Assyro AI

Orange Book product · Brand (NDA)

DUTREBIS

LAMIVUDINE; RALTEGRAVIR POTASSIUM

Brand (NDA)NDA 206510DISCN MERCK SHARP DOHME

At a glance

Feb 06, 2015

Approved

Brand (NDA)

Application

Not listed

TE code

2

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 06, 2015

    11 yr 6 mo ago

  2. Today

  3. Patent 7754731 expires

    Listed drug substance patent expiration.

    Mar 11, 2029

    in 2 yr 9 mo

  4. Patent 7754731*PED expires

    Listed listed patent expiration.

    Sep 11, 2029

    in 3 yr 3 mo

Pharmaceutical detail

Active ingredient

LAMIVUDINE; RALTEGRAVIR POTASSIUM

Strength

150MG;EQ 300MG BASE

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 206510

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

This is a brand (NDA) product. Other products sharing this active ingredient are listed below.

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7754731Mar 11, 2029in 2 yr 9 mo
SubstanceProductU-1663
7754731*PEDSep 11, 2029in 3 yr 3 mo
Agent CTA Background

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