Question 1

Is there a generic for Deucravacitinib?

Accepted Answer

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

Question 2

What is the reference-listed drug for Deucravacitinib?

Accepted Answer

SOTYKTU (NDA 214958, BRISTOL) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Deucravacitinib?

Accepted Answer

The Orange Book lists 4 patents against Deucravacitinib products, with the earliest listed expiry in 2033. 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 Deucravacitinib have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Deucravacitinib. 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 Deucravacitinib are approved?

Accepted Answer

Deucravacitinib is approved in the following dosage form: tablet.

Patent	Expires	In	Type
RE47929	Nov 07, 2033	in 7 yr 6 mo	SubstanceProductU-4452
11021475	Nov 07, 2033	in 7 yr 6 mo	U-3434
10000480	Nov 07, 2033	in 7 yr 6 mo	SubstanceProduct
12521390	Feb 11, 2043	in 16 yr 11 mo	ProductU-3434

Deucravacitinib

Brand (NDA) products · tablet

Marketing exclusivity (2)

Listed patents (4)

Deucravacitinib — frequently asked questions

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