Orange Book product · Brand (NDA)
ORGOVYX
RELUGOLIX
At a glance
Dec 18, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
12
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 18, 2020
5 yr 7 mo ago
Patent 8058280 expires
Listed drug substance patent expiration.
Jan 28, 2026
5 mo ago
Today
Patent 7300935 expires
Listed drug substance patent expiration.
Jan 28, 2029
in 2 yr 8 mo
Patent 11795178 expires
Listed drug substance patent expiration.
Sep 27, 2033
in 7 yr 5 mo
Patent 12325714 expires
Listed drug substance patent expiration.
Sep 27, 2033
in 7 yr 5 mo
Patent 10350170 expires
Listed drug product patent expiration.
Feb 25, 2036
in 9 yr 10 mo
Patent 10449191 expires
Listed method-of-use patent (U-3020) expiration.
Sep 29, 2037
in 11 yr 5 mo
Patent 10786501 expires
Listed method-of-use patent (U-3020) expiration.
Sep 29, 2037
in 11 yr 5 mo
Patent 11583526 expires
Listed method-of-use patent (U-3020) expiration.
Sep 29, 2037
in 11 yr 5 mo
Patent 12097198 expires
Listed method-of-use patent (U-3020) expiration.
Sep 29, 2037
in 11 yr 5 mo
Patent 12144809 expires
Listed method-of-use patent (U-4035) expiration.
Sep 29, 2037
in 11 yr 5 mo
Patent 12336990 expires
Listed method-of-use patent (U-3020) expiration.
Sep 29, 2037
in 11 yr 5 mo
Patent 12629370 expires
Listed method-of-use patent (U-3020) expiration.
Sep 29, 2037
in 11 yr 5 mo
Pharmaceutical detail
Active ingredient
RELUGOLIX
Strength
120MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 214621
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 (12)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8058280 | Jan 28, 2026 | 5 mo ago | SubstanceProduct |
| 7300935 | Jan 28, 2029 | in 2 yr 8 mo | Substance |
| 11795178 | Sep 27, 2033 | in 7 yr 5 mo | SubstanceProduct |
| 12325714 | Sep 27, 2033 | in 7 yr 5 mo | SubstanceProduct |
| 10350170 | Feb 25, 2036 | in 9 yr 10 mo | Product |
| 10449191 | Sep 29, 2037 | in 11 yr 5 mo | U-3020 |
| 10786501 | Sep 29, 2037 | in 11 yr 5 mo | U-3020 |
| 11583526 | Sep 29, 2037 | in 11 yr 5 mo | U-3020 |
| 12097198 | Sep 29, 2037 | in 11 yr 5 mo | U-3020 |
| 12144809 | Sep 29, 2037 | in 11 yr 5 mo | U-4035 |
| 12336990 | Sep 29, 2037 | in 11 yr 5 mo | U-3020 |
| 12629370 | Sep 29, 2037 | in 11 yr 5 mo | U-3020 |
