Orange Book product · Brand (NDA)
ORILISSA
ELAGOLIX SODIUM
At a glance
Jul 23, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
8
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 23, 2018
8 yr ago
Today
Patent 7419983 expires
Listed drug substance patent expiration.
Jul 06, 2029
in 3 yr 1 mo
Patent 11707464 expires
Listed method-of-use patent (U-3672) expiration.
Mar 14, 2034
in 7 yr 10 mo
Patent 10537572 expires
Listed method-of-use patent (U-2735) expiration.
Sep 01, 2036
in 10 yr 4 mo
Patent 10682351 expires
Listed method-of-use patent (U-2850) expiration.
Sep 01, 2036
in 10 yr 4 mo
Patent 11690854 expires
Listed method-of-use patent (U-3653) expiration.
Apr 19, 2038
in 12 yr
Patent 12102637 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-3654) expiration.
Aug 27, 2040
in 14 yr 5 mo
Pharmaceutical detail
Active ingredient
ELAGOLIX SODIUM
Strength
EQ 150MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 210450
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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 (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7419983 | Jul 06, 2029 | in 3 yr 1 mo | SubstanceProductU-2360 |
| 11707464 | Mar 14, 2034 | in 7 yr 10 mo | U-3672 |
| 10537572 | Sep 01, 2036 | in 10 yr 4 mo | U-2735 |
| 10682351 | Sep 01, 2036 | in 10 yr 4 mo | U-2850 |
| 11690854 | Apr 19, 2038 | in 12 yr | U-3653 |
| 12102637 | Aug 20, 2038 | in 12 yr 4 mo | Product |
| 11542239 | Jul 23, 2039 | in 13 yr 3 mo | SubstanceProduct |
| 11690845 | Aug 27, 2040 | in 14 yr 5 mo | U-3654 |
