Pharsight

Tibsovo is owned by Servier.

Tibsovo contains Ivosidenib.

Tibsovo has a total of 9 drug patents out of which 0 drug patents have expired.

Tibsovo was authorised for market use on 20 July, 2018.

Tibsovo is available in tablet;oral dosage forms.

Tibsovo can be used as a method of treating a cancer characterized by an idh1 mutation where the cancer is relapsed or refractory acute myeloid leukemia (aml) and where the mutant idh1 has the ability to convert alpha-ketoglutarate into 2-hydroxyglutarate (2-hg); a method of treating a cancer characterized by an idh1 mutation where the cancer is newly diagnosed acute myeloid leukemia (aml) and where the mutant idh1 has the ability to convert alpha-ketoglutarate into 2-hydroxyglutarate (2-hg), a method of treating acute myelogenous leukemia (aml) in a subject by administering a pharmaceutical composition where the aml is characterized by the presence of a mutant allele of idh1 and the aml is newly diagnosed; a method of treating acute myelogenous leukemia (aml) in a subject by administering a pharmaceutical composition where the aml is characterized by the presence of a mutant allele of idh1 and where the aml is relapsed/refractory, a method of treating a cancer characterized by an idh1 mutation where the cancer is newly diagnosed acute myeloid leukemia (aml); a method of treating a cancer characterized by an idh1 mutation where the cancer is acute myelogenous leukemia (aml); a method of treating a cancer characterized by an idh1 mutation where the cancer is relapsed or refractory acute myeloid leukemia (aml); a method of treating a cancer characterized by an idh1 mutation wherein the cancer is previously treated, locally advanced or metastatic cholangiocarcinoma, a method for treating newly diagnosed aml characterized by the presence of a mutant allele of idh1 selected from r132h, r132c, r132l, r132v, r132s and r132gf by administering ivosidenib and azacitidine, a method of treating previously treated, locally advanced or metastatic cholangiocarcinoma characterized by an idh1 mutation, a method of treating previously treated, locally advanced or metastatic cholangiocarcinoma characterized by the presence of a mutant allele of idh1 by administering a once daily 500 mg oral dose to a subject that has not ingested a high-fat meal; treating newly diagnosed acute myelogenous leukemia (aml) characterized by the presence of a mutant allele of idh1 by administering a once daily 500 mg oral dose to a subject that has not ingested a high-fat meal; treating relapsed/refractory acute myelogenous leukemia (aml) characterized by the presence of a mutant allele of idh1 by administering a once daily 500 mg oral dose to a subject that has not ingested a high-fat meal, a method of treating a cancer characterized by an idh1 mutation where the cancer is newly diagnosed acute myeloid leukemia (aml); a method of treating a cancer characterized by an idh1 mutation where the cancer is relapsed or refractory acute myeloid leukemia (aml); treatment of acute myeloid leukemia (aml) with an idh1 mutation, a method of treating a cancer characterized by an idh1 mutation where the cancer is newly diagnosed acute myeloid leukemia (aml); a method of treating a cancer characterized by an idh1 mutation where the cancer is relapsed or refractory acute myeloid leukemia (aml); a method of treating a cancer characterized by an idh1 mutation where the cancer is acute myelogenous leukemia (aml); a method of treating a cancer characterized by an idh1 mutation wherein the cancer is previously treated, locally advanced or metastatic cholangiocarcinoma.

Drug patent challenges can be filed against Tibsovo from July, 2022.

The generics of Tibsovo are possible to be released after 07 June, 2039.

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US9850277	SERVIER	Therapeutically active compositions and their methods of use	Jan, 2033 (9 years from now)
US9474779	SERVIER	Therapeutically active compositions and their methods of use	Aug, 2033 (10 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10610125	SERVIER	Methods and compositions for cell-proliferation-related disorders	Jun, 2030 (7 years from now)
US10717764	SERVIER	Therapeutically active compounds and their methods of use	Jan, 2033 (9 years from now)
US10799490	SERVIER	Pharmaceutical compositions of therapeutically active compounds	Mar, 2035 (12 years from now)
US10449184	SERVIER	Pharmaceutical compositions of therapeutically active compounds	Mar, 2035 (12 years from now)
US9968595	SERVIER	Pharmaceutical compositions of therapeutically active compounds	Mar, 2035 (12 years from now)
US10653710	SERVIER	Combination therapy for treating malignancies	Oct, 2036 (13 years from now)
US10980788	SERVIER	Therapy for treating malignancies	Jun, 2039 (16 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Jul 20, 2023
Orphan Drug Exclusivity (ODE)	Aug 25, 2028
New Indication (I)	May 25, 2025

Drugs and Companies using IVOSIDENIB ingredient

NCE-1 date: July, 2022

Market Authorisation Date: 20 July, 2018

Treatment: A method of treating a cancer characterized by an idh1 mutation where the cancer is relapsed or refractory acute myeloid leukemia (aml) and where the mutant idh1 has the ability to convert alpha-ketoglutarate into 2-hydroxyglutarate (2-hg); A method of treating a cancer characterized by an idh1 mutation where the cancer is newly diagnosed acute myeloid leukemia (aml) and where the mutant idh1 has the ability to convert alpha-ketoglutarate into 2-hydroxyglutarate (2-hg); A method of treating previously treated, locally advanced or metastatic cholangiocarcinoma characterized by an idh1 mutation; A method of treating acute myelogenous leukemia (aml) in a subject by administering a pharmaceutical composition where the aml is characterized by the presence of a mutant allele of idh1 and the aml is newly diagnosed; A method of treating acute myelogenous leukemia (aml) in a subject by administering a pharmaceutical composition where the aml is characterized by the presence of a mutant allele of idh1 and where the aml is relapsed/refractory; A method of treating a cancer characterized by an idh1 mutation where the cancer is newly diagnosed acute myeloid leukemia (aml); A method of treating a cancer characterized by an idh1 mutation where the cancer is relapsed or refractory acute myeloid leukemia (aml); Treatment of acute myeloid leukemia (aml) with an idh1 mutation; A method for treating newly diagnosed aml characterized by the presence of a mutant allele of idh1 selected from r132h, r132c, r132l, r132v, r132s and r132gf by administering ivosidenib and azacitidine; A method of treating previously treated, locally advanced or metastatic cholangiocarcinoma characterized by the presence of a mutant allele of idh1 by administering a once daily 500 mg oral dose to a subject that has not ingested a high-fat meal; Treating newly diagnosed acute myelogenous leukemia (aml) characterized by the presence of a mutant allele of idh1 by administering a once daily 500 mg oral dose to a subject that has not ingested a high-fat meal; Treating relapsed/refractory acute myelogenous leukemia (aml) characterized by the presence of a mutant allele of idh1 by administering a once daily 500 mg oral dose to a subject that has not ingested a high-fat meal; A method of treating a cancer characterized by an idh1 mutation where the cancer is acute myelogenous leukemia (aml); A method of treating a cancer characterized by an idh1 mutation wherein the cancer is previously treated, locally advanced or metastatic cholangiocarcinoma

Dosage: TABLET;ORAL