Assyro AI

Orange Book product · Brand (NDA)

FOCINVEZ

FOSAPREPITANT DIMEGLUMINE

Brand (NDA)NDA 216686RX STERISCIENCE

At a glance

Aug 22, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

2

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 22, 2023

    2 yr 10 mo ago

  2. Today

  3. Patent 11065265 expires

    Listed drug product patent expiration.

    Jan 11, 2039

    in 12 yr 9 mo

  4. Patent 12042504 expires

    Listed drug product patent expiration.

    Jan 11, 2039

    in 12 yr 9 mo

Pharmaceutical detail

Active ingredient

FOSAPREPITANT DIMEGLUMINE

Strength

EQ 150MG BASE/50ML (EQ 3MG BASE/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 216686

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 (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11065265Jan 11, 2039in 12 yr 9 mo
Product
12042504Jan 11, 2039in 12 yr 9 mo
Product
Agent CTA Background

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