫЕ СОСТАВЫ НА ОСНОВЕ (ТРИМЕТОКСИФЕНИЛАМИНО)ПИРИМИДИНИЛОВ (NEW (TRIMETHOXYPHENYLAMINO)PYRIMIDINYL FORMULATIONS)
Estimated Expiration: ⤷  Try for Free

Patent: 1490363
Patent: НОВЫЕ СОСТАВЫ НА ОСНОВЕ (ТРИМЕТОКСИФЕНИЛАМИНО)ПИРИМИДИНИЛОВ
Estimated Expiration: ⤷  Try for Free

European Patent Office

Patent: 36487
Patent: NOUVELLES FORMULATIONS DE (TRIMÉTHOXYPHÉNYLAMINO)PYRIMIDINYLE (NEW (TRIMETHOXYPHENYLAMINO)PYRIMIDINYL FORMULATIONS)
Estimated Expiration: ⤷  Try for Free

Hong Kong

Patent: 98741
Patent: 新的 三甲氧基苯氨基 嘧啶基配製品 (NEW (TRIMETHOXYPHENYLAMINO)PYRIMIDINYL FORMULATIONS ())
Estimated Expiration: ⤷  Try for Free

Hungary

Patent: 42611
Estimated Expiration: ⤷  Try for Free

Japan

Patent: 19116
Estimated Expiration: ⤷  Try for Free

Patent: 14521630
Estimated Expiration: ⤷  Try for Free

Lithuania

Patent: 36487
Estimated Expiration: ⤷  Try for Free

Mexico

Patent: 9685
Patent: FORMULACIONES DE (TRIMETOXIFENILAMINO) PIRIMIDINILO NUEVAS. (NEW (TRIMETHOXYPHENYLAMINO)PYRIMIDINYL FORMULATIONS.)
Estimated Expiration: ⤷  Try for Free

Patent: 14001065
Patent: FORMULACIONES DE (TRIMETOXIFENILAMINO) PIRIMIDILINO NUEVAS. (NEW (TRIMETHOXYPHENYLAMINO)PYRIMIDINYL FORMULATIONS.)
Estimated Expiration: ⤷  Try for Free

Poland

Patent: 36487
Estimated Expiration: ⤷  Try for Free

Portugal

Patent: 36487
Estimated Expiration: ⤷  Try for Free

Serbia

Patent: 433
Patent: NOVE FORMULACIJE (TRIMETOKSIFENILAMINO)PIRIMIDINILA (NEW (TRIMETHOXYPHENYLAMINO)PYRIMIDINYL FORMULATIONS)
Estimated Expiration: ⤷  Try for Free

Slovenia

Patent: 36487
Estimated Expiration: ⤷  Try for Free

South Korea

Patent: 2024120
Estimated Expiration: ⤷  Try for Free

Patent: 2090440
Estimated Expiration: ⤷  Try for Free

Patent: 140058576
Patent: NEW (TRIMETHOXYPHENYLAMINO)PYRIMIDINYL FORMULATIONS
Estimated Expiration: ⤷  Try for Free

Patent: 190109576
Patent: 신규한 피리미디닐 제형 (NEW TRIMETHOXYPHENYLAMINOPYRIMIDINYL FORMULATIONS)
Estimated Expiration: ⤷  Try for Free

Spain

Patent: 10423
Estimated Expiration: ⤷  Try for Free

Taiwan

Patent: 1311251
Patent: New (trimethoxyphenylamino) pyrimidinyl formulations
Estimated Expiration: ⤷  Try for Free

Turkey

Patent: 1901792
Estimated Expiration: ⤷  Try for Free

Uruguay

Patent: 223
Patent: FORMULACIONES DE (TRIMETOXIFENILAMINO)PIRIMIDINILO NUEVAS
Estimated Expiration: ⤷  Try for Free

