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Generated: November 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 211192

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NDA 211192 describes TIBSOVO, which is a drug marketed by Agios Pharms Inc and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the TIBSOVO profile page.

The generic ingredient in TIBSOVO is ivosidenib. One supplier is listed for this compound. Additional details are available on the ivosidenib profile page.
Summary for 211192
Tradename:TIBSOVO
Applicant:Agios Pharms Inc
Ingredient:ivosidenib
Patents:3
Generic Entry Opportunity Date for 211192
Generic Entry Date for 211192*:
Constraining patent/regulatory exclusivity:
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.

Suppliers and Packaging for NDA: 211192
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TIBSOVO ivosidenib TABLET;ORAL 211192 NDA Agios Pharmaceuticals, Inc. 71334-100 71334-100-01 60 TABLET, FILM COATED in 1 BOTTLE (71334-100-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Jul 20, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 20, 2025
Regulatory Exclusivity Use: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
Regulatory Exclusivity Expiration:Jul 20, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Sign UpPatent Expiration:Aug 19, 2033Product Flag?YSubstance Flag?YDelist Request?
Patented Use:A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS ACUTE MYELOGENOUS LEUKEMIA (AML)

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