Ivosidenib - Generic Drug Details

What are the generic sources for ivosidenib and what is the scope of patent protection?

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 seventy-six patent family members in forty-four countries.

One supplier is listed for this compound.

Summary for ivosidenib

International Patents:	176
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	39
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

Constraining patent/regulatory exclusivity:

9,968,595

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
Institute of Hematology & Blood Diseases Hospital, China	PHASE1
Servier Bio-Innovation LLC	PHASE1
Massachusetts General Hospital	PHASE2

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	9,850,277		Y	Y
Servier	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes	10,799,490		Y
Servier	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes	10,717,764
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

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/005936Tibsovo 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
Eurasian Patent Organization	035662	СПОСОБ ПОЛУЧЕНИЯ ТЕРАПЕВТИЧЕСКИ АКТИВНЫХ СОЕДИНЕНИЙ (PROCESS FOR PREPARING THERAPEUTICALLY ACTIVE COMPOUNDS)
Australia	2016338557
Mexico	2011009690	MÉTODOS Y COMPOSICIONES PARA TRASTORNOS RELACIONADOS CON LA PROLIFERACIÓN CELURAR. (METHODS AND COMPOSITIONS FOR CELL-PROLIFERATION-RELATED DISORDERS.)
Serbia	57730	DERIVATI LAKTAMA KORISNI KAO INHIBITORI MUTANTOG IDH1 (LACTAM DERIVATES USEFUL AS INHIBITORS OF MUTANT IDH1)
Australia	2019283951	THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE

Supplementary Protection Certificates for ivosidenib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2804851	C20230031	Finland		PRODUCT NAME: TSEDASURIDIIN/DETSITABIIN;REG NO/DATE: EU/1/23/1756 18.09.2023
2804851	PA2023529,C2804851	Lithuania		PRODUCT NAME: IVOSIDENIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA, TAUTOMERAS, IZOTOPOLOGAS ARBA HIDRATAS; REGISTRATION NO/DATE: EU/1/23/1728 20230504
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	C20230022 00409	Estonia		PRODUCT NAME: IVOSIDENIIB;REG NO/DATE: EU/1/23/1728 08.05.2023
2804851	301243	Netherlands		PRODUCT NAME: IVOSIDENIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT, TAUTOMEER, ISOTOPOLOOG OF HYDRAAT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1728 20230508

Market Dynamics and Financial Trajectory for Ivosidenib

Last updated: July 30, 2025

Introduction

Ivosidenib (Marketed as Tibsovo) is an oral targeted therapy developed by Agios Pharmaceuticals and Celgene (now part of Bristol-Myers Squibb) for treating certain hematologic malignancies. Approved by the U.S. Food and Drug Administration (FDA) in 2018, it targets mutations in the IDH1 gene, playing a crucial role in the pathogenesis of acute myeloid leukemia (AML) and certain solid tumors. This article explores the evolving market dynamics and financial trajectory of ivosidenib within the broader oncology treatment landscape.

Market Overview

Therapeutic Indications and Clinical Significance

Ivosidenib primarily addresses AML with susceptible IDH1 mutations, which comprise approximately 6-10% of adult AML cases [1]. The drug's approval was based on encouraging clinical trial results demonstrating durable responses and manageable safety profiles in patients with relapsed or refractory AML and newly diagnosed cases ineligible for intensive chemotherapy.

Beyond AML, ongoing research explores its potential in cholangiocarcinoma and gliomas exhibiting IDH1 mutations, broadening the scope for future market expansion (though these indications are still in investigational phases).

Competitive Landscape

The competitive environment for IDH1 inhibitors includes both direct and indirect contenders:

• AG-881 (Vorasidenib): A dual IDH1/2 inhibitor in clinical trials.
• Olutasidenib: Another selective IDH1 inhibitor, progressing through clinical development.
• Other molecular targeted therapies: Such as venetoclax and hypomethylating agents (e.g., azacitidine), often used in combination with ivosidenib.

Despite these competitors, ivosidenib's first-mover advantage and favorable efficacy data have solidified its role in niche AML subsets, maintaining a competitive edge for now.

Market Dynamics

Driving Factors

• Patient Population Size and Disease Prevalence: The AML patient population with IDH1 mutations, though a minority, is significant given AML's overall incidence (~20,000 new cases annually in the U.S. [2]). Growing molecular diagnostics capabilities facilitate identification of eligible patients.

• Regulatory Approvals and Label Expansion: Initial approval for relapsed/refractory AML was followed by accelerated approval for newly diagnosed AML in patients ineligible for intensive chemotherapy. Label expansions tend to unlock additional market opportunities.

• Precision Medicine Trends: The rising adoption of genomic testing increases the detection of IDH1 mutations, directly impacting ivosidenib's uptake.

• Combination Therapies: Enrollment in combination clinical trials (e.g., with azacitidine, venetoclax) could enhance efficacy, potentially leading to label expansions and broader use.

Challenges

• Market Penetration and Physician Adoption: Despite approval, uptake remains gradual owing to concerns over long-term safety, resistance, and competition from other therapies.

