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FDA Orange Book · active-ingredient family

Plazomicin sulfate

Plazomicin sulfate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:ZEMDRI · NDA 210303

1

Brand (NDA)

0

Generics (ANDA)

4

Listed patents

2

Exclusivity periods

Brand (NDA) products · solution

ProductApplicantApplicationTEApproved
ZEMDRIRLDCIPLA USANDA 210303—Jun 25, 2018

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
9688711Nov 21, 2028in 2 yr 6 mo
SubstanceU-2328
9266919Nov 21, 2028in 2 yr 6 mo
U-2328
8822424Nov 21, 2028in 2 yr 6 mo
Product
8383596Jun 25, 2032in 6 yr 1 mo
SubstanceU-2328

Plazomicin sulfate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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