FDA Orange Book · active-ingredient family
Relugolix
Relugolix is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:ORGOVYX · NDA 214621
1
Brand (NDA)
0
Generics (ANDA)
12
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ORGOVYXRLD | SUMITOMO PHARMA AM | NDA 214621 | — | Dec 18, 2020 |
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 |
| 12144809 | Sep 29, 2037 | in 11 yr 5 mo | U-4035 |
| 11583526 | Sep 29, 2037 | in 11 yr 5 mo | U-3020 |
| 12336990 | Sep 29, 2037 | in 11 yr 5 mo | U-3020 |
| 12097198 | Sep 29, 2037 | in 11 yr 5 mo | U-3020 |
| 10449191 | Sep 29, 2037 | in 11 yr 5 mo | U-3020 |
| 10786501 | Sep 29, 2037 | in 11 yr 5 mo | U-3020 |
| 12629370 | Sep 29, 2037 | in 11 yr 5 mo | U-3020 |
Relugolix — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
