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Last Updated: March 29, 2024

IVOSIDENIB - Generic Drug Details


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What are the generic drug 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 fifty-seven patent family members in forty-two countries.

Two suppliers are 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
Astellas Pharma US, Inc.Phase 1
Memorial Sloan Kettering Cancer CenterPhase 1
Pierre Fabre MedicamentPhase 3

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Servier TIBSOVO ivosidenib TABLET;ORAL 211192-001 Jul 20, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Servier TIBSOVO ivosidenib TABLET;ORAL 211192-001 Jul 20, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
>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
Poland 3447052 ⤷  Try a Trial
Japan 2020007313 治療活性化合物の医薬組成物 (PHARMACEUTICAL COMPOSITIONS OF THERAPEUTICALLY ACTIVE COMPOUNDS) ⤷  Try a Trial
Japan 2021038263 治療上活性な化合物およびそれらの使用方法 (THERAPEUTICALLY ACTIVE COMPOSITIONS AND THEIR METHODS OF USE) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for IVOSIDENIB

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2804851 301243 Netherlands ⤷  Try a Trial PRODUCT NAME: IVOSIDENIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT, TAUTOMEER, ISOTOPOLOOG OF HYDRAAT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1728 20230508
2804851 C20230022 00409 Estonia ⤷  Try a Trial PRODUCT NAME: IVOSIDENIIB;REG NO/DATE: EU/1/23/1728 08.05.2023
2804851 2023C/534 Belgium ⤷  Try a Trial PRODUCT NAME: IVOSIDENIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT, TAUTOMEER, ISOTOPOLOOG OF HYDRAAT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1728 20230508
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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