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Last Updated: March 29, 2023

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 nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ivosidenib has one hundred and forty-eight patent family members in forty countries.

Two suppliers are listed for this compound.

Summary for ivosidenib
Recent Clinical Trials for ivosidenib

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

SponsorPhase
Cancer Research UK & UCL Cancer Trials CentrePhase 3
Accord Healthcare, Inc.Phase 3
Taiho Oncology, Inc.Phase 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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Servier TIBSOVO ivosidenib TABLET;ORAL 211192-001 Jul 20, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Servier TIBSOVO ivosidenib TABLET;ORAL 211192-001 Jul 20, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for ivosidenib

Country Patent Number Title Estimated Expiration
Australia 2019283951 THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE See Plans and Pricing
Serbia 62829 KOMBINOVANA TERAPIJA ZA LEČENJE MALIGNITETA (COMBINATION THERAPY FOR TREATING MALIGNANCIES) See Plans and Pricing
Ukraine 122324 ТЕРАПЕВТИЧНО АКТИВНІ СПОЛУКИ І СПОСОБИ ЇХ ЗАСТОСУВАННЯ See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
Dow
Mallinckrodt
Colorcon
Medtronic
Moodys

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.