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 nine patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and fifty patent family members in forty countries.
The generic ingredient in TIBSOVO is ivosidenib. Two suppliers are listed for this compound. Additional details are available on the ivosidenib profile page.
DrugPatentWatch® Generic Entry Outlook for Tibsovo
Tibsovo was eligible for patent challenges on July 20, 2022.
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.
There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for TIBSOVO
| International Patents: | 150 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 48 |
| Clinical Trials: | 13 |
| Patent Applications: | 151 |
| Drug Prices: | Drug price information for TIBSOVO |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TIBSOVO |
| What excipients (inactive ingredients) are in TIBSOVO? | TIBSOVO excipients list |
| DailyMed Link: | TIBSOVO at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
| Sponsor | Phase |
|---|---|
| Accord Healthcare, Inc. | Phase 3 |
| Taiho Oncology, Inc. | Phase 3 |
| National Cancer Institute, France | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for TIBSOVO
Paragraph IV (Patent) Challenges for TIBSOVO
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| TIBSOVO | Tablets | ivosidenib | 250 mg | 211192 | 1 | 2022-07-20 |
US Patents and Regulatory Information for TIBSOVO
TIBSOVO is protected by twenty-seven US patents and six FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of TIBSOVO is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Methods and compositions for cell-proliferation-related disorders
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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)
Methods and compositions for cell-proliferation-related disorders
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD FOR TREATING NEWLY DIAGNOSED AML WITH IVOSIDENIB AND AZACITIDINE WHEREIN THE AML HAS AN IDH1 MUTATION CAPABLE OF CONVERTING ALPHA-KETOGLUTARATE TO 2-HYDROXYGLUTARATE (2HG)
Combination therapy for treating malignancies
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD FOR TREATING NEWLY DIAGNOSED AML CHARACTERIZED BY THE PRESENCE OF A MUTANT ALLELE OF IDH1 SELECTED FROM R132H, R132C, R132L, R132V, R132S AND R132GF BY ADMINISTERING IVOSIDENIB AND AZACITIDINE
Therapeutically active compounds and their methods of use
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD FOR TREATING AML BY ADMINISTERING A PHARMACEUTICAL COMPOSITION COMPRISING IVOSIDENIB WHEREIN THE AML IS NEWLY DIAGNOSED AND CHARACTERIZED BY A MUTANT IDH1 AND THE COMPOSITION IS ADMINISTERED IN COMBINATION WITH AZACITIDINE
Pharmaceutical compositions of therapeutically active compounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATING NEWLY DIAGNOSED AML CHARACTERIZED BY THE PRESENCE OF A MUTANT ALLELE OF IDH1 BY ADMINISTERING A ONCE DAILY 500 MG ORAL DOSE OF IVOSIDENIB TO A SUBJECT THAT HAS NOT INGESTED A HIGH-FAT MEAL, IN COMBINATION WITH AZACITIDINE
Therapy for treating malignancies
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD FOR TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WITH IVOSIDENIB IN COMBINATION WITH AZACITIDINE WHEREIN THE CANCER IS NEWLY DIAGNOSED AML
Therapeutically active compositions and their methods of use
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD FOR TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WITH IVOSIDENIB IN COMBINATION WITH AZACITIDINE WHEREIN THE CANCER IS NEWLY DIAGNOSED AML
Therapeutically active compositions and their methods of use
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ACUTE MYELOID LEUKEMIA (AML) WITH AN IDH1 MUTATION
Pharmaceutical compositions of therapeutically active compounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD FOR TREATING AML BY ADMINISTERING A PHARMACEUTICAL COMPOSITION COMPRISING IVOSIDENIB WHEREIN THE AML IS NEWLY DIAGNOSED AND CHARACTERIZED BY A MUTANT IDH1 AND THE COMPOSITION IS ADMINISTERED IN COMBINATION WITH AZACITIDINE
FDA Regulatory Exclusivity protecting TIBSOVO
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
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: ⤷ Try a Trial
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: ⤷ Try a Trial
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: ⤷ Try a Trial
IN COMBINATION WITH AZACITIDINE OR AS MONOTHERAPY FOR THE TREATMENT OFNEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) WITH A SUSCEPTIBLE ISOCITRATE DEHYDROGENASE-1 (IDH1) MUTATION AS DETECTED BY AN FDA-APPROVED TEST IN ADULTS 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY
Exclusivity Expiration: ⤷ 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | ⤷ 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 | ||
| 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 | ||||
| >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 TIBSOVO
| 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 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: ⤷ Try a Trial
Patent: 19246824
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2016021232
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 42072
Estimated Expiration: ⤷ Try a Trial
China
Patent: 6255498
Estimated Expiration: ⤷ Try a Trial
Patent: 2159391
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 6325
Estimated Expiration: ⤷ Try a Trial
Patent: 1691845
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 16492
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 7722
Estimated Expiration: ⤷ Try a Trial
Patent: 3319
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 64796
Estimated Expiration: ⤷ Try a Trial
Patent: 17508805
Estimated Expiration: ⤷ Try a Trial
Patent: 20007313
Estimated Expiration: ⤷ Try a Trial
Patent: 21191785
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 16011810
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 726
Estimated Expiration: ⤷ Try a Trial
Philippines
Patent: 016501790
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 2400737
Estimated Expiration: ⤷ Try a Trial
Patent: 160124914
Estimated Expiration: ⤷ Try a Trial
Patent: 220070066
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 1211
Estimated Expiration: ⤷ Try a Trial
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 |
|---|---|---|---|
| India | 5986DEN2014 | ⤷ Try a Trial | |
| Japan | 2018536636 | 悪性腫瘍を処置するため組合せ療法 | ⤷ Try a Trial |
| China | 102985557 | Methods and compositions for cell-proliferation-related disorders | ⤷ Try a Trial |
| Mexico | 351166 | COMPUESTOS TERAPÉUTICAMENTE ACTIVOS Y SUS MÉTODOS DE USO. (THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE.) | ⤷ Try a Trial |
| Denmark | 3447052 | ⤷ Try a Trial | |
| Japan | 2015044862 | 細胞増殖関連疾患のための方法および組成物 (METHODS AND COMPOSITIONS FOR CELL-PROLIFERATION-RELATED DISORDERS) | ⤷ Try a Trial |
| Eurasian Patent Organization | 201691845 | ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ТЕРАПЕВТИЧЕСКИ АКТИВНЫХ СОЕДИНЕНИЙ | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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.
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