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FDA Orange Book · active-ingredient family

Ferric citrate

Ferric citrate is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:AURYXIA · NDA 205874

1

Brand (NDA)

1

Generics (ANDA)

3

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
AURYXIARLDKERYX BIOPHARMSNDA 205874ABSep 05, 2014

Generic (ANDA) products (1)

ProductApplicantApplicationTEApproved
FERRIC CITRATETEVA PHARMS USAANDA 212563ABMar 11, 2026

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8093423Apr 21, 20262 mo ago
U-1577
10300039Jul 21, 2030in 4 yr 2 mo
U-2549
9387191Jul 21, 2030in 4 yr 2 mo
Product

Ferric citrate — 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.