Assyro AI

Orange Book product · Brand (NDA)

XENOVIEW

XENON XE-129 HYPERPOLARIZED

Brand (NDA)NDA 214375RX POLAREAN

At a glance

Dec 23, 2022

Approved

Brand (NDA)

Application

Not listed

TE code

2

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 23, 2022

    3 yr 6 mo ago

  2. Today

  3. Exclusivity ends · NCE

    New chemical entity exclusivity (5 years)

    Dec 23, 2027

    in 1 yr 6 mo

  4. Patent 10583205 expires

    Listed drug product patent expiration.

    Feb 20, 2035

    in 8 yr 10 mo

  5. Patent 11052161 expires

    Listed drug product patent expiration.

    Dec 29, 2035

    in 9 yr 8 mo

Pharmaceutical detail

Active ingredient

XENON XE-129 HYPERPOLARIZED

Strength

N/A

Dosage form

GAS

Route

INHALATION

TE code

Not listed

Application

NDA 214375

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.

Marketing exclusivity (1)

  • NCENew chemical entity exclusivity (5 years)

    Dec 23, 2027

    in 1 yr 6 mo

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10583205Feb 20, 2035in 8 yr 10 mo
Product
11052161Dec 29, 2035in 9 yr 8 mo
Product
Agent CTA Background

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