Assyro AI

Orange Book product · Brand (NDA)

VYZULTA

LATANOPROSTENE BUNOD

Brand (NDA)NDA 207795TE ABRX BAUSCH AND LOMB

At a glance

Nov 02, 2017

Approved

Brand (NDA)

Application

AB

TE code

1

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 02, 2017

    8 yr 9 mo ago

  2. Today

  3. Patent 8058467 expires

    Listed drug substance patent expiration.

    Feb 21, 2029

    in 2 yr 9 mo

Pharmaceutical detail

Active ingredient

LATANOPROSTENE BUNOD

Strength

0.024%

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

AB

Application

NDA 207795

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

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 (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8058467Feb 21, 2029in 2 yr 9 mo
SubstanceU-2144
Agent CTA Background

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