Vorasidenib - Generic Drug Details
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What are the generic drug sources for vorasidenib and what is the scope of patent protection?
Vorasidenib
is the generic ingredient in one branded drug marketed by Servier and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Vorasidenib has ninety-two patent family members in thirty-six countries.
One supplier is listed for this compound.
Summary for vorasidenib
| International Patents: | 92 |
| US Patents: | 4 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 6 |
| Patent Applications: | 35 |
| DailyMed Link: | vorasidenib at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for vorasidenib
Generic Entry Date for vorasidenib*:
Constraining patent/regulatory exclusivity:
TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER WITH GRADE 2 ASTROCYTOMA OR OLIGODENDROGLIOMA WITH A SUSCEPTIBLE ISOCITRATE DEHYDROGENASE-1 (IDH1) OR ISOCITRATE DEHYDROGENASE-2 (IDH2) MUTATION FOLLOWING SURGERY INCLUDING BIOPSY, SUB-TOTAL RESECTION, OR GROSS TOTAL RESECTION 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 vorasidenib
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Servier Bio-Innovation LLC | Phase 1 |
| Katy Peters, MD, PhD | Phase 1 |
| Servier | Phase 1 |
US Patents and Regulatory Information for vorasidenib
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Servier | VORANIGO | vorasidenib | TABLET;ORAL | 218784-001 | Aug 6, 2024 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Servier | VORANIGO | vorasidenib | TABLET;ORAL | 218784-001 | Aug 6, 2024 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Servier | VORANIGO | vorasidenib | TABLET;ORAL | 218784-002 | Aug 6, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Servier | VORANIGO | vorasidenib | TABLET;ORAL | 218784-001 | Aug 6, 2024 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Servier | VORANIGO | vorasidenib | TABLET;ORAL | 218784-002 | Aug 6, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Servier | VORANIGO | vorasidenib | TABLET;ORAL | 218784-001 | Aug 6, 2024 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Servier | VORANIGO | vorasidenib | TABLET;ORAL | 218784-001 | Aug 6, 2024 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 vorasidenib
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Mexico | 2016000360 | COMPUESTOS TERAPEUTICAMENTE ACTIVOS Y SUS METODOS DE USO. (THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE.) | ⤷ Sign Up |
| Japan | 2021501766 | 共結晶、その医薬組成物、およびそれを伴う治療方法 | ⤷ Sign Up |
| Taiwan | 201930285 | Cocrystals, pharmaceutical compositions thereof, and methods of treatment involving same | ⤷ Sign Up |
| Denmark | 3019483 | ⤷ Sign Up | |
| South Korea | 102366734 | ⤷ Sign Up | |
| Malaysia | 196418 | THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE | ⤷ Sign Up |
| Hong Kong | 1217948 | 治療活性化合物及其使用方法 (THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
