Details for New Drug Application (NDA): 211192
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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.
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.
Pharmacology for NDA: 211192
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: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
| Approval Date: | Jul 20, 2018 | TE: | 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 | ||||||||
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