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 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

Summary for TAVALISSE

International Patents:	118
US Patents:	14
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	194
Clinical Trials:	3
Patent Applications:	2,071
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

Hong Kong

Hungary

Japan

Lithuania

Mexico

Poland

Portugal

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
South Korea	102090440
Eurasian Patent Organization	028432	НОВЫЕ СОСТАВЫ НА ОСНОВЕ (ТРИМЕТОКСИФЕНИЛАМИНО)ПИРИМИДИНИЛОВ (NEW (TRIMETHOXYPHENYLAMINO)PYRIMIDINYL FORMULATIONS)
China	101115761	Prodrugs of 2,4-pyrimidinediamine compounds and their uses
South Korea	20190109576	신규한 피리미디닐 제형 (NEW TRIMETHOXYPHENYLAMINOPYRIMIDINYL FORMULATIONS)

Supplementary Protection Certificates for TAVALISSE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1856135	PA2020507	Lithuania		PRODUCT NAME: FOSTAMATINIBO DINATRIO HEKSAHIDRATAS; REGISTRATION NO/DATE: EU/1/19/1405 20200109
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	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	SPC/GB20/016	United Kingdom		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

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