Details for New Drug Application (NDA): 218784
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NDA 218784 describes VORANIGO, which is a drug marketed by Servier and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the VORANIGO profile page.
The generic ingredient in VORANIGO is vorasidenib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the vorasidenib profile page.
The generic ingredient in VORANIGO is vorasidenib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the vorasidenib profile page.
Summary for 218784
| Tradename: | VORANIGO |
| Applicant: | Servier |
| Ingredient: | vorasidenib |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 218784
Generic Entry Date for 218784*:
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.
Pharmacology for NDA: 218784
Suppliers and Packaging for NDA: 218784
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VORANIGO | vorasidenib | TABLET;ORAL | 218784 | NDA | Servier Pharmaceuticals LLC | 72694-728 | 72694-728-40 | 1 BOTTLE in 1 CARTON (72694-728-40) / 30 TABLET, FILM COATED in 1 BOTTLE |
| VORANIGO | vorasidenib | TABLET;ORAL | 218784 | NDA | Servier Pharmaceuticals LLC | 72694-879 | 72694-879-10 | 1 BOTTLE in 1 CARTON (72694-879-10) / 30 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Aug 6, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 6, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Aug 6, 2031 | ||||||||
| Regulatory Exclusivity Use: | 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 | ||||||||
| Patent: | 10,172,864 | Patent Expiration: | Jul 11, 2034 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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