Ivosidenib - Generic Drug Details
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What are the generic sources for ivosidenib and what is the scope of freedom to operate?
Ivosidenib
is the generic ingredient in one branded drug marketed by Servier and is included in one NDA. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.Ivosidenib has one hundred and sixty-six patent family members in forty-four countries.
One supplier is listed for this compound.
Summary for ivosidenib
International Patents: | 166 |
US Patents: | 10 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 50 |
Clinical Trials: | 28 |
Patent Applications: | 322 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ivosidenib |
What excipients (inactive ingredients) are in ivosidenib? | ivosidenib excipients list |
DailyMed Link: | ivosidenib at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ivosidenib
Generic Entry Date for ivosidenib*:
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.
Recent Clinical Trials for ivosidenib
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Servier Bio-Innovation LLC | Phase 3 |
Servier Bio-Innovation LLC | Phase 1/Phase 2 |
Institut de Recherches Internationales Servier | Phase 1/Phase 2 |
Pharmacology for ivosidenib
Drug Class | Isocitrate Dehydrogenase 1 Inhibitor |
Mechanism of Action | Cytochrome P450 2C9 Inducers Cytochrome P450 3A4 Inducers Isocitrate Dehydrogenase 1 Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for ivosidenib
Paragraph IV (Patent) Challenges for IVOSIDENIB
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
TIBSOVO | Tablets | ivosidenib | 250 mg | 211192 | 1 | 2022-07-20 |
US Patents and Regulatory Information for ivosidenib
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Servier | TIBSOVO | ivosidenib | TABLET;ORAL | 211192-001 | Jul 20, 2018 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Servier | TIBSOVO | ivosidenib | TABLET;ORAL | 211192-001 | Jul 20, 2018 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Servier | TIBSOVO | ivosidenib | TABLET;ORAL | 211192-001 | Jul 20, 2018 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Servier | TIBSOVO | ivosidenib | TABLET;ORAL | 211192-001 | Jul 20, 2018 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Servier | TIBSOVO | ivosidenib | TABLET;ORAL | 211192-001 | Jul 20, 2018 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | Y | Y | ⤷ Try for Free | ||
Servier | TIBSOVO | ivosidenib | TABLET;ORAL | 211192-001 | Jul 20, 2018 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for ivosidenib
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Les Laboratoires Servier | Tibsovo | ivosidenib | EMEA/H/C/005936 Tibsovo in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive standard induction chemotherapy (see section 5.1).Tibsovo monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy. |
Authorised | no | no | yes | 2023-05-04 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ivosidenib
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 6067226 | ⤷ Try for Free | |
World Intellectual Property Organization (WIPO) | 2015138839 | ⤷ Try for Free | |
Israel | 258685 | טיפול משולב לממאירות (Combination therapy for treating malignancies) | ⤷ Try for Free |
Mexico | 2016011810 | COMPOSICIONES FARMACEUTICAS DE COMPUESTOS TERAPEUTICAMENTE ACTIVOS Y SUS METODOS DE USO. (PHARMACEUTICAL COMPOSITIONS OF THERAPEUTICALLY ACTIVE COMPOUNDS.) | ⤷ Try for Free |
Taiwan | 201843136 | Therapeutically active compositions and their methods of use | ⤷ Try for Free |
Lithuania | 3447052 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ivosidenib
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2804851 | C202330033 | Spain | ⤷ Try for Free | PRODUCT NAME: IVOSIDENIB O UNA SAL, TAUTOMERO, ISOTOPOLOGO O HIDRATO FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/23/1728; DATE OF AUTHORISATION: 20230504; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/23/1728; DATE OF FIRST AUTHORISATION IN EEA: 20230504 |
2804851 | LUC00315 | Luxembourg | ⤷ Try for Free | PRODUCT NAME: IVOSIDENIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, TAUTOMER, ISOTOPOLOGUE OR HYDRATE THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/23/1728 20230508 |
2804851 | 30/2023 | Austria | ⤷ Try for Free | PRODUCT NAME: IVOSIDENIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ, TAUTOMER, ISOTOPOLOG ODER HYDRAT DAVON; REGISTRATION NO/DATE: EU/1/23/1728 (MITTEILUNG) 20230508 |
2804851 | 301243 | Netherlands | ⤷ Try for Free | PRODUCT NAME: IVOSIDENIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT, TAUTOMEER, ISOTOPOLOOG OF HYDRAAT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1728 20230508 |
2804851 | C02804851/01 | Switzerland | ⤷ Try for Free | PRODUCT NAME: IVOSIDENIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 69077 13.06.2024 |
2804851 | 2023C/534 | Belgium | ⤷ Try for Free | PRODUCT NAME: IVOSIDENIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT, TAUTOMEER, ISOTOPOLOOG OF HYDRAAT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1728 20230508 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for Ivosidenib
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