Assyro AI

Orange Book product · Brand (NDA)

ZEMDRI

PLAZOMICIN SULFATE

Brand (NDA)NDA 210303DISCN CIPLA USA

At a glance

Jun 25, 2018

Approved

Brand (NDA)

Application

Not listed

TE code

4

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 25, 2018

    8 yr 1 mo ago

  2. Exclusivity ends · NCE

    New chemical entity exclusivity (5 years)

    Jun 25, 2023

    3 yr ago

  3. Today

  4. Exclusivity ends · GAIN

    Qualified infectious disease product exclusivity (adds 5 years)

    Jun 25, 2028

    in 2 yr 1 mo

  5. Patent 8822424 expires

    Listed drug product patent expiration.

    Nov 21, 2028

    in 2 yr 6 mo

  6. Patent 9266919 expires

    Listed method-of-use patent (U-2328) expiration.

    Nov 21, 2028

    in 2 yr 6 mo

  7. Patent 9688711 expires

    Listed drug substance patent expiration.

    Nov 21, 2028

    in 2 yr 6 mo

  8. Patent 8383596 expires

    Listed drug substance patent expiration.

    Jun 25, 2032

    in 6 yr 1 mo

Pharmaceutical detail

Active ingredient

PLAZOMICIN SULFATE

Strength

EQ 500MG BASE/10ML (EQ 50MG BASE/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 210303

Product number

001

Marketing status

DISCN

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.

Marketing exclusivity (2)

  • NCENew chemical entity exclusivity (5 years)

    Jun 25, 2023

    3 yr ago

  • GAINQualified infectious disease product exclusivity (adds 5 years)

    Jun 25, 2028

    in 2 yr 1 mo

Listed patents (4)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8822424Nov 21, 2028in 2 yr 6 mo
Product
9266919Nov 21, 2028in 2 yr 6 mo
U-2328
9688711Nov 21, 2028in 2 yr 6 mo
SubstanceU-2328
8383596Jun 25, 2032in 6 yr 1 mo
SubstanceU-2328
Agent CTA Background

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