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FDA Orange Book · active-ingredient family

Foscarnet sodium

Foscarnet sodium is approved as 1 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:FOSCAVIR · NDA 020068

1

Brand (NDA)

7

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · solution

ProductApplicantApplicationTEApproved
FOSCAVIRRLD×2CLINIGEN HLTHCARENDA 020068APSep 27, 1991

Generic (ANDA) products (7)

ProductApplicantApplicationTEApproved
FOSCARNET SODIUMCAPLINANDA 220068APMay 13, 2026
FOSCARNET SODIUMAMNEALANDA 216602APMar 01, 2024
FOSCARNET SODIUMSCIECUREANDA 213987APNov 29, 2023
FOSCARNET SODIUMAVET LIFESCIENCESANDA 213807APJun 05, 2023
FOSCARNET SODIUMGLANDANDA 213001APApr 21, 2021
FOSCARNET SODIUMFRESENIUS KABI USAANDA 212483APJan 29, 2021
FOSCARNET SODIUM×2HOSPIRAANDA 077174May 31, 2005

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Foscarnet sodium — frequently asked questions

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

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.