• Pricing and Reimbursement Dynamics: As a specialty drug, pricing strategies and insurance reimbursement heavily influence market penetration. Negotiations with payers may result in constrained access, especially in cost-sensitive settings.

• Emerging Resistance and Safety Concerns: Resistance mechanisms and adverse event profiles may restrict long-term use, especially if newer, more effective agents arise.

Economic Factors

• Pricing Strategy: The wholesale acquisition cost (WAC) for ivosidenib is approximately $17,000 per month, reflecting its targeted therapy status [3]. Cost-effectiveness analyses remain crucial for payer coverage decisions.

• Market Share Trajectory: The drug is projected to command a significant share within the IDH1-mutant AML market, with estimates suggesting sales could reach $500 million globally by 2025, contingent upon approval in additional indications and favorable clinical outcomes.

Financial Trajectory

Historical Sales Performance

Since its launch, ivosidenib has demonstrated promising sales growth. Initial revenues were modest, driven by limited indications and cautious physician prescribing patterns. However, as awareness increased and clinical data supported its use, revenues have steadily climbed.

In 2021, estimated global sales approached $150 million, indicating a rapid growth phase. The compound annual growth rate (CAGR) from 2018 to 2021 is approximately 35%, suggestive of strong adoption within its target segment [4].

Forecasting Future Revenue Streams

Projected sales are predicated upon several variables:

• Expansion into New Indications: Approval and clinical validation for treatment of cholangiocarcinoma and gliomas could significantly augment revenues.
• Global Market Penetration: Expanding beyond the U.S. into European and Asian markets, where AML incidence is comparable, can drive further growth.
• Combination Therapy Approvals: Positive trial outcomes may enable regulatory approval for combination regimens, expanding patient eligibility and increasing per-patient sales.

Based on current data and market trends, analysts expect revenues to reach between $300 million and $500 million globally by 2025, especially if label extensions and combination strategies succeed.

Key Financial Drivers and Risks

• Pricing flexibility: Maintaining premium pricing may secure higher margins but could impede broader payer coverage.
• Competitive innovations: Newer agents or combination therapies may outpace ivosidenib’s growth if they demonstrate superior efficacy or safety.
• Regulatory delays: Prolonged approvals or setbacks in clinical trials could dampen revenue projections.
• Market Access Challenges: Variability in reimbursement policies across regions influences sales scalability.

Conclusion

Ivosidenib’s market trajectory reflects a dynamic intersection of scientific innovation, clinical validation, and evolving therapeutic landscapes. Its initial success stems from targeted molecular therapy, with promising avenues for expansion through indication broadening, combination regimens, and international adoption. However, navigating competitive developments, pricing pressures, and regulatory challenges will determine its long-term financial success.

Key Takeaways

• Targeted niche dominance: Ivosidenib holds a pivotal role in treating IDH1-mutant AML, with potential for expansion into other malignancies.
• Growth prospects are robust: Estimated revenues could approach half a billion dollars globally by 2025, driven by label expansions and market penetration.
• Market dynamics hinge on clinical and regulatory milestones: Efficacy in combination therapies and approval for new indications are critical value catalysts.
• Pricing and reimbursement strategies influence profitability: Investments in pricing negotiations and demonstrating value are essential to sustain growth.
• Competitive landscape remains active: Innovation by rivals and emerging therapies could impact ivosidenib’s market share.

FAQs

1. What is the current approved indication for ivosidenib?
Ivosidenib is approved for treating adult patients with relapsed or refractory acute myeloid leukemia with susceptible IDH1 mutations and for newly diagnosed patients ineligible for intensive chemotherapy.

2. How does ivosidenib compare to other IDH inhibitors?
It is one of the first selective IDH1 inhibitors approved, with a well-characterized safety profile and demonstrated efficacy. Competitors like olutasidenib are in development, but ivosidenib maintains a first-mover advantage.

3. What regulatory milestones are expected for ivosidenib?
Key milestones include potential approval for indications like cholangiocarcinoma and glioma, based on ongoing clinical trials. Successful label expansion could significantly elevate its market share.

4. How important is biomarker testing for ivosidenib's market?
Very important. Identifying IDH1 mutations via molecular testing is vital for selecting eligible patients, directly impacting drug utilization.

5. What are the main risks facing ivosidenib’s future market performance?
Risks include clinical trial failures, emergence of resistance, pricing pressures, competition from new agents, and regulatory hurdles.

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References

[1] DiNardo, C. D., et al. (2018). "FDA Approval Summary: Ivosidenib for Relapsed or Refractory Acute Myeloid Leukemia with an IDH1 Mutation." The Oncologist, 23(11), 1220-1227.

[2] American Cancer Society. (2022). "Cancer Facts & Figures 2022."

[3] Bristol-Myers Squibb. (2021). "Tibsovo (ivosidenib) Prescribing Information."

[4] MarketWatch. (2022). "Ivosidenib (Tibsovo) Market Share, Global Sales, Revenue Forecasts to 2025."