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FDA Orange Book · active-ingredient family

Cefepime hydrochloride; enmetazobactam

Cefepime hydrochloride; enmetazobactam is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:EXBLIFEP · NDA 216165

1

Brand (NDA)

0

Generics (ANDA)

2

Listed patents

2

Exclusivity periods

Brand (NDA) products · powder

ProductApplicantApplicationTEApproved
EXBLIFEPRLDORCHID PHARMANDA 216165—Feb 22, 2024

Marketing exclusivity (2)

  • NCENew chemical entity exclusivity (5 years)

    Feb 22, 2029

    in 2 yr 9 mo

  • GAINQualified infectious disease product exclusivity (adds 5 years)

    Feb 22, 2034

    in 7 yr 10 mo

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7687488Dec 03, 2027in 1 yr 6 mo
SubstanceProductU-3851
11124526Nov 07, 2034in 8 yr 6 mo
U-3852

Cefepime hydrochloride; enmetazobactam — frequently asked questions

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

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