Question 1

Is there a generic for Viltolarsen?

Accepted Answer

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

Question 2

What is the reference-listed drug for Viltolarsen?

Accepted Answer

VILTEPSO (NDA 212154, NIPPON SHINYAKU) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Viltolarsen?

Accepted Answer

The Orange Book lists 2 patents against Viltolarsen products, with the earliest listed expiry in 2031. 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 Viltolarsen have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

Viltolarsen is approved in the following dosage form: solution.

Patent	Expires	In	Type
10870676	Aug 31, 2031	in 5 yr 3 mo	SubstanceProductU-3039
9079934	Apr 03, 2034	in 7 yr 11 mo	SubstanceProduct

Viltolarsen

Brand (NDA) products · solution

Marketing exclusivity (1)

Listed patents (2)

Viltolarsen — frequently asked questions

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