Ivosidenib - Generic Drug Details

What are the generic sources for ivosidenib and what is the scope of freedom to operate?

Ivosidenib is the generic ingredient in one branded drug marketed by Servier and is included in one NDA. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ivosidenib has one hundred and sixty-six patent family members in forty-four countries.

One supplier is listed for this compound.

Summary for ivosidenib

International Patents:	166
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	28
Patent Applications:	322
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ivosidenib
What excipients (inactive ingredients) are in ivosidenib?	ivosidenib excipients list
DailyMed Link:	ivosidenib at DailyMed

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

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 ivosidenib

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

Sponsor	Phase
Servier Bio-Innovation LLC	Phase 3
Servier Bio-Innovation LLC	Phase 1/Phase 2
Institut de Recherches Internationales Servier	Phase 1/Phase 2

See all ivosidenib clinical trials

Pharmacology for ivosidenib

Drug Class	Isocitrate Dehydrogenase 1 Inhibitor
Mechanism of Action	Cytochrome P450 2C9 Inducers Cytochrome P450 3A4 Inducers Isocitrate Dehydrogenase 1 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ivosidenib

L01XM	Isocitrate dehydrogenase (IDH) inhibitors
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

L01XX	Other antineoplastic agents
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for IVOSIDENIB

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TIBSOVO	Tablets	ivosidenib	250 mg	211192	1	2022-07-20

US Patents and Regulatory Information for ivosidenib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Servier	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes
Servier	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes
Servier	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes
Servier	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes
Servier	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes			Y	Y
Servier	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes

EU/EMA Drug Approvals for ivosidenib

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Les Laboratoires Servier	Tibsovo	ivosidenib	EMEA/H/C/005936 Tibsovo in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive standard induction chemotherapy (see section 5.1).Tibsovo monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy.	Authorised	no	no	yes	2023-05-04

International Patents for ivosidenib

Country	Patent Number	Title	Estimated Expiration
Japan	6067226
World Intellectual Property Organization (WIPO)	2015138839
Israel	258685	טיפול משולב לממאירות (Combination therapy for treating malignancies)
Mexico	2016011810	COMPOSICIONES FARMACEUTICAS DE COMPUESTOS TERAPEUTICAMENTE ACTIVOS Y SUS METODOS DE USO. (PHARMACEUTICAL COMPOSITIONS OF THERAPEUTICALLY ACTIVE COMPOUNDS.)
Taiwan	201843136	Therapeutically active compositions and their methods of use
Lithuania	3447052

Supplementary Protection Certificates for ivosidenib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2804851	C202330033	Spain		PRODUCT NAME: IVOSIDENIB O UNA SAL, TAUTOMERO, ISOTOPOLOGO O HIDRATO FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/23/1728; DATE OF AUTHORISATION: 20230504; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/23/1728; DATE OF FIRST AUTHORISATION IN EEA: 20230504
2804851	LUC00315	Luxembourg		PRODUCT NAME: IVOSIDENIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, TAUTOMER, ISOTOPOLOGUE OR HYDRATE THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/23/1728 20230508
2804851	30/2023	Austria		PRODUCT NAME: IVOSIDENIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ, TAUTOMER, ISOTOPOLOG ODER HYDRAT DAVON; REGISTRATION NO/DATE: EU/1/23/1728 (MITTEILUNG) 20230508
2804851	301243	Netherlands		PRODUCT NAME: IVOSIDENIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT, TAUTOMEER, ISOTOPOLOOG OF HYDRAAT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1728 20230508
2804851	C02804851/01	Switzerland		PRODUCT NAME: IVOSIDENIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 69077 13.06.2024
2804851	2023C/534	Belgium		PRODUCT NAME: IVOSIDENIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT, TAUTOMEER, ISOTOPOLOOG OF HYDRAAT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1728 20230508

Market Dynamics and Financial Trajectory for Ivosidenib

Market Overview

The ivosidenib market is poised for significant growth, driven by its efficacy in treating specific types of cancer, particularly those with IDH1 mutations. As of 2024, the global ivosidenib market size was estimated at USD 18.5 million, with a projected compound annual growth rate (CAGR) of 4.20% from 2024 to 2031[1].

Regional Market Breakdown

North America

North America dominates the ivosidenib market, accounting for more than 40% of the global revenue, with a market size of USD 7.4 million in 2024. This region is expected to grow at a CAGR of 2.4% from 2024 to 2031. The growth is attributed to the focus on precision medicine and better treatment options for Acute Myeloid Leukemia (AML), especially in cases with FLT3 mutations[1].

Europe

Europe holds a significant share of the ivosidenib market, driven by strong oncology research and development, increasing cancer prevalence, and government initiatives for cancer treatment. The European market benefits from EMA approvals, ensuring standardized access to ivosidenib across multiple countries[4].

