Orange Book product · Brand (NDA)
ORIAHNN (COPACKAGED)
ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM
At a glance
May 29, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
7
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 29, 2020
6 yr 2 mo ago
Today
Patent 11459305 expires
Listed drug product patent expiration.
Nov 07, 2028
in 2 yr 5 mo
Patent 7419983 expires
Listed drug substance patent expiration.
Jul 06, 2029
in 3 yr 1 mo
Patent 10881659 expires
Listed method-of-use patent (U-2842) expiration.
Mar 14, 2034
in 7 yr 10 mo
Patent 11045470 expires
Listed method-of-use patent (U-2842) expiration.
Mar 14, 2034
in 7 yr 10 mo
Patent 12083227 expires
Listed drug product patent expiration.
Aug 20, 2038
in 12 yr 4 mo
Patent 11542239 expires
Listed drug substance patent expiration.
Jul 23, 2039
in 13 yr 3 mo
Patent 11690845 expires
Listed method-of-use patent (U-3655) expiration.
Aug 27, 2040
in 14 yr 5 mo
Pharmaceutical detail
Active ingredient
ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM
Strength
EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 213388
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 (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11459305 | Nov 07, 2028 | in 2 yr 5 mo | ProductU-2842 |
| 7419983 | Jul 06, 2029 | in 3 yr 1 mo | SubstanceProduct |
| 10881659 | Mar 14, 2034 | in 7 yr 10 mo | U-2842 |
| 11045470 | Mar 14, 2034 | in 7 yr 10 mo | U-2842 |
| 12083227 | Aug 20, 2038 | in 12 yr 4 mo | ProductU-2842 |
| 11542239 | Jul 23, 2039 | in 13 yr 3 mo | SubstanceProduct |
| 11690845 | Aug 27, 2040 | in 14 yr 5 mo | U-3655 |
