Assyro AI

Orange Book product · Brand (NDA)

MOVANTIK

NALOXEGOL OXALATE

Brand (NDA)NDA 204760RX AVERITAS

At a glance

Sep 16, 2014

Approved

Brand (NDA)

Application

Not listed

TE code

2

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 16, 2014

    11 yr 11 mo ago

  2. Today

  3. Patent 7786133 expires

    Listed drug substance patent expiration.

    Sep 16, 2028

    in 2 yr 3 mo

  4. Patent 9012469 expires

    Listed drug substance patent expiration.

    Apr 02, 2032

    in 5 yr 10 mo

Pharmaceutical detail

Active ingredient

NALOXEGOL OXALATE

Strength

EQ 12.5MG BASE

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 204760

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.

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7786133Sep 16, 2028in 2 yr 3 mo
SubstanceProduct
9012469Apr 02, 2032in 5 yr 10 mo
SubstanceProduct
Agent CTA Background

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