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
South Korea 102090440 ⤷  Try for Free
Eurasian Patent Organization 028432 НОВЫЕ СОСТАВЫ НА ОСНОВЕ (ТРИМЕТОКСИФЕНИЛАМИНО)ПИРИМИДИНИЛОВ (NEW (TRIMETHOXYPHENYLAMINO)PYRIMIDINYL FORMULATIONS) ⤷  Try for Free
China 101115761 Prodrugs of 2,4-pyrimidinediamine compounds and their uses ⤷  Try for Free
South Korea 20190109576 신규한 피리미디닐 제형 (NEW TRIMETHOXYPHENYLAMINOPYRIMIDINYL FORMULATIONS) ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TAVALISSE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1856135 PA2020507 Lithuania ⤷  Try for Free PRODUCT NAME: FOSTAMATINIBO DINATRIO HEKSAHIDRATAS; REGISTRATION NO/DATE: EU/1/19/1405 20200109
1856135 2020/017 Ireland ⤷  Try for Free 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 122020000021 Germany ⤷  Try for Free 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 SPC/GB20/016 United Kingdom ⤷  Try for Free 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; REGISTERED: UK EU/1/19/1405 (NI) 20200113; UK PLGB 12930/0022 20200113; UK PLGB 12930/0023 20200113
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Market Dynamics and Financial Trajectory for TAVALISSE

Introduction

TAVALISSE, developed by Rigel Pharmaceuticals, is a significant player in the treatment of chronic immune thrombocytopenia (ITP) in adults who have had an insufficient response to previous treatments. Here, we delve into the market dynamics and financial trajectory of TAVALISSE, highlighting its performance, growth, and future prospects.

Product Overview

TAVALISSE (fostamatinib disodium hexahydrate) is a spleen tyrosine kinase (SYK) inhibitor designed to treat ITP, a condition characterized by low platelet counts. Its approval and subsequent market performance have been pivotal for Rigel Pharmaceuticals.

Market Performance

Quarterly Sales

In the fourth quarter of 2023, TAVALISSE net product sales reached $25.7 million, representing a 17% increase compared to $21.9 million in the same period of 2022. This growth trend continued into 2024, with TAVALISSE net product sales growing 8% in the third quarter of 2024 compared to the same period in 2023, reaching $26.3 million[2][4].

Annual Sales

For the full year 2023, TAVALISSE net product sales were $93.7 million, a 24% increase from $75.8 million in 2022. This significant growth underscores the increasing adoption and acceptance of TAVALISSE in the medical community[1][4].

Bottles Shipped

The number of TAVALISSE bottles shipped to patients and clinics has also seen a notable increase. In the fourth quarter of 2023, a total of 2,671 bottles were sold, with 2,463 shipped directly to patients and clinics, marking the highest number of bottles shipped in a quarter since the drug's launch[1][4].

Revenue Growth

Quarterly Revenue

TAVALISSE has consistently shown strong quarterly revenue growth. For example, in the second quarter of 2023, TAVALISSE net product sales were $21.3 million, a 15% increase from $18.6 million in the same period of 2022. This trend continued in the second quarter of 2024, with a 24% growth compared to the same period in 2023, reaching $26.4 million[3][5].

Annual Revenue

The annual revenue from TAVALISSE has been steadily increasing. From $75.8 million in 2022 to $93.7 million in 2023, the drug has demonstrated robust market performance and acceptance[1][4].

Market Dynamics

Physician Awareness and Adoption

Increased physician awareness and adoption have been key drivers of TAVALISSE's success. Rigel Pharmaceuticals' efforts to educate healthcare providers about the benefits of TAVALISSE have led to higher prescription rates and patient usage[1][4].

Competitive Landscape

In the ITP treatment market, TAVALISSE faces competition from other therapies, but its unique mechanism of action as a SYK inhibitor sets it apart. The drug's efficacy and safety profile have helped it gain a significant market share[1].

