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FDA Orange Book · active-ingredient family

Fosfomycin disodium

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

Reference-listed drug:CONTEPO · NDA 212271

1

Brand (NDA)

0

Generics (ANDA)

3

Listed patents

2

Exclusivity periods

Brand (NDA) products · powder

ProductApplicantApplicationTEApproved
CONTEPORLDMEITHEALNDA 212271—Oct 22, 2025

Marketing exclusivity (2)

  • NPNew product exclusivity (3 years)

    Oct 22, 2028

    in 2 yr 5 mo

  • GAINQualified infectious disease product exclusivity (adds 5 years)

    Oct 22, 2033

    in 7 yr 5 mo

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10086006Oct 12, 2034in 8 yr 5 mo
U-4332
9345717Oct 27, 2034in 8 yr 6 mo
U-4332
11541064Jan 30, 2039in 12 yr 10 mo
U-4331

Fosfomycin disodium — 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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