ENASIDENIB MESYLATE - Generic Drug Details

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What are the generic sources for enasidenib mesylate and what is the scope of patent protection?

Enasidenib mesylate is the generic ingredient in one branded drug marketed by Bristol Myers Squibb and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Enasidenib mesylate has one hundred and eleven patent family members in thirty-nine countries.

One supplier is listed for this compound.

Summary for ENASIDENIB MESYLATE

International Patents:	111
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	26
Clinical Trials:	6
Patent Applications:	260
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ENASIDENIB MESYLATE
What excipients (inactive ingredients) are in ENASIDENIB MESYLATE?	ENASIDENIB MESYLATE excipients list
DailyMed Link:	ENASIDENIB MESYLATE at DailyMed

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

Generic Entry Date for ENASIDENIB MESYLATE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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 ENASIDENIB MESYLATE

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

Sponsor	Phase
Children's Oncology Group	Phase 2
City of Hope Medical Center	Phase 1
National Cancer Institute (NCI)	Phase 1

See all ENASIDENIB MESYLATE clinical trials

Pharmacology for ENASIDENIB MESYLATE

Drug Class	Isocitrate Dehydrogenase 2 Inhibitor
Mechanism of Action	Isocitrate Dehydrogenase 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ENASIDENIB MESYLATE

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

US Patents and Regulatory Information for ENASIDENIB MESYLATE

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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
Bristol Myers Squibb	IDHIFA	enasidenib mesylate	TABLET;ORAL	209606-002	Aug 1, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Bristol Myers Squibb	IDHIFA	enasidenib mesylate	TABLET;ORAL	209606-002	Aug 1, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Bristol Myers Squibb	IDHIFA	enasidenib mesylate	TABLET;ORAL	209606-001	Aug 1, 2017		RX	Yes	No	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Bristol Myers Squibb	IDHIFA	enasidenib mesylate	TABLET;ORAL	209606-002	Aug 1, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Bristol Myers Squibb	IDHIFA	enasidenib mesylate	TABLET;ORAL	209606-001	Aug 1, 2017		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Bristol Myers Squibb	IDHIFA	enasidenib mesylate	TABLET;ORAL	209606-001	Aug 1, 2017		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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 ENASIDENIB MESYLATE

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	2406389	PROCÉDÉS ET COMPOSITIONS POUR DES TROUBLES LIÉS À LA PROLIFÉRATION CELLULAIRE (METHODS AND COMPOSITIONS FOR CELL-PROLIFERATION-RELATED DISORDERS)	⤷ Sign Up
China	105916507	治疗活性化合物及其使用方法 (Therapeutically active compounds and their methods of use)	⤷ Sign Up
European Patent Office	2800743	COMPOSÉS THÉRAPEUTIQUEMENT ACTIFS ET LEURS PROCÉDÉS D'UTILISATION (THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE)	⤷ Sign Up
Japan	2012520327		⤷ Sign Up
Taiwan	I701242		⤷ Sign Up
China	108524505	用于细胞增殖相关病症的方法和组合物 (Methods and compositions for cell-proliferation-related disorders)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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