Question 1

Is there a generic for Voclosporin?

Accepted Answer

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

Question 2

What is the reference-listed drug for Voclosporin?

Accepted Answer

LUPKYNIS (NDA 213716, AURINIA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Voclosporin?

Accepted Answer

The Orange Book lists 3 patents against Voclosporin products, with the earliest listed expiry in 2027. 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 Voclosporin have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Voclosporin. 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 Voclosporin are approved?

Accepted Answer

Voclosporin is approved in the following dosage form: capsule.

Patent	Expires	In	Type
7332472	Oct 17, 2027	in 1 yr 4 mo	SubstanceProductU-3056
11622991	Dec 07, 2037	in 11 yr 8 mo	U-3056
10286036	Dec 07, 2037	in 11 yr 8 mo	U-3056

Voclosporin

Brand (NDA) products · capsule

Marketing exclusivity (1)

Listed patents (3)

Voclosporin — frequently asked questions

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