VORANIGO Drug Patent Profile

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Which patents cover Voranigo, and what generic alternatives are available?

Voranigo is a drug marketed by Servier and is included in one NDA. There are four patents protecting this drug.

This drug has ninety-two patent family members in thirty-six countries.

The generic ingredient in VORANIGO is vorasidenib. One supplier is listed for this compound. Additional details are available on the vorasidenib profile page.

DrugPatentWatch^® Generic Entry Outlook for Voranigo

Voranigo will be eligible for patent challenges on August 6, 2028. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 6, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for VORANIGO

International Patents:	92
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in VORANIGO?	VORANIGO excipients list
DailyMed Link:	VORANIGO at DailyMed

Drug patent expirations by year for VORANIGO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VORANIGO

Generic Entry Date for VORANIGO^: ⤷ Sign Up* 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 NDA: 218784 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.

US Patents and Regulatory Information for VORANIGO

VORANIGO is protected by four US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VORANIGO is ⤷ Sign Up.

This potential generic entry date is based on 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.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting VORANIGO

Therapeutically active compounds and their methods of use
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 OR IDH2 MUTATION OR COMBINATION THEREOF FOLLOWING SURGERY, WHEREIN THE CANCER IS GRADE 2 ASTROCYTOMA OR OLIGODENDROGLIOMA

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF TREATING A GLIOMA CHARACTERIZED BY AN IDHI MUTATION FOLLOWING SURGERY, WHEREIN THE GLIOMA IS GRADE 2 ASTROCYTOMA OR OLIGODENDROGLIOMA

Therapeutically active compounds and their methods of use
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

FDA Regulatory Exclusivity protecting VORANIGO

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
Exclusivity Expiration: ⤷ Sign Up

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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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	218784-002	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		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 VORANIGO

See the table below for patents covering VORANIGO around the world.

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Country	Patent Number	Title	Estimated Expiration
Brazil	112020008598	cocristais, suas composições farmacêuticas e métodos de tratamento envolvendo os mesmos	⤷ Sign Up
China	118359585	共晶体、其药物组合物以及涉及其的治疗方法 (Co-crystals, pharmaceutical compositions thereof, and methods of treatment involving same)	⤷ Sign Up
Philippines	12020550462	COCRYSTALS, PHARMACEUTICAL COMPOSITIONS THEREOF, AND METHODS OF TREATMENT INVOLVING SAME	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration