Orange Book product · Brand (NDA)
RAYALDEE
CALCIFEDIOL
At a glance
Jun 17, 2016
Approved
Brand (NDA)
Application
Not listed
TE code
22
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 17, 2016
10 yr 2 mo ago
Today
Patent 10213442 expires
Listed drug product patent expiration.
Feb 02, 2027
in 8 mo
Patent 8906410 expires
Listed drug product patent expiration.
Feb 02, 2027
in 8 mo
Patent 9943530 expires
Listed method-of-use patent (U-2274) expiration.
Feb 02, 2027
in 8 mo
Patent 11154509 expires
Listed method-of-use patent (U-3815) expiration.
Apr 25, 2028
in 1 yr 11 mo
Patent 8207149 expires
Listed method-of-use patent (U-1871) expiration.
Apr 25, 2028
in 1 yr 11 mo
Patent 8778373 expires
Listed method-of-use patent (U-1873) expiration.
Apr 25, 2028
in 1 yr 11 mo
Patent 9408858 expires
Listed method-of-use patent (U-1888) expiration.
Apr 25, 2028
in 1 yr 11 mo
Patent 9498486 expires
Listed method-of-use patent (U-3814) expiration.
Apr 25, 2028
in 1 yr 11 mo
Patent 9925147 expires
Listed drug product patent expiration.
Apr 25, 2028
in 1 yr 11 mo
Patent 9925147 expires
Listed drug product patent expiration.
Apr 25, 2028
in 1 yr 11 mo
Patent 9925147 expires
Listed drug product patent expiration.
Apr 25, 2028
in 1 yr 11 mo
Patent 9925147 expires
Listed drug product patent expiration.
Apr 25, 2028
in 1 yr 11 mo
Patent 9925147 expires
Listed drug product patent expiration.
Apr 25, 2028
in 1 yr 11 mo
Patent 8361488 expires
Listed drug product patent expiration.
Jul 19, 2028
in 2 yr 1 mo
Patent 8426391 expires
Listed method-of-use patent (U-1872) expiration.
Aug 27, 2028
in 2 yr 3 mo
Patent 11801253 expires
Listed drug product patent expiration.
Sep 07, 2030
in 4 yr 3 mo
Patent 11801253 expires
Listed drug product patent expiration.
Sep 07, 2030
in 4 yr 3 mo
Patent 11801253 expires
Listed drug product patent expiration.
Sep 07, 2030
in 4 yr 3 mo
Patent 10300078 expires
Listed drug product patent expiration.
Mar 14, 2034
in 7 yr 10 mo
Patent 10357502 expires
Listed drug product patent expiration.
Mar 14, 2034
in 7 yr 10 mo
Patent 11253528 expires
Listed drug product patent expiration.
Mar 14, 2034
in 7 yr 10 mo
Patent 9861644 expires
Listed drug product patent expiration.
Mar 14, 2034
in 7 yr 10 mo
Pharmaceutical detail
Active ingredient
CALCIFEDIOL
Strength
0.03MG
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 208010
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.
Listed patents (22)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10213442 | Feb 02, 2027 | in 8 mo | Product |
| 8906410 | Feb 02, 2027 | in 8 mo | Product |
| 9943530 | Feb 02, 2027 | in 8 mo | U-2274 |
| 11154509 | Apr 25, 2028 | in 1 yr 11 mo | U-3815 |
| 8207149 | Apr 25, 2028 | in 1 yr 11 mo | U-1871 |
| 8778373 | Apr 25, 2028 | in 1 yr 11 mo | U-1873 |
| 9408858 | Apr 25, 2028 | in 1 yr 11 mo | U-1888 |
| 9498486 | Apr 25, 2028 | in 1 yr 11 mo | U-3814 |
| 9925147 | Apr 25, 2028 | in 1 yr 11 mo | ProductU-2258 |
| 9925147 | Apr 25, 2028 | in 1 yr 11 mo | ProductU-2255 |
| 9925147 | Apr 25, 2028 | in 1 yr 11 mo | ProductU-2256 |
| 9925147 | Apr 25, 2028 | in 1 yr 11 mo | ProductU-2257 |
| 9925147 | Apr 25, 2028 | in 1 yr 11 mo | ProductU-2259 |
| 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 |
| 11801253 | Sep 07, 2030 | in 4 yr 3 mo | ProductU-3722 |
| 11801253 | Sep 07, 2030 | in 4 yr 3 mo | ProductU-3723 |
| 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 |
| 9861644 | Mar 14, 2034 | in 7 yr 10 mo | Product |
