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Last Updated: June 27, 2022

TIBSOVO Drug Patent Profile


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Which patents cover Tibsovo, and when can generic versions of Tibsovo launch?

Tibsovo is a drug marketed by Servier and is included in one NDA. There are eight patents protecting this drug.

This drug has one hundred and twelve patent family members in thirty-seven countries.

The generic ingredient in TIBSOVO is ivosidenib. Additional details are available on the ivosidenib profile page.

DrugPatentWatch® Generic Entry Outlook for Tibsovo

Tibsovo will be eligible for patent challenges on July 20, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 13, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for TIBSOVO
International Patents:112
US Patents:8
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 39
Clinical Trials: 12
Patent Applications: 113
Drug Prices: Drug price information for TIBSOVO
What excipients (inactive ingredients) are in TIBSOVO?TIBSOVO excipients list
DailyMed Link:TIBSOVO at DailyMed
Drug patent expirations by year for TIBSOVO
Drug Prices for TIBSOVO

See drug prices for TIBSOVO

DrugPatentWatch® Estimated Generic Entry Opportunity Date for TIBSOVO
Generic Entry Date for TIBSOVO*:
Constraining patent/regulatory exclusivity:
NDA:
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 TIBSOVO

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

SponsorPhase
Alice MimsPhase 2
M.D. Anderson Cancer CenterPhase 1
Washington University School of MedicinePhase 2

See all TIBSOVO clinical trials

US Patents and Regulatory Information for TIBSOVO

TIBSOVO is protected by twenty US patents and six FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TIBSOVO is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting TIBSOVO

Pharmaceutical compositions of therapeutically active compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods and compositions for cell-proliferation-related disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML) AND WHERE THE MUTANT IDH1 HAS THE ABILITY TO CONVERT ALPHA-KETOGLUTARATE INTO 2-HYDROXYGLUTARATE (2-HG)

Methods and compositions for cell-proliferation-related disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) AND WHERE THE MUTANT IDH1 HAS THE ABILITY TO CONVERT ALPHA-KETOGLUTARATE INTO 2-HYDROXYGLUTARATE (2-HG)

Therapeutically active compounds and their methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD OF TREATING PREVIOUSLY TREATED, LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA CHARACTERIZED BY AN IDH1 MUTATION

Pharmaceutical compositions of therapeutically active compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD OF TREATING ACUTE MYELOGENOUS LEUKEMIA (AML) IN A SUBJECT BY ADMINISTERING A PHARMACEUTICAL COMPOSITION WHERE THE AML IS CHARACTERIZED BY THE PRESENCE OF A MUTANT ALLELE OF IDH1 AND THE AML IS NEWLY DIAGNOSED

Pharmaceutical compositions of therapeutically active compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD OF TREATING ACUTE MYELOGENOUS LEUKEMIA (AML) IN A SUBJECT BY ADMINISTERING A PHARMACEUTICAL COMPOSITION WHERE THE AML IS CHARACTERIZED BY THE PRESENCE OF A MUTANT ALLELE OF IDH1 AND WHERE THE AML IS RELAPSED/REFRACTORY

Therapy for treating malignancies
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD OF TREATING PREVIOUSLY TREATED, LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA CHARACTERIZED BY THE PRESENCE OF A MUTANT ALLELE OF IDH1 BY ADMINISTERING A ONCE DAILY 500 MG ORAL DOSE TO A SUBJECT THAT HAS NOT INGESTED A HIGH-FAT MEAL

Therapy for treating malignancies
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING NEWLY DIAGNOSED ACUTE MYELOGENOUS LEUKEMIA (AML) CHARACTERIZED BY THE PRESENCE OF A MUTANT ALLELE OF IDH1 BY ADMINISTERING A ONCE DAILY 500 MG ORAL DOSE TO A SUBJECT THAT HAS NOT INGESTED A HIGH-FAT MEAL

