Ivosidenib
Overview
Ivosidenib is a selective inhibitor of the isocitrate dehydrogenase 1 (IDH1) enzyme, which is used in the treatment of cancers with IDH1 mutations. It disrupts the production of oncometabolite 2-hydroxyglutarate, thereby inhibiting tumor growth.
API suppliers (2)
Suppliers of Ivosidenib evidenced by a US FDA Type II Drug Master File or an EU Certificate of Suitability (CEP). Sources: FDA DMF list, EDQM certification database.
2 of 2 hold a GMP certificate on record in the EU or UK registers
- Teva Pharmaceutical Industries Ltd.Israel1 active DMF GMP on record
- Alembic Pharmaceuticals LimitedIndia1 active DMF GMP on record
Patent & exclusivity (US)
Per the FDA Orange Book (1 approved US product), the latest listed US patent on Ivosidenib expires 7 Jun 2039 and exclusivity 24 Oct 2030. Generic API sourcing typically opens up once these lapse.
Therapeutic areas
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