Ivosidenib - Generic Drug Details
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What are the generic sources for ivosidenib and what is the scope of patent protection?
Ivosidenib
is the generic ingredient in one branded drug marketed by Servier and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.Ivosidenib has one hundred and forty-eight patent family members in forty countries.
Two suppliers are listed for this compound.
Summary for ivosidenib
International Patents: | 148 |
US Patents: | 9 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 42 |
Clinical Trials: | 22 |
Patent Applications: | 363 |
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 |
Recent Clinical Trials for ivosidenib
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Cancer Research UK & UCL Cancer Trials Centre | Phase 3 |
Accord Healthcare, Inc. | Phase 3 |
Taiho Oncology, Inc. | Phase 3 |
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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Servier | TIBSOVO | ivosidenib | TABLET;ORAL | 211192-001 | Jul 20, 2018 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Servier | TIBSOVO | ivosidenib | TABLET;ORAL | 211192-001 | Jul 20, 2018 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for ivosidenib
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 2019283951 | THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE | See Plans and Pricing |
Serbia | 62829 | KOMBINOVANA TERAPIJA ZA LEČENJE MALIGNITETA (COMBINATION THERAPY FOR TREATING MALIGNANCIES) | See Plans and Pricing |
Ukraine | 122324 | ТЕРАПЕВТИЧНО АКТИВНІ СПОЛУКИ І СПОСОБИ ЇХ ЗАСТОСУВАННЯ | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |