FDA Orange Book · active-ingredient family
Calcifediol
Calcifediol is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:RAYALDEE · NDA 208010
2
Brand (NDA)
0
Generics (ANDA)
16
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, capsule, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| RAYALDEERLD | EIRGEN | NDA 208010 | — | Jun 17, 2016 | |
| CALDEROL×2 | ORGANON USA INC | NDA 018312 | — | Approved Prior to Jan 1, 1982 |
Listed patents (16)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9943530 | Feb 02, 2027 | in 8 mo | U-2274 |
| 10213442 | Feb 02, 2027 | in 8 mo | Product |
| 8906410 | Feb 02, 2027 | in 8 mo | Product |
| 8778373 | Apr 25, 2028 | in 1 yr 11 mo | U-1873 |
| 9408858 | Apr 25, 2028 | in 1 yr 11 mo | U-1888 |
| 9925147 | Apr 25, 2028 | in 1 yr 11 mo | ProductU-2258 |
| 8207149 | Apr 25, 2028 | in 1 yr 11 mo | U-1871 |
| 9498486 | Apr 25, 2028 | in 1 yr 11 mo | U-3814 |
| 11154509 | Apr 25, 2028 | in 1 yr 11 mo | U-3815 |
| 8361488 | Jul 19, 2028 | in 2 yr 1 mo | Product |
| 8426391 | Aug 27, 2028 | in 2 yr 3 mo | U-1872 |
| 11801253 | Sep 07, 2030 | in 4 yr 3 mo | ProductU-3721 |
| 9861644 | Mar 14, 2034 | in 7 yr 10 mo | Product |
| 10300078 | Mar 14, 2034 | in 7 yr 10 mo | Product |
| 10357502 | Mar 14, 2034 | in 7 yr 10 mo | Product |
| 11253528 | Mar 14, 2034 | in 7 yr 10 mo | Product |
Calcifediol — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
