Assyro AI

Orange Book product · Brand (NDA)

VEPPANU

VEPDEGESTRANT

Brand (NDA)NDA 219835RX ARVINAS OPERATIONS

At a glance

May 01, 2026

Approved

Brand (NDA)

Application

Not listed

TE code

3

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 01, 2026

    2 mo ago

  2. Today

  3. Exclusivity ends · NCE

    New chemical entity exclusivity (5 years)

    May 01, 2031

    in 4 yr 11 mo

  4. Patent 10899742 expires

    Listed method-of-use patent (U-4278) expiration.

    Dec 01, 2037

    in 11 yr 7 mo

  5. Patent 11597720 expires

    Listed drug substance patent expiration.

    Dec 01, 2037

    in 11 yr 7 mo

  6. Patent 10647698 expires

    Listed drug substance patent expiration.

    Jan 30, 2038

    in 11 yr 9 mo

Pharmaceutical detail

Active ingredient

VEPDEGESTRANT

Strength

100MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 219835

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Marketing exclusivity (1)

  • NCENew chemical entity exclusivity (5 years)

    May 01, 2031

    in 4 yr 11 mo

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10899742Dec 01, 2037in 11 yr 7 mo
U-4278
11597720Dec 01, 2037in 11 yr 7 mo
SubstanceProductU-4278
10647698Jan 30, 2038in 11 yr 9 mo
SubstanceProduct
Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.