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FDA Orange Book · active-ingredient family

Meropenem; vaborbactam

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

Reference-listed drug:VABOMERE · NDA 209776

1

Brand (NDA)

0

Generics (ANDA)

10

Listed patents

2

Exclusivity periods

Brand (NDA) products · powder

ProductApplicantApplicationTEApproved
VABOMERERLDREMPEXNDA 209776—Aug 29, 2017

Marketing exclusivity (2)

  • NCENew chemical entity exclusivity (5 years)

    Aug 29, 2022

    3 yr 10 mo ago

  • GAINQualified infectious disease product exclusivity (adds 5 years)

    Aug 29, 2027

    in 1 yr 3 mo

Listed patents (10)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9694025Aug 08, 2031in 5 yr 3 mo
U-2120
10561675Aug 08, 2031in 5 yr 3 mo
U-2490
10183034Aug 08, 2031in 5 yr 3 mo
U-2490
11007206Aug 08, 2031in 5 yr 3 mo
U-3128
12171772Aug 08, 2031in 5 yr 3 mo
Substance
10172874Aug 08, 2031in 5 yr 3 mo
Product
8680136Aug 29, 2031in 5 yr 3 mo
SubstanceProduct
12478606Jan 08, 2038in 11 yr 9 mo
U-3421
11376237Apr 06, 2039in 13 yr
U-3421
12533342May 20, 2039in 13 yr 1 mo
U-3421

Meropenem; vaborbactam — 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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