FDA Orange Book · active-ingredient family
Riboflavin 5'-phosphate sodium
Riboflavin 5'-phosphate sodium is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:EPIOXA HD/EPIOXA KIT · NDA 219910
2
Brand (NDA)
0
Generics (ANDA)
0
Listed patents
1
Exclusivity periods
Brand (NDA) products · solution/drops
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EPIOXA HD/EPIOXA KITRLD | GLAUKOS | NDA 219910 | — | Oct 17, 2025 | |
| PHOTREXA VISCOUS IN DEXTRAN 20%/PHOTREXARLD | GLAUKOS | NDA 203324 | — | Apr 15, 2016 |
Marketing exclusivity (1)
- NPNew product exclusivity (3 years)
Oct 17, 2028
in 2 yr 4 mo
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.
Riboflavin 5'-phosphate sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
