FDA Orange Book
Is there a generic for Annovera?
Annovera contains segesterone acetate and ethinyl estradiol. 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 Annovera (segesterone acetate and ethinyl estradiol). The Orange Book shows its last listed patent expires June 21, 2039.
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Annovera products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| ring, vaginal | 0.013MG/24HR;0.15MG/24HR | Marketed (Rx) | None | 0 | None |
NDA 209627, held by MAYNE PHARMA LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Annovera patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10632066 | February 1, 2039 | Method of use | U-2787 | 209627 |
| 10780047 | February 1, 2039 | Method of use | U-2787 | 209627 |
| 10780047 | February 1, 2039 | Method of use | U-2786 | 209627 |
| 10632066 | February 1, 2039 | Method of use | U-2786 | 209627 |
| 10765628 | February 1, 2039 | Method of use | U-2786 | 209627 |
| 10765628 | February 1, 2039 | Method of use | U-2787 | 209627 |
| 11850251 | June 21, 2039 | Method of use | U-3785 | 209627 |
| 11529308 | June 21, 2039 | Drug product | None | 209627 |
| 10918649 | June 21, 2039 | Drug product | None | 209627 |
| 10925882 | June 21, 2039 | Drug product | None | 209627 |
| 10940157 | June 21, 2039 | Drug product | None | 209627 |
| 12303518 | June 21, 2039 | Drug product | None | 209627 |
Annovera NDC codes
Questions
Is there a generic for Annovera?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Annovera (segesterone acetate and ethinyl estradiol). The Orange Book shows its last listed patent expires June 21, 2039.
What is the generic name for Annovera?
The active ingredient in Annovera is segesterone acetate and ethinyl estradiol, per the FDA Orange Book.
When does the Annovera patent expire?
The last patent listed for Annovera in the Orange Book expires June 21, 2039. 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.