Fostamatinib disodium - Generic Drug Details

What are the generic drug sources for fostamatinib disodium and what is the scope of freedom to operate?

Fostamatinib disodium is the generic ingredient in one branded drug marketed by Rigel Pharms and is included in one NDA. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fostamatinib disodium has one hundred and eighteen patent family members in forty-five countries.

One supplier is listed for this compound.

Summary for fostamatinib disodium

International Patents:	118
US Patents:	14
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	112
Clinical Trials:	19
Patent Applications:	518
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fostamatinib disodium
DailyMed Link:	fostamatinib disodium at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for fostamatinib disodium

Constraining patent/regulatory exclusivity:

8,771,648

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 fostamatinib disodium

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Rigel Pharmaceuticals	Phase 3
AstraZeneca	Phase 2
AstraZeneca	Phase 3

See all fostamatinib disodium clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for fostamatinib disodium

B02BX	Other systemic hemostatics
B02B	VITAMIN K AND OTHER HEMOSTATICS
B02	ANTIHEMORRHAGICS
B	Blood and blood forming organs

Paragraph IV (Patent) Challenges for FOSTAMATINIB DISODIUM

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 fostamatinib disodium

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	209299-001	Apr 17, 2018		RX	Yes	No	8,163,902			Y
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-001	Apr 17, 2018		RX	Yes	No	8,652,492		Y
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-001	Apr 17, 2018		RX	Yes	No	7,538,108			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	209299-002	Apr 17, 2018		RX	Yes	Yes	7,989,448			Y
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-001	Apr 17, 2018		RX	Yes	No	8,912,170

International Patents for fostamatinib disodium

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)
Norway	20074179
Slovenia	2217241

Supplementary Protection Certificates for fostamatinib disodium

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
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	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

Market Dynamics and Financial Trajectory for Fostamatinib Disodium

Introduction

Fostamatinib disodium, marketed as TAVALISSE, is a significant player in the treatment of autoimmune disorders, particularly chronic immune thrombocytopenia (ITP) and other conditions. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Drivers

The fostamatinib disodium market is driven by several key factors:

Increasing Prevalence of Autoimmune Disorders

The rising prevalence of chronic immune thrombocytopenia (ITP) and other autoimmune disorders globally is a primary driver. As lifestyle factors, environmental influences, and genetic predispositions contribute to the increase in these conditions, the demand for effective treatments like fostamatinib is escalating[3].

Clinical Evidence and Efficacy

The growing body of clinical evidence supporting the efficacy and safety of fostamatinib is crucial. Positive results from Phase II and III trials, such as the TASKi trials, have shown significant improvements in patient outcomes, boosting confidence among healthcare providers[1].

Healthcare Expenditure and Access

Increasing healthcare expenditure in both developed and emerging markets is facilitating greater access to novel therapies. Expanding reimbursement policies for innovative drugs like fostamatinib are likely to increase its adoption, particularly in emerging economies[3].

Market Opportunities

Several opportunities are on the horizon for fostamatinib disodium:

Expansion of Indications

Ongoing clinical trials are exploring the drug's efficacy in treating other autoimmune disorders such as warm antibody autoimmune hemolytic anemia (wAIHA), IgA nephropathy, and COVID-19-related complications. Positive outcomes could substantially broaden the patient population and drive significant market growth[3].

Geographical Expansion

While fostamatinib has gained approval and market presence in regions like the United States and Europe, there is significant potential for growth in emerging markets. Strategic partnerships with local pharmaceutical companies and healthcare providers could facilitate this expansion[3].

COVID-19 Related Opportunities

Research into fostamatinib's potential role in treating COVID-19-related complications has opened up new market opportunities. If further research supports these initial findings and leads to regulatory approvals, it could open up an entirely new market segment[3].

Market Restraints

Despite the opportunities, there are several challenges that could impact the market trajectory:

Pricing Pressures and Regulatory Challenges

High acquisition costs and the need for significant price reductions to achieve favorable cost-effectiveness ratios can be a barrier. For instance, a 60.2% price reduction is needed to achieve an ICER of $50,000 per QALY in certain reimbursement populations[4].

