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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

Summary for TIBSOVO

International Patents:	66
US Patents:	4
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	28
Clinical Trials:	3
Patent Applications:	9
Drug Prices:	Drug price information for TIBSOVO
DailyMed Link:	TIBSOVO at DailyMed

See drug prices for TIBSOVO

Generic Entry Opportunity Date for TIBSOVO

NDA:

211192

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
National Cancer Institute (NCI)	Phase 2
CStone Pharmaceuticals	Phase 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			Y	Y
Agios Pharms Inc	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes
Agios Pharms Inc	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes
Agios Pharms Inc	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes			Y	Y
Agios Pharms Inc	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes			Y
Agios Pharms Inc	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes			Y

International Patents for TIBSOVO

Country	Patent Number	Estimated Expiration
Spain	2685746
Japan	2017508805
Argentina	089768
Eurasian Patent Organization	201692271
Chile	2014001891
Philippines	12014501626