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FDA Orange Book · active-ingredient family

Ferric oxyhydroxide

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

Reference-listed drug:VELPHORO · NDA 205109

1

Brand (NDA)

0

Generics (ANDA)

22

Listed patents

2

Exclusivity periods

Brand (NDA) products · tablet, chewable

ProductApplicantApplicationTEApproved
VELPHORORLDVIFOR FRESENIUSNDA 205109—Nov 27, 2013

Marketing exclusivity (2)

  • NPPNew patient population exclusivity (3 years)

    Jul 01, 2027

    in 1 yr 1 mo

  • PEDPediatric exclusivity (adds 6 months)

    Jan 01, 2028

    in 1 yr 7 mo

Listed patents (22)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10695367Nov 13, 2028in 2 yr 5 mo
Product
11013762Nov 13, 2028in 2 yr 5 mo
Product
10933090Nov 13, 2028in 2 yr 5 mo
Product
10925897Nov 13, 2028in 2 yr 5 mo
Product
10682376Nov 13, 2028in 2 yr 5 mo
Product
10925896Nov 13, 2028in 2 yr 5 mo
Product
11013761Nov 13, 2028in 2 yr 5 mo
Product
11013762*PEDMay 13, 2029in 2 yr 11 mo
10925896*PEDMay 13, 2029in 2 yr 11 mo
10925897*PEDMay 13, 2029in 2 yr 11 mo
10933090*PEDMay 13, 2029in 2 yr 11 mo
10682376*PEDMay 13, 2029in 2 yr 11 mo
11013761*PEDMay 13, 2029in 2 yr 11 mo
10695367*PEDMay 13, 2029in 2 yr 11 mo
9561251Jan 23, 2030in 3 yr 8 mo
ProductU-1468
9561251*PEDJul 23, 2030in 4 yr 2 mo
10624855Nov 26, 2034in 8 yr 7 mo
Product
11234938Nov 26, 2034in 8 yr 7 mo
Product
11446252Nov 26, 2034in 8 yr 7 mo
Product
11446252*PEDMay 26, 2035in 9 yr 1 mo
10624855*PEDMay 26, 2035in 9 yr 1 mo
11234938*PEDMay 26, 2035in 9 yr 1 mo

Ferric oxyhydroxide — 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.

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