Question 1

Is there a generic for Vimseltinib?

Accepted Answer

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

Question 2

What is the reference-listed drug for Vimseltinib?

Accepted Answer

ROMVIMZA (NDA 219304, DECIPHERA PHARMS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Vimseltinib?

Accepted Answer

The Orange Book lists 12 patents against Vimseltinib 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 Vimseltinib have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 3 marketing-exclusivity periods for Vimseltinib. 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 Vimseltinib are approved?

Accepted Answer

Vimseltinib is approved in the following dosage form: capsule.

Patent	Expires	In	Type
9181223	Mar 14, 2034	in 7 yr 10 mo	SubstanceProduct
12285430	Dec 23, 2039	in 13 yr 9 mo	U-4145
12485120	Dec 23, 2039	in 13 yr 9 mo	U-4145
12582655	Dec 23, 2039	in 13 yr 9 mo	U-4145
11679110	Feb 03, 2040	in 13 yr 10 mo	U-4145
11103507	Feb 03, 2040	in 13 yr 10 mo	U-4145
12528787	Dec 06, 2044	in 18 yr 9 mo	SubstanceProduct
12643883	Dec 06, 2044	in 18 yr 9 mo	SubstanceProduct
12447149	Dec 06, 2044	in 18 yr 9 mo	Product
12617775	Dec 06, 2044	in 18 yr 9 mo	SubstanceProduct
12551483	Dec 06, 2044	in 18 yr 9 mo	Product
12509443	Apr 30, 2045	in 19 yr 2 mo	Product

Vimseltinib

Brand (NDA) products · capsule

Marketing exclusivity (3)

Listed patents (12)

Vimseltinib — frequently asked questions

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