You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 25, 2024

Details for New Drug Application (NDA): 211192


✉ Email this page to a colleague

« Back to Dashboard


NDA 211192 describes TIBSOVO, which is a drug marketed by Servier and is included in one NDA. It is available from two suppliers. There are ten patents protecting this drug. Additional details are available on the TIBSOVO profile page.

The generic ingredient in TIBSOVO is ivosidenib. Two suppliers are listed for this compound. Additional details are available on the ivosidenib profile page.
Summary for 211192
Tradename:TIBSOVO
Applicant:Servier
Ingredient:ivosidenib
Patents:10
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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)
TIBSOVO ivosidenib TABLET;ORAL 211192 NDA Servier Pharmaceutical LLC 72694-617 72694-617-60 1 BOTTLE in 1 CARTON (72694-617-60) / 60 TABLET, FILM COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Jul 20, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 25, 2024
Regulatory Exclusivity Use:FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED, LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH AN IDH1 MUTATION AS DETECTED BY AN FDA-APPROVED TEST
Regulatory Exclusivity Expiration:Oct 24, 2026
Regulatory Exclusivity Use:FOR THE TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MYELODYSPLASTIC SYNDROMES(MDS) WITH A SUSCEPTIBLE ISOCITRATE DEHYDROGENASE-1 (IDH1) MUTATION AS DETECTED BY AN FDA-APPROVED TEST
Regulatory Exclusivity Expiration:May 25, 2025
Regulatory Exclusivity Use:IN COMBINATION WITH AZACITIDINE OR AS MONOTHERAPY FOR THE TREATMENT OF NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) WITH A SUSCEPTIBLE ISOCITRATE DEHYDROGENASE-1 (IDH1) MUTATION AS DETECTED BY AN FDA-APPROVED TEST IN ADULTS 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.