Question 1

Is there a generic for Lutetium lu-177 vipivotide tetraxetan?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Lutetium lu-177 vipivotide tetraxetan. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Lutetium lu-177 vipivotide tetraxetan?

Accepted Answer

PLUVICTO (NDA 215833, NOVARTIS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Lutetium lu-177 vipivotide tetraxetan?

Accepted Answer

The Orange Book lists 5 patents against Lutetium lu-177 vipivotide tetraxetan products, with the earliest listed expiry in 2028. 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 Lutetium lu-177 vipivotide tetraxetan have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Lutetium lu-177 vipivotide tetraxetan. 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 Lutetium lu-177 vipivotide tetraxetan are approved?

Accepted Answer

Lutetium lu-177 vipivotide tetraxetan is approved in the following dosage form: solution.

Patent	Expires	In	Type
11318121	Aug 15, 2028	in 2 yr 2 mo	SubstanceProductU-4169
10406240	Aug 15, 2028	in 2 yr 2 mo	SubstanceProductU-4169
11951190	Nov 12, 2035	in 9 yr 6 mo	U-4169
10398791	Mar 23, 2036	in 9 yr 11 mo	SubstanceProduct
12208102	Sep 18, 2041	in 15 yr 6 mo	U-4169

Lutetium lu-177 vipivotide tetraxetan

Brand (NDA) products · solution

Marketing exclusivity (2)

Listed patents (5)

Lutetium lu-177 vipivotide tetraxetan — frequently asked questions

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