Asia Pacific

The Asia Pacific region is expected to be the fastest-growing segment, with a CAGR of 6.2% from 2024 to 2031. This growth is fueled by increasing cancer awareness, expanding healthcare infrastructure, and a rising demand for advanced treatments in emerging economies like China and India[1].

South America and Middle East & Africa

South America and the Middle East & Africa also show promising growth, with CAGRs of 3.6% and 3.9%, respectively, from 2024 to 2031. These regions are seeing increased recognition of ivosidenib's importance in treating FLT3-mutated AML, leading to higher demand and implementation of this targeted therapy[1].

Drivers of Market Growth

Increasing Prevalence of IDH1-Mutated Cancers

The growing prevalence of diseases like AML and cholangiocarcinoma with IDH1 mutations is a key driver of the ivosidenib market. These mutations are present in a significant percentage of AML cases, making ivosidenib a critical treatment option[4].

Advancements in Precision Medicine

The advancement of precision medicine and genetic testing is increasing the demand for targeted therapies like ivosidenib. This drug selectively blocks IDH1 gene alterations, restoring normal cell differentiation and slowing or stopping cancer progression[4].

Regulatory Approvals

Regulatory approvals from organizations such as the FDA and EMA are crucial for the market growth of ivosidenib. For instance, the FDA has granted priority review to the supplemental new drug application for ivosidenib in treating IDH1-mutated, relapsed/refractory myelodysplastic syndrome (MDS)[2].

Reimbursement Practices

Good reimbursement practices in strategic areas improve the uptake and accessibility of ivosidenib, further fueling its market growth[4].

Clinical Efficacy and Safety

Efficacy Data

Ivosidenib has demonstrated significant efficacy in clinical trials. For example, in newly diagnosed AML patients ineligible for standard treatment, ivosidenib showed a combined complete remission (CR) and CR with partial hematologic recovery (CRh) rate of 42.4% and an overall response rate (ORR) of 57.6%[5].

Safety Profile

The safety profile of ivosidenib is consistent with previously reported data. Common adverse events include diarrhea, fatigue, nausea, and decreased appetite. Serious adverse events are manageable, and the drug does not typically lead to permanent treatment discontinuations[5].

Market Forecast

The ivosidenib market is projected to continue its upward trend. By 2031, the market is expected to expand significantly, driven by the increasing demand for targeted cancer therapies and the growing awareness of ivosidenib's effectiveness in treating IDH1-mutated cancers[1][3].

Key Market Players

Agios Pharmaceuticals is a major player in the ivosidenib market, driving innovation and clinical development of this drug. Other pharmaceutical companies and research institutions also contribute to the robust R&D and market growth[4].

Financial Insights

Revenue and Growth Rate

As of 2024, the global ivosidenib market revenue was USD 18.5 million. The market is expected to grow at a CAGR of 4.20% from 2024 to 2031, indicating a steady financial trajectory[1].

Regional Revenue Contributions

North America, Europe, Asia Pacific, South America, and the Middle East & Africa contribute significantly to the global revenue. North America holds the largest share, followed by Europe and Asia Pacific[1].

Key Takeaways

• The global ivosidenib market is valued at USD 18.5 million as of 2024 and is expected to grow at a CAGR of 4.20% until 2031.
• North America dominates the market, driven by precision medicine and better treatment options for AML.
• Asia Pacific is the fastest-growing region due to increasing cancer awareness and expanding healthcare infrastructure.
• Regulatory approvals and good reimbursement practices are key drivers of market growth.
• Ivosidenib has shown significant clinical efficacy and a manageable safety profile.

FAQs

What is ivosidenib used for?

Ivosidenib is used for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation. It is also being considered for the treatment of IDH1-mutated, relapsed/refractory myelodysplastic syndrome (MDS)[2][5].

What is the current market size of ivosidenib?

As of 2024, the global ivosidenib market size is estimated at USD 18.5 million[1].

What is the projected growth rate of the ivosidenib market?

The ivosidenib market is expected to grow at a compound annual growth rate (CAGR) of 4.20% from 2024 to 2031[1].

Which region dominates the ivosidenib market?

North America dominates the ivosidenib market, accounting for more than 40% of the global revenue[1].

What are the common adverse events associated with ivosidenib?

Common adverse events include diarrhea, fatigue, nausea, and decreased appetite. Serious adverse events are manageable and do not typically lead to permanent treatment discontinuations[5].

Sources:

1. Cognitive Market Research - Global Ivosidenib Market Report
2. Onclive - FDA Grants Priority Review to Ivosidenib for IDH1+ Relapsed/Refractory MDS
3. Market Research Intellect - Ivosidenib Drugs Market Size and Forecast
4. We Market Research - Ivosidenib Market Size, Trends & Industry Analysis 2034
5. Agios Pharmaceuticals - Updated Data from the Ivosidenib Phase 1 Dose-Escalation and Expansion Trial

Last updated: 2024-12-16