Assyro AI

Orange Book product · Brand (NDA)

VITEKTA

ELVITEGRAVIR

Brand (NDA)NDA 203093DISCN GILEAD SCIENCES INC

At a glance

Sep 24, 2014

Approved

Brand (NDA)

Application

Not listed

TE code

6

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 24, 2014

    11 yr 11 mo ago

  2. Today

  3. Patent 7176220 expires

    Listed drug substance patent expiration.

    Aug 27, 2026

    in 2 mo

  4. Patent 7635704 expires

    Listed drug substance patent expiration.

    Oct 26, 2026

    in 4 mo

  5. Patent 8981103 expires

    Listed drug substance patent expiration.

    Oct 26, 2026

    in 4 mo

  6. Patent 7176220*PED expires

    Listed listed patent expiration.

    Feb 27, 2027

    in 8 mo

  7. Patent 7635704*PED expires

    Listed listed patent expiration.

    Apr 26, 2027

    in 10 mo

  8. Patent 8981103*PED expires

    Listed listed patent expiration.

    Apr 26, 2027

    in 10 mo

Pharmaceutical detail

Active ingredient

ELVITEGRAVIR

Strength

85MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 203093

Product number

001

Marketing status

DISCN

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.

Listed patents (6)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7176220Aug 27, 2026in 2 mo
SubstanceProductU-257
7635704Oct 26, 2026in 4 mo
SubstanceProductU-257
8981103Oct 26, 2026in 4 mo
SubstanceProduct
7176220*PEDFeb 27, 2027in 8 mo
7635704*PEDApr 26, 2027in 10 mo
8981103*PEDApr 26, 2027in 10 mo
Agent CTA Background

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