FDA Orange Book
Is there a generic for Oriahnn (copackaged)?
Oriahnn (copackaged) contains elagolix sodium estradiol norethindrone acetate and 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 Oriahnn (copackaged) (elagolix sodium estradiol norethindrone acetate and elagolix). The Orange Book shows its last listed patent expires August 27, 2040.
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Oriahnn (copackaged) products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE | Marketed (Rx) | None | 0 | None |
NDA 213388, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Oriahnn (copackaged) patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11459305 | November 7, 2028 | Drug product | U-2842 | 213388 |
| 7419983 | July 6, 2029 | Drug substance, Drug product | None | 213388 |
| 10881659 | March 14, 2034 | Method of use | U-2842 | 213388 |
| 11045470 | March 14, 2034 | Method of use | U-2842 | 213388 |
| 12083227 | August 20, 2038 | Drug product | U-2842 | 213388 |
| 11542239 | July 23, 2039 | Drug substance, Drug product | None | 213388 |
| 11690845 | August 27, 2040 | Method of use | U-3655 | 213388 |
Questions
Is there a generic for Oriahnn (copackaged)?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Oriahnn (copackaged) (elagolix sodium estradiol norethindrone acetate and elagolix). The Orange Book shows its last listed patent expires August 27, 2040.
What is the generic name for Oriahnn (copackaged)?
The active ingredient in Oriahnn (copackaged) is elagolix sodium estradiol norethindrone acetate and elagolix, per the FDA Orange Book.
When does the Oriahnn (copackaged) patent expire?
The last patent listed for Oriahnn (copackaged) 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.