FDA Orange Book
Is there a generic for Nextstellis?
Nextstellis contains drospirenone and estetrol. 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 Nextstellis (drospirenone and estetrol). The Orange Book shows its last listed patent expires October 1, 2043 and its last listed exclusivity ends April 15, 2026.
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Nextstellis products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 3MG;14.2MG | Marketed (Rx) | None | 0 | None |
NDA 214154, 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.
Nextstellis patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7732430 | January 15, 2028 | Drug product | U-3152 | 214154 |
| 12427114 | June 17, 2036 | Drug product | U-3152 | 214154 |
| 11957694 | June 17, 2036 | Drug product | None | 214154 |
| 11793760 | June 17, 2036 | Drug product | None | 214154 |
| 11964055 | June 17, 2036 | Drug product | None | 214154 |
| 12233074 | February 9, 2043 | Drug product | U-3152 | 214154 |
| 12458649 | October 1, 2043 | Method of use | U-3152 | 214154 |
Nextstellis exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | April 15, 2026 | 214154 |
Questions
Is there a generic for Nextstellis?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Nextstellis (drospirenone and estetrol). The Orange Book shows its last listed patent expires October 1, 2043 and its last listed exclusivity ends April 15, 2026.
What is the generic name for Nextstellis?
The active ingredient in Nextstellis is drospirenone and estetrol, per the FDA Orange Book.
When does the Nextstellis patent expire?
The last patent listed for Nextstellis in the Orange Book expires October 1, 2043. 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.