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Last Updated: January 24, 2020

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TIBSOVO Drug Profile

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When do Tibsovo patents expire, and what generic alternatives are available?

Tibsovo is a drug marketed by Agios Pharms Inc and is included in one NDA. There are four patents protecting this drug.

This drug has sixty-six patent family members in thirty-three countries.

The generic ingredient in TIBSOVO is ivosidenib. One supplier is listed for this compound. Additional details are available on the ivosidenib profile page.

US ANDA Litigation and 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
Drug patent expirations by year for TIBSOVO
Drug Prices for TIBSOVO

See drug prices for TIBSOVO

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
National Cancer Institute (NCI)Phase 2
CStone PharmaceuticalsPhase 1
National Cancer Institute (NCI)Phase 1

See all TIBSOVO clinical trials

Synonyms for TIBSOVO
(2S)-1-(4-Cyano-2-pyridinyl)-5-oxo-L-prolyl-2-(2-chlorophenyl)-N-(3,3-difluorocyclobutyl)-N2-(5-fluoro-3-pyridinyl)-glycinamide
(2S)-N-[(1S)-1-(2-chlorophenyl)-2-[(3,3-difluorocyclobutyl)amino]-2-oxoethyl]-1-(4-cyanopyridin-2-yl)-N-(5-fluoropyridin-3-yl)-5-oxopyrrolidine-2-carboxamide
(S)-N-((S)-1-(2-chlorophenyl)-2-((3,3-difluorocyclobutyl)amino)-2-oxoethyl)-1-(4-cyanopyridin-2-yl)-N-(5-fluoropyridin-3-yl)-5-oxopyrrolidine-2-carboxamide
(S)-N-((S)-1-(2-chlorophenyl)-2-(3,3-difluorocyclobutylamino)-2-oxoethyl)-1-(4-cyanopyridin-2-yl)-N-
(S)-N-((S)-1-(2-chlorophenyl)-2-(3,3-difluorocyclobutylamino)-2-oxoethyl)-1-(4-cyanopyridin-2-yl)-N-(5-fluoropyridin-3-yl)-5-oxopyrrolidine-2-carboxamide
1448347-49-6
A14386
AG-120
ag-120-Ivosidenib
AG120
AS-35058
CHEMBL3989958
CS-5122
D11090
EX-A992
Glycinamide, 1-(4-cyano-2-pyridinyl)-5-oxo-L-prolyl-2-(2-chlorophenyl)-N-(3,3-difluorocyclobutyl)-N2-(5-fluoro-3-pyridinyl)-, (2S)-
GTPL9217
HY-18767
Ivosidenib
Ivosidenib (AG-120)
Ivosidenib (USAN/INN)
Ivosidenib [INN]
Ivosidenib [USAN]
Ivosidenib [WHO-DD]
MFCD29036964
NCGC00476170-04
NCGC00476170-06
Q2PCN8MAM6
RG120
s8206
SCHEMBL15122512
UNII-Q2PCN8MAM6
ZINC205136523

US Patents and Regulatory Information for TIBSOVO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Agios Pharms Inc TIBSOVO ivosidenib TABLET;ORAL 211192-001 Jul 20, 2018 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Agios Pharms Inc TIBSOVO ivosidenib TABLET;ORAL 211192-001 Jul 20, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Agios Pharms Inc TIBSOVO ivosidenib TABLET;ORAL 211192-001 Jul 20, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Agios Pharms Inc TIBSOVO ivosidenib TABLET;ORAL 211192-001 Jul 20, 2018 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Agios Pharms Inc TIBSOVO ivosidenib TABLET;ORAL 211192-001 Jul 20, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Agios Pharms Inc TIBSOVO ivosidenib TABLET;ORAL 211192-001 Jul 20, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity 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 verifification 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.