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-eight patent family members in forty-five countries.

One supplier is listed for this compound.

Summary for ivosidenib

International Patents:	178
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	41
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:

10,449,184

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 Affaires Mdicales	PHASE2
Institut fr Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest	PHASE2
Servier Deutschland GmbH	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	10,449,184		Y
Servier	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes	9,474,779		Y	Y
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	10,980,788

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
Australia	2019283951
South Korea	102108507
Mexico	2020011104	COMPOSICIONES FARMACEUTICAS DE COMPUESTOS TERAPEUTICAMENTE ACTIVOS Y SUS METODOS DE USO. (PHARMACEUTICAL COMPOSITIONS OF THERAPEUTICALLY ACTIVE COMPOUNDS.)
South Africa	202100373	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	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	122023000051	Germany		PRODUCT NAME: LVOSIDENIB ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ, TAUTOMER, ISOTOPOLOG ODER HYDRAT DAVON; REGISTRATION NO/DATE: EU/1/23/1728 20230504
2804851	CA 2023 00025	Denmark		PRODUCT NAME: IVOSIDENIB ELLER ET FARMACEUTISK ACCEPTABELT SALT, TAUTOMER, ISOTOPOLOG ELLER HYDRAT DERAF; REG. NO/DATE: EU/1/23/1728 20230508
2804851	C20230022 00409	Estonia		PRODUCT NAME: IVOSIDENIIB;REG NO/DATE: EU/1/23/1728 08.05.2023

Market Dynamics and Financial Trajectory for IVOSIDENIB

Last updated: February 15, 2026

Overview

Ivosidenib, marketed as Tibsovo, is an oral, small-molecule inhibitor targeting mutant isocitrate dehydrogenase 1 (IDH1). Approved by the FDA in 2018 for IDH1-mutant acute myeloid leukemia (AML), it is under evaluation for additional indications. The drug’s commercial and clinical trajectory depends on its efficacy, approval pipeline, competitive landscape, and market adoption dynamics.

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Market Size and Growth Potential

• Current Market: The global AML therapeutics market was valued at approximately $1.7 billion in 2022 and is projected to reach $2.4 billion by 2027, with a CAGR of 6.8% (CAGR).

• Ivosidenib’s Market Share: Sales generated from Ivosidenib totaled about $150 million in 2022, a significant share among targeted agents. Its revenue is expected to grow as indications expand and adoption increases.

• Broader Hematologic Malignancies: Sales potential extends into related conditions with IDH1 mutations, including cholangiocarcinoma and other solid tumors in development stages.

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Regulatory and Clinical Development Landscape

• Approved Indication: AML with IDH1 mutations, frontline and relapsed/refractory settings, with increased use in combination therapies.

• Pipeline Progress: Clinical trials are ongoing for:

  • Cholangiocarcinoma: Phase III data expected 2024.
  • Glioma: Early-phase trials for IDH1-mutant gliomas.
  • Other solid tumors: Multiple Phase I/II studies.

• Expanded Indications: Regulatory filings are anticipated following positive trial outcomes, which could substantially increase market size.

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Competitive Environment

• Main Competitors:

  • Enasidenib (IDH2 inhibitor) – FDA-approved for AML; competes indirectly.
  • Other IDH1 inhibitors in development, such as BAY1436032.

• Therapeutic Differentiation:

  • Oral administration.
  • Efficacy in specific subpopulations.
  • Favorable safety profiles.

• Market Challenges:

  • Resistance development.
  • Emergence of combination therapy approaches.
  • High costs and payer considerations.

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Pricing and Reimbursement

• Pricing: The list price is approximately $15,000 per month.
• Reimbursement: Covered broadly by Medicare, Medicaid, and private insurers, with continued negotiations influencing net pricing.
• Cost Growth: The annual treatment cost influences market penetration and patient access.

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Financial Trajectory and Revenue Outlook

Year	Estimated Revenue	Growth Rate	Key Drivers
2022	~$150 million	N/A	Base market, initial indications
2023	~$200 million	33%	Expanded labeling, increased adoption
2024	~$300 million	50%	Anticipated approval in additional indications
2025+	$500 million+	>50%	Launch in other solid tumors, combination therapies

Note: These figures are estimates based on current market data, pipeline progress, and regulatory trends.

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Key Market Drivers

• Expansion into solid tumors with high unmet need.
• Increasing recognition of IDH mutations in various cancers.
• Acceleration of combination therapy strategies.
• Growth in targeted therapy adoption among hematologists and oncologists.

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Risks and Challenges

• Regulatory delays or rejections in new indications.
• Market competition eroding share.
• Pricing pressures and reimbursement constraints.
• Resistance mechanisms diminishing long-term efficacy.

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Key Takeaways

• Ivosidenib’s revenue growth hinges on FDA approvals for new indications and positive clinical trial outcomes.
• The drug faces a competitive landscape but benefits from its oral route and targeted mechanism.
• Market expansion into solid tumors offers significant upside, contingent on trial success.
• Pricing and reimbursement policies will influence overall market penetration.
• Ongoing clinical development is crucial for long-term growth.

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FAQs

1. What are the primary indications for Ivosidenib?
   Currently approved for AML with IDH1 mutations, including relapsed/refractory and newly diagnosed cases.

2. What is the timeline for potential new approvals?
   Phase III results for cholangiocarcinoma are expected in 2024; other indications are in early phases.

3. How does Ivosidenib differentiate from competitors?
   It offers oral administration and a specific targeting of IDH1 mutations, with a favorable safety profile compared to earlier-generation agents.

4. What factors influence Ivosidenib’s pricing and reimbursement?
   Pricing is driven by market demand, competition, and cost-effectiveness analyses, with reimbursement determined by insurer policies and healthcare regulations.

5. What are the main risks to the drug’s financial trajectory?
   Clinical trial failures, regulatory setbacks, emerging competition, and pricing pressures.

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References

1. EvaluatePharma. "Global Oncology Market Report 2022."
2. U.S. Food and Drug Administration. “Tibsovo Prescribing Information,” 2018.
3. IQVIA. "AML Market Data 2022."
4. ClinicalTrials.gov. Database of ongoing drug trials involving Ivosidenib.
5. MarketWatch. “Targeted Cancer Therapies Outlook,” 2023.