Question 1

Is there a generic for Vorasidenib?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Vorasidenib. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Vorasidenib?

Accepted Answer

VORANIGO (NDA 218784, SERVIER) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Vorasidenib?

Accepted Answer

The Orange Book lists 5 patents against Vorasidenib products, with the earliest listed expiry in 2034. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Vorasidenib have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 4 marketing-exclusivity periods for Vorasidenib. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Vorasidenib are approved?

Accepted Answer

Vorasidenib is approved in the following dosage form: tablet.

Patent	Expires	In	Type
12433895	Jul 11, 2034	in 8 yr 2 mo	U-4286
10172864	Jul 11, 2034	in 8 yr 2 mo	SubstanceProduct
9579324	Jul 11, 2034	in 8 yr 2 mo	Substance
11844758	Dec 04, 2035	in 9 yr 7 mo	U-3977
11345677	Jan 16, 2039	in 12 yr 9 mo	SubstanceProductU-3978

Vorasidenib

Brand (NDA) products · tablet

Marketing exclusivity (4)

Listed patents (5)

Vorasidenib — frequently asked questions

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