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Last Updated: December 23, 2024

Ivosidenib - Generic Drug Details


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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 sixty-two patent family members in forty-three countries.

One supplier is listed for this compound.

Summary for ivosidenib
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ivosidenib
Generic Entry Date for ivosidenib*:
Constraining patent/regulatory exclusivity:
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

SponsorPhase
Servier Bio-Innovation LLCPhase 3
Servier Bio-Innovation LLCPhase 1/Phase 2
Institut de Recherches Internationales ServierPhase 1/Phase 2

See all ivosidenib clinical trials

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 9,968,595 ⤷  Subscribe Y ⤷  Subscribe
Servier TIBSOVO ivosidenib TABLET;ORAL 211192-001 Jul 20, 2018 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Servier TIBSOVO ivosidenib TABLET;ORAL 211192-001 Jul 20, 2018 RX Yes Yes 10,610,125 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for ivosidenib

Country Patent Number Title Estimated Expiration
New Zealand 742480 Combination therapy for treating malignancies ⤷  Subscribe
South Africa 201803166 COMBINATION THERAPY FOR TREATING MALIGNANCIES ⤷  Subscribe
Philippines 12017501419 THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHOD OF USE ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ivosidenib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2804851 2023C/534 Belgium ⤷  Subscribe PRODUCT NAME: IVOSIDENIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT, TAUTOMEER, ISOTOPOLOOG OF HYDRAAT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1728 20230508
2804851 CA 2023 00025 Denmark ⤷  Subscribe PRODUCT NAME: IVOSIDENIB ELLER ET FARMACEUTISK ACCEPTABELT SALT, TAUTOMER, ISOTOPOLOG ELLER HYDRAT DERAF; REG. NO/DATE: EU/1/23/1728 20230508
2804851 LUC00315 Luxembourg ⤷  Subscribe PRODUCT NAME: IVOSIDENIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, TAUTOMER, ISOTOPOLOGUE OR HYDRATE THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/23/1728 20230508
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Ivosidenib Market Analysis and Financial Projection Experimental

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.