FDA Orange Book
Is there a generic for Orgovyx?
Orgovyx contains relugolix. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Orgovyx (relugolix). The Orange Book shows its last listed patent expires September 29, 2037.
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Orgovyx products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 120MG | Marketed (Rx) | None | 0 | None |
NDA 214621, held by SUMITOMO PHARMA AMERICA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Orgovyx patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8058280 | January 28, 2026 | Drug substance, Drug product | None | 214621 |
| 7300935 | January 28, 2029 | Drug substance | None | 214621 |
| 11795178 | September 27, 2033 | Drug substance, Drug product | None | 214621 |
| 12325714 | September 27, 2033 | Drug substance, Drug product | None | 214621 |
| 10350170 | February 25, 2036 | Drug product | None | 214621 |
| 12144809 | September 29, 2037 | Method of use | U-4035 | 214621 |
| 11583526 | September 29, 2037 | Method of use | U-3020 | 214621 |
| 12336990 | September 29, 2037 | Method of use | U-3020 | 214621 |
| 12097198 | September 29, 2037 | Method of use | U-3020 | 214621 |
| 10449191 | September 29, 2037 | Method of use | U-3020 | 214621 |
| 10786501 | September 29, 2037 | Method of use | U-3020 | 214621 |
| 12629370 | September 29, 2037 | Method of use | U-3020 | 214621 |
Orgovyx NDC codes
Questions
Is there a generic for Orgovyx?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Orgovyx (relugolix). The Orange Book shows its last listed patent expires September 29, 2037.
What is the generic name for Orgovyx?
The active ingredient in Orgovyx is relugolix, per the FDA Orange Book.
When does the Orgovyx patent expire?
The last patent listed for Orgovyx in the Orange Book expires September 29, 2037. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.