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FDA Orange Book · active-ingredient family

Durlobactam sodium; durlobactam sodium; sulbactam sodium

Durlobactam sodium; durlobactam sodium; sulbactam sodium is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:XACDURO (COPACKAGED) · NDA 216974

1

Brand (NDA)

0

Generics (ANDA)

4

Listed patents

2

Exclusivity periods

Brand (NDA) products · powder

ProductApplicantApplicationTEApproved
XACDURO (COPACKAGED)RLDENTASIS THERAPNDA 216974—May 23, 2023

Marketing exclusivity (2)

  • NCENew chemical entity exclusivity (5 years)

    May 23, 2028

    in 1 yr 11 mo

  • GAINQualified infectious disease product exclusivity (adds 5 years)

    May 23, 2033

    in 7 yr

Listed patents (4)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9623014Apr 02, 2033in 6 yr 11 mo
U-2840
9309245Apr 02, 2033in 6 yr 11 mo
Substance
10376499Nov 17, 2035in 9 yr 7 mo
ProductU-2840
9968593Nov 17, 2035in 9 yr 7 mo
ProductU-2840

Durlobactam sodium; durlobactam sodium; sulbactam sodium — 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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