Therapy for treating malignancies
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING RELAPSED/REFRACTORY ACUTE MYELOGENOUS LEUKEMIA (AML) CHARACTERIZED BY THE PRESENCE OF A MUTANT ALLELE OF IDH1 BY ADMINISTERING A ONCE DAILY 500 MG ORAL DOSE TO A SUBJECT THAT HAS NOT INGESTED A HIGH-FAT MEAL

Therapeutically active compositions and their methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML)

Therapeutically active compositions and their methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML)

Therapeutically active compositions and their methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS ACUTE MYELOGENOUS LEUKEMIA (AML)

Therapeutically active compositions and their methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHEREIN THE CANCER IS PREVIOUSLY TREATED, LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA

Therapeutically active compositions and their methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML)

Therapeutically active compositions and their methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS ACUTE MYELOGENOUS LEUKEMIA (AML)

Therapeutically active compositions and their methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML)

Therapeutically active compositions and their methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHEREIN THE CANCER IS PREVIOUSLY TREATED, LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA

Pharmaceutical compositions of therapeutically active compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML)

Pharmaceutical compositions of therapeutically active compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML)

Pharmaceutical compositions of therapeutically active compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACUTE MYELOID LEUKEMIA (AML) WITH AN IDH1 MUTATION

FDA Regulatory Exclusivity protecting TIBSOVO

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML) WITH A SUSCEPTIBLE ISOCITRATE DEHYDROGENASE-1 (IDH1) MUTATION AS DETECTED BY AN FDA-APPROVED TEST
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF ADULT PATIENTS WITH NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) WHO ARE >= 75 YEARS OLD OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY
Exclusivity Expiration: See Plans and Pricing

TX OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA WITH A SUSCEPTIBLE ISOCITRATE DEHYDROGENASE-1 MUTATION AS DETECTED BY AN FDA-APPROVED TEST IN ADULT PTS WHO ARE >=75 YRS OLD OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY
Exclusivity Expiration: See Plans and Pricing

FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED, LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH AN IDH1 MUTATION AS DETECTED BY AN FDA-APPROVED TEST
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED, LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH AN ISOCITRATE DEHYDROGENASE-1 (IDH1) MUTATION AS DETECTED BY AN FDA-APPROVED TEST
Exclusivity Expiration: 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
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 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 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 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 TIBSOVO

When does loss-of-exclusivity occur for TIBSOVO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 15229214
Estimated Expiration: See Plans and Pricing

Patent: 19246824
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2016021232
Estimated Expiration: See Plans and Pricing

Canada

Patent: 42072
Estimated Expiration: See Plans and Pricing

China

Patent: 6255498
Estimated Expiration: See Plans and Pricing

Patent: 2159391
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 6325
Estimated Expiration: See Plans and Pricing

Patent: 1691845
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 16492
Estimated Expiration: See Plans and Pricing

Israel

Patent: 7722
Estimated Expiration: See Plans and Pricing

Patent: 3319
Estimated Expiration: See Plans and Pricing

Japan

Patent: 64796
Estimated Expiration: See Plans and Pricing

Patent: 17508805
Estimated Expiration: See Plans and Pricing

Patent: 20007313
Estimated Expiration: See Plans and Pricing

Patent: 21191785
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 16011810
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 726
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 016501790
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 160124914
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 1211
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TIBSOVO around the world.

Country Patent Number Title Estimated Expiration
Japan 6313714 See Plans and Pricing
Spain 2903390 See Plans and Pricing
Taiwan I713847 See Plans and Pricing
Croatia P20220017 See Plans and Pricing
Canada 2755394 PROCEDES ET COMPOSITIONS POUR DES TROUBLES LIES A LA PROLIFERATION CELLULAIRE (METHODS AND COMPOSITIONS FOR CELL-PROLIFERATION-RELATED DISORDERS) See Plans and Pricing
European Patent Office 2804851 DÉRIVÉS DE LACTAMES EN TANT QU'INHIBITEURS D'IDH1 MUTANTS (LACTAM DERIVATES USEFUL AS INHIBITORS OF MUTANT IDH1) See Plans and Pricing
Cyprus 1120651 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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