Question 1

Is there a generic for Vepdegestrant?

Accepted Answer

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

Question 2

What is the reference-listed drug for Vepdegestrant?

Accepted Answer

VEPPANU (NDA 219835, ARVINAS OPERATIONS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Vepdegestrant?

Accepted Answer

The Orange Book lists 3 patents against Vepdegestrant products, with the earliest listed expiry in 2037. 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 Vepdegestrant have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

Vepdegestrant is approved in the following dosage form: tablet.

Patent	Expires	In	Type
11597720	Dec 01, 2037	in 11 yr 7 mo	SubstanceProductU-4278
10899742	Dec 01, 2037	in 11 yr 7 mo	U-4278
10647698	Jan 30, 2038	in 11 yr 9 mo	SubstanceProduct

Vepdegestrant

Brand (NDA) products · tablet

Marketing exclusivity (2)

Listed patents (3)

Vepdegestrant — frequently asked questions

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