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 nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.Ivosidenib has one hundred and forty-four patent family members in thirty-nine countries.
Summary for ivosidenib
| International Patents: | 144 |
| US Patents: | 9 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 41 |
| Clinical Trials: | 21 |
| Patent Applications: | 311 |
| 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 |
|---|---|
| Alice Mims | Phase 2 |
| Case Comprehensive Cancer Center | Phase 1 |
| M.D. Anderson Cancer Center | Phase 1 |
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 | Y | 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 | Y | 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 | 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 |
|---|---|---|---|
| Mexico | 2018004586 | See Plans and Pricing | |
| Japan | 6805220 | See Plans and Pricing | |
| World Intellectual Property Organization (WIPO) | 2010105243 | See Plans and Pricing | |
| Australia | 2016338557 | See Plans and Pricing | |
| World Intellectual Property Organization (WIPO) | 2013107291 | See Plans and Pricing | |
| Mexico | 346801 | MÉTODOS Y COMPOSICIONES PARA TRASTORNOS RELACIONADOS CON LA PROLIFERACIÓN CELULAR. (METHODS AND COMPOSITIONS FOR CELL-PROLIFERATION-RELATED DISORDERS.) | See Plans and Pricing |
| >Country | >Patent Number | >Title | >Estimated Expiration |
