Assyro AI

Orange Book product · Brand (NDA)

TEKAMLO

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE

Brand (NDA)NDA 022545DISCN NOVARTIS

At a glance

Aug 26, 2010

Approved

Brand (NDA)

Application

Not listed

TE code

1

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 26, 2010

    16 yr 1 mo ago

  2. Today

  3. Patent 8613949 expires

    Listed drug product patent expiration.

    Dec 21, 2029

    in 3 yr 7 mo

Pharmaceutical detail

Active ingredient

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE

Strength

EQ 150MG BASE;EQ 5MG BASE

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 022545

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 (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8613949Dec 21, 2029in 3 yr 7 mo
Product
Agent CTA Background

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