FDA Orange Book · active-ingredient family
Elagolix sodium
Elagolix sodium is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:ORILISSA · NDA 210450
1
Brand (NDA)
0
Generics (ANDA)
9
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ORILISSARLD×2 | ABBVIE | NDA 210450 | — | Jul 23, 2018 |
Listed patents (9)
| 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 |
| 11344551 | Mar 14, 2034 | in 7 yr 10 mo | U-3388 |
| 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 |
Elagolix sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
