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 ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ivosidenib has one hundred and sixty-two patent family members in forty-three countries.

One supplier is listed for this compound.

Summary for ivosidenib

International Patents:	162
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	28
Patent Applications:	322
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ivosidenib

Generic Entry Date for ivosidenib^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: 9,968,595 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 ivosidenib

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

Sponsor	Phase
Servier Bio-Innovation LLC	Phase 3
Institut de Recherches Internationales Servier	Phase 1/Phase 2
Servier Bio-Innovation LLC	Phase 1/Phase 2

See all ivosidenib clinical trials

Pharmacology for ivosidenib

Drug Class	Isocitrate Dehydrogenase 1 Inhibitor
Mechanism of Action	Cytochrome P450 2C9 Inducers Cytochrome P450 3A4 Inducers Isocitrate Dehydrogenase 1 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ivosidenib

L01XX	Other antineoplastic agents
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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

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Glossary

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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	9,968,595	⤷ Subscribe	Y			⤷ Subscribe
Servier	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Servier	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes	10,980,788	⤷ Subscribe				⤷ Subscribe
>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 ivosidenib

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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 ivosidenib

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	3985001	COMPOSITION PHARMACEUTIQUE UTILE POUR INHIBER LE IDH1 (PHARMACEUTICAL COMPOSITION USEFUL IN INHIBITING IDH1)	⤷ Subscribe
Lithuania	2804851		⤷ Subscribe
Taiwan	I713847		⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ivosidenib

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2804851	C20230022 00409	Estonia	⤷ Subscribe	PRODUCT NAME: IVOSIDENIIB;REG NO/DATE: EU/1/23/1728 08.05.2023
2804851	CR 2023 00025	Denmark	⤷ Subscribe	PRODUCT NAME: IVOSIDENIB ELLER ET FARMACEUTISK ACCEPTABELT SALT, TAUTOMER, ISOTOPOLOG ELLER HYDRAT DERAF; REG. NO/DATE: EU/1/23/1728 20230508
2804851	122023000051	Germany	⤷ Subscribe	PRODUCT NAME: LVOSIDENIB ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ, TAUTOMER, ISOTOPOLOG ODER HYDRAT DAVON; REGISTRATION NO/DATE: EU/1/23/1728 20230504
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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