Competition from Existing and Emerging Therapies

The market for autoimmune disorder treatments is competitive, with both existing and emerging therapies posing a challenge. Fostamatinib must compete with other treatments that may offer similar or better efficacy and safety profiles[3].

Financial Performance

Rigel Pharmaceuticals, the developer of fostamatinib disodium, has seen significant financial activity related to the drug:

Revenue Growth

In the third quarter of 2024, TAVALISSE net product sales grew 8% compared to the same period in 2023, reaching $26.3 million. For the nine months ended September 30, 2024, TAVALISSE net product sales were $73.8 million, indicating steady growth[2].

Contract Revenues

Contract revenues from collaborations, including those with Kissei Pharmaceutical Co., Ltd., Grifols S.A., and Medison Pharma Trading AG, contributed significantly to Rigel's total revenues. These collaborations included upfront fees, delivery of drug supplies, and earned royalties[2].

Costs and Expenses

Total costs and expenses for Rigel increased due to higher costs of product sales, personnel-related costs, and commercial-related expenses. However, research and development costs decreased due to the completion of certain clinical trials and the timing of activities related to other programs[2].

Clinical Trials and Development

Fostamatinib disodium has undergone extensive clinical trials:

Phase II and III Trials

The drug completed a comprehensive Phase II program, including the TASKi trials, which showed promising results in patients with inadequate response to methotrexate and biologic therapies. A global Phase III program was initiated in 2010, with the goal of filing new drug applications with regulatory agencies[1].

Current and Future Trials

Rigel has been involved in Phase 3 clinical trials for fostamatinib in patients with COVID-19 and warm antibody hemolytic anemia (wAIHA). These trials have contributed to the financial performance and market positioning of the drug[2][5].

Strategic Collaborations

The collaboration between AstraZeneca and Rigel Pharmaceuticals has been pivotal in the development and commercialization of fostamatinib disodium. This partnership ensured a substantial clinical program and provided Rigel with royalties on potential future sales, aligning with their investment in the drug's development[1].

Key Takeaways

• Fostamatinib disodium is driven by increasing prevalence of autoimmune disorders and growing clinical evidence.
• The drug has significant market opportunities in expanding indications, geographical expansion, and treating COVID-19-related complications.
• Pricing pressures, regulatory challenges, and competition are key restraints.
• Rigel Pharmaceuticals has seen revenue growth from TAVALISSE sales and contract revenues.
• Ongoing and completed clinical trials have been crucial in shaping the drug's market trajectory.

FAQs

Q: What is fostamatinib disodium used for? A: Fostamatinib disodium, marketed as TAVALISSE, is primarily used for the treatment of chronic immune thrombocytopenia (ITP) and is being explored for other autoimmune disorders.

Q: Who are the key players involved in the development and commercialization of fostamatinib disodium? A: The key players include Rigel Pharmaceuticals and AstraZeneca, which have a worldwide license agreement for the drug.

Q: What are the main drivers of the fostamatinib disodium market? A: The main drivers include the increasing prevalence of autoimmune disorders, growing clinical evidence, and increasing healthcare expenditure.

Q: What are the potential new indications for fostamatinib disodium? A: Ongoing clinical trials are exploring its efficacy in treating warm antibody autoimmune hemolytic anemia (wAIHA), IgA nephropathy, and COVID-19-related complications.

Q: How has the COVID-19 pandemic impacted the fostamatinib disodium market? A: The pandemic has highlighted the importance of managing chronic conditions effectively and has sparked interest in fostamatinib's potential role in treating COVID-19-related complications, opening up new market opportunities.

Sources:

1. AstraZeneca and Rigel Pharmaceuticals Sign Worldwide License Agreement for Fostamatinib Disodium - AstraZeneca Media Centre.
2. Rigel Reports Third Quarter 2024 Financial Results and Provides Business Update - Rigel Pharmaceuticals.
3. Fostamatinib Tablets Market Size, Growth and Analysis Report - 2033 - DataHorizzon Research.
4. Pharmacoeconomic Review - Fostamatinib (Tavalisse) - NCBI.
5. Rigel Reports Second Quarter 2023 Financial Results and Provides Business Update - PR Newswire.

Last updated: 2024-12-17