FDA Orange Book
Is there a generic for Orilissa?
Orilissa contains elagolix. 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 Orilissa (elagolix). The Orange Book shows its last listed patent expires August 27, 2040.
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Orilissa products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 150MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 200MG BASE | Marketed (Rx) | None | 0 | None |
NDA 210450, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Orilissa patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7419983 | July 6, 2029 | Drug substance, Drug product | U-2360 | 210450 |
| 11707464 | March 14, 2034 | Method of use | U-3672 | 210450 |
| 11344551 | March 14, 2034 | Method of use | U-3388 | 210450 |
| 11344551 | March 14, 2034 | Method of use | U-3389 | 210450 |
| 10537572 | September 1, 2036 | Method of use | U-2735 | 210450 |
| 10682351 | September 1, 2036 | Method of use | U-2850 | 210450 |
| 11690854 | April 19, 2038 | Method of use | U-3653 | 210450 |
| 12102637 | August 20, 2038 | Drug product | None | 210450 |
| 11542239 | July 23, 2039 | Drug substance, Drug product | None | 210450 |
| 11690845 | August 27, 2040 | Method of use | U-3654 | 210450 |
Orilissa NDC codes
Questions
Is there a generic for Orilissa?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Orilissa (elagolix). The Orange Book shows its last listed patent expires August 27, 2040.
What is the generic name for Orilissa?
The active ingredient in Orilissa is elagolix, per the FDA Orange Book.
When does the Orilissa patent expire?
The last patent listed for Orilissa in the Orange Book expires August 27, 2040. 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.