Orange Book product · Brand (NDA)
VELPHORO
FERRIC OXYHYDROXIDE
At a glance
Nov 27, 2013
Approved
Brand (NDA)
Application
Not listed
TE code
22
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 27, 2013
12 yr 9 mo ago
Today
Exclusivity ends · NPP
New patient population exclusivity (3 years)
Jul 01, 2027
in 1 yr 1 mo
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Jan 01, 2028
in 1 yr 7 mo
Patent 10682376 expires
Listed drug product patent expiration.
Nov 13, 2028
in 2 yr 5 mo
Patent 10695367 expires
Listed drug product patent expiration.
Nov 13, 2028
in 2 yr 5 mo
Patent 10925896 expires
Listed drug product patent expiration.
Nov 13, 2028
in 2 yr 5 mo
Patent 10925897 expires
Listed drug product patent expiration.
Nov 13, 2028
in 2 yr 5 mo
Patent 10933090 expires
Listed drug product patent expiration.
Nov 13, 2028
in 2 yr 5 mo
Patent 11013761 expires
Listed drug product patent expiration.
Nov 13, 2028
in 2 yr 5 mo
Patent 11013762 expires
Listed drug product patent expiration.
Nov 13, 2028
in 2 yr 5 mo
Patent 10682376*PED expires
Listed listed patent expiration.
May 13, 2029
in 2 yr 11 mo
Patent 10695367*PED expires
Listed listed patent expiration.
May 13, 2029
in 2 yr 11 mo
Patent 10925896*PED expires
Listed listed patent expiration.
May 13, 2029
in 2 yr 11 mo
Patent 10925897*PED expires
Listed listed patent expiration.
May 13, 2029
in 2 yr 11 mo
Patent 10933090*PED expires
Listed listed patent expiration.
May 13, 2029
in 2 yr 11 mo
Patent 11013761*PED expires
Listed listed patent expiration.
May 13, 2029
in 2 yr 11 mo
Patent 11013762*PED expires
Listed listed patent expiration.
May 13, 2029
in 2 yr 11 mo
Patent 9561251 expires
Listed drug product patent expiration.
Jan 23, 2030
in 3 yr 8 mo
Patent 9561251*PED expires
Listed listed patent expiration.
Jul 23, 2030
in 4 yr 2 mo
Patent 10624855 expires
Listed drug product patent expiration.
Nov 26, 2034
in 8 yr 7 mo
Patent 11234938 expires
Listed drug product patent expiration.
Nov 26, 2034
in 8 yr 7 mo
Patent 11446252 expires
Listed drug product patent expiration.
Nov 26, 2034
in 8 yr 7 mo
Patent 10624855*PED expires
Listed listed patent expiration.
May 26, 2035
in 9 yr 1 mo
Patent 11234938*PED expires
Listed listed patent expiration.
May 26, 2035
in 9 yr 1 mo
Patent 11446252*PED expires
Listed listed patent expiration.
May 26, 2035
in 9 yr 1 mo
Pharmaceutical detail
Active ingredient
FERRIC OXYHYDROXIDE
Strength
EQ 500MG IRON
Dosage form
TABLET, CHEWABLE
Route
ORAL
TE code
Not listed
Application
NDA 205109
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
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)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10682376 | Nov 13, 2028 | in 2 yr 5 mo | Product |
| 10695367 | Nov 13, 2028 | in 2 yr 5 mo | Product |
| 10925896 | Nov 13, 2028 | in 2 yr 5 mo | Product |
| 10925897 | Nov 13, 2028 | in 2 yr 5 mo | Product |
| 10933090 | Nov 13, 2028 | in 2 yr 5 mo | Product |
| 11013761 | Nov 13, 2028 | in 2 yr 5 mo | Product |
| 11013762 | Nov 13, 2028 | in 2 yr 5 mo | Product |
| 10682376*PED | May 13, 2029 | in 2 yr 11 mo | |
| 10695367*PED | May 13, 2029 | in 2 yr 11 mo | |
| 10925896*PED | May 13, 2029 | in 2 yr 11 mo | |
| 10925897*PED | May 13, 2029 | in 2 yr 11 mo | |
| 10933090*PED | May 13, 2029 | in 2 yr 11 mo | |
| 11013761*PED | May 13, 2029 | in 2 yr 11 mo | |
| 11013762*PED | May 13, 2029 | in 2 yr 11 mo | |
| 9561251 | Jan 23, 2030 | in 3 yr 8 mo | ProductU-1468 |
| 9561251*PED | Jul 23, 2030 | in 4 yr 2 mo | |
| 10624855 | Nov 26, 2034 | in 8 yr 7 mo | Product |
| 11234938 | Nov 26, 2034 | in 8 yr 7 mo | Product |
| 11446252 | Nov 26, 2034 | in 8 yr 7 mo | Product |
| 10624855*PED | May 26, 2035 | in 9 yr 1 mo | |
| 11234938*PED | May 26, 2035 | in 9 yr 1 mo | |
| 11446252*PED | May 26, 2035 | in 9 yr 1 mo |
