Assyro AI

FDA Orange Book · active-ingredient family

Probenecid; sulopenem etzadroxil

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

Reference-listed drug:ORLYNVAH · NDA 213972

1

Brand (NDA)

0

Generics (ANDA)

5

Listed patents

2

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
ORLYNVAHRLDITERUM THERAPNDA 213972—Oct 25, 2024

Marketing exclusivity (2)

  • NCENew chemical entity exclusivity (5 years)

    Oct 25, 2029

    in 3 yr 5 mo

  • GAINQualified infectious disease product exclusivity (adds 5 years)

    Oct 25, 2034

    in 8 yr 6 mo

Listed patents (5)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7795243Jun 03, 2029in 3 yr
SubstanceProductU-4026
12109197Apr 01, 2039in 13 yr
U-4026
11554112Apr 01, 2039in 13 yr
U-4026
12544337Dec 23, 2039in 13 yr 9 mo
ProductU-4026
11478428Dec 23, 2039in 13 yr 9 mo
ProductU-4026

Probenecid; sulopenem etzadroxil — 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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