Patient Access

Rigel's focus on ensuring patient access through direct shipping and other support programs has contributed to the drug's success. The company has reported the highest number of bottles shipped directly to patients and clinics in several quarters, indicating strong patient demand[1][4].

Financial Trajectory

Total Revenues

Rigel Pharmaceuticals' total revenues, largely driven by TAVALISSE, have shown significant growth. For the full year 2023, total revenues were $116.9 million, with TAVALISSE contributing $93.7 million. In the first nine months of 2024, total revenues were $121.7 million, with TAVALISSE net product sales at $73.8 million[1][2].

Contract Revenue

In addition to product sales, Rigel generates revenue from collaborations. Contract revenue from partnerships with companies like Grifols, Kissei, and Medison has contributed to the overall financial health of the company. For example, in the third quarter of 2024, contract revenue from collaborations was $16.4 million[2].

Future Prospects

Commercial Expansion

Rigel is focused on commercial expansion and execution in 2024. The company aims to further increase the market penetration of TAVALISSE and its other products, including REZLIDHIA and the newly acquired GAVRETO[1][2].

Pipeline Advancement

Rigel is also advancing its pipeline through strategic collaborations, such as those with MD Anderson and CONNECT, to evaluate the potential of REZLIDHIA in various cancers. These initiatives could lead to additional revenue streams and further solidify the company's position in the hematology-oncology market[4].

Financial Breakeven

Rigel's goal to reach financial breakeven is supported by the strong performance of TAVALISSE and the growing revenue from its other products. The company's financial trajectory suggests that it is on track to achieve this goal in the near future[4].

Key Takeaways

  • Strong Sales Growth: TAVALISSE has shown consistent growth in both quarterly and annual sales.
  • Increased Physician Adoption: Higher physician awareness and adoption have driven the drug's success.
  • Competitive Advantage: TAVALISSE's unique mechanism of action sets it apart in the ITP treatment market.
  • Patient Access: Direct shipping and support programs have enhanced patient access.
  • Financial Health: Rigel's total revenues, driven by TAVALISSE, have seen significant growth.
  • Future Expansion: The company is focused on commercial expansion and advancing its pipeline.

FAQs

What is TAVALISSE used for?

TAVALISSE is used for the treatment of adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

How has TAVALISSE performed in terms of sales?

TAVALISSE net product sales have shown significant growth, with a 17% increase in the fourth quarter of 2023 compared to the same period in 2022, and an 8% growth in the third quarter of 2024.

What factors have contributed to the success of TAVALISSE?

Increased physician awareness and adoption, along with Rigel's efforts to ensure patient access, have been key drivers of TAVALISSE's success.

How does TAVALISSE fit into Rigel's overall financial trajectory?

TAVALISSE is a major contributor to Rigel's total revenues, which have seen significant growth. The drug's performance is crucial to the company's goal of reaching financial breakeven.

What are Rigel's future plans for TAVALISSE and its other products?

Rigel is focused on commercial expansion and execution, as well as advancing its pipeline through strategic collaborations to evaluate the potential of its products in various cancers.

How does TAVALISSE compare to other treatments for ITP?

TAVALISSE's unique mechanism of action as a spleen tyrosine kinase (SYK) inhibitor sets it apart in the ITP treatment market, offering a distinct therapeutic option for patients.

Sources

  1. Rigel Pharmaceuticals, Inc. - Rigel Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update.
  2. BioSpace - Rigel Reports Third Quarter 2024 Financial Results and Provides Business Update.
  3. Rigel Pharmaceuticals, Inc. - Rigel Reports Second Quarter 2023 Financial Results and Provides Business Update.
  4. Rigel Pharmaceuticals, Inc. - Rigel Pharmaceuticals Provides Business Update.
  5. Rigel Pharmaceuticals, Inc. - Rigel Reports Second Quarter 2024 Financial Results and Provides Business Update.
Last updated: 2024-12-16

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