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Last Updated: December 7, 2022

Ivosidenib - Generic Drug Details


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What are the generic sources for ivosidenib and what is the scope of freedom to operate?

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-four patent family members in thirty-nine countries.

Summary for ivosidenib
International Patents:144
US Patents:9
Tradenames:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 41
Clinical Trials: 21
Patent Applications: 311
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
Recent Clinical Trials for ivosidenib

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

SponsorPhase
Alice MimsPhase 2
Case Comprehensive Cancer CenterPhase 1
M.D. Anderson Cancer CenterPhase 1

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 Y 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 Y 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 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
Mexico 2018004586 See Plans and Pricing
Japan 6805220 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2010105243 See Plans and Pricing
Australia 2016338557 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2013107291 See Plans and Pricing
Mexico 346801 MÉTODOS Y COMPOSICIONES PARA TRASTORNOS RELACIONADOS CON LA PROLIFERACIÓN CELULAR. (METHODS AND COMPOSITIONS FOR CELL-PROLIFERATION-RELATED DISORDERS.) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Dow
McKesson
Medtronic
Baxter
Boehringer Ingelheim
AstraZeneca

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.