FDA Orange Book
Is there a generic for Velphoro?
Velphoro contains ferric oxyhydroxide. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Velphoro (ferric oxyhydroxide). The Orange Book shows its last listed patent expires May 26, 2035 and its last listed exclusivity ends January 1, 2028.
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Velphoro products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, chewable, oral | EQ 500MG IRON | Marketed (Rx) | None | 0 | None |
NDA 205109, held by VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA FRANCE. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Velphoro patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10695367 | November 13, 2028 | Drug product | None | 205109 |
| 11013762 | November 13, 2028 | Drug product | None | 205109 |
| 10933090 | November 13, 2028 | Drug product | None | 205109 |
| 10925897 | November 13, 2028 | Drug product | None | 205109 |
| 10682376 | November 13, 2028 | Drug product | None | 205109 |
| 10925896 | November 13, 2028 | Drug product | None | 205109 |
| 11013761 | November 13, 2028 | Drug product | None | 205109 |
| 11013762*PED | May 13, 2029 | Method of use | None | 205109 |
| 10925896*PED | May 13, 2029 | Method of use | None | 205109 |
| 10925897*PED | May 13, 2029 | Method of use | None | 205109 |
| 10933090*PED | May 13, 2029 | Method of use | None | 205109 |
| 10682376*PED | May 13, 2029 | Method of use | None | 205109 |
| 11013761*PED | May 13, 2029 | Method of use | None | 205109 |
| 10695367*PED | May 13, 2029 | Method of use | None | 205109 |
| 9561251 | January 23, 2030 | Drug product | U-1468 | 205109 |
| 9561251*PED | July 23, 2030 | Method of use | None | 205109 |
| 10624855 | November 26, 2034 | Drug product | None | 205109 |
| 11234938 | November 26, 2034 | Drug product | None | 205109 |
| 11446252 | November 26, 2034 | Drug product | None | 205109 |
| 11446252*PED | May 26, 2035 | Method of use | None | 205109 |
| 10624855*PED | May 26, 2035 | Method of use | None | 205109 |
| 11234938*PED | May 26, 2035 | Method of use | None | 205109 |
Velphoro exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NPP | New patient population | July 1, 2027 | 205109 |
| PED | Pediatric exclusivity | January 1, 2028 | 205109 |
Velphoro NDC codes
Questions
Is there a generic for Velphoro?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Velphoro (ferric oxyhydroxide). The Orange Book shows its last listed patent expires May 26, 2035 and its last listed exclusivity ends January 1, 2028.
What is the generic name for Velphoro?
The active ingredient in Velphoro is ferric oxyhydroxide, per the FDA Orange Book.
When does the Velphoro patent expire?
The last patent listed for Velphoro in the Orange Book expires May 26, 2035. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.