FDA Orange Book
Is there a generic for Osphena?
Osphena contains ospemifene. 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 Osphena (ospemifene). The Orange Book shows its last listed patent expires July 9, 2028.
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Osphena products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 60MG | Marketed (Rx) | None | 0 | None |
NDA 203505, held by DUCHESNAY INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Osphena patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8236861 | August 11, 2026 | Method of use | U-905 | 203505 |
| 8236861 | August 11, 2026 | Method of use | U-1369 | 203505 |
| 8236861 | August 11, 2026 | Method of use | U-1370 | 203505 |
| 8642079 | July 9, 2028 | Drug product | None | 203505 |
Osphena NDC codes
Questions
Is there a generic for Osphena?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Osphena (ospemifene). The Orange Book shows its last listed patent expires July 9, 2028.
What is the generic name for Osphena?
The active ingredient in Osphena is ospemifene, per the FDA Orange Book.
When does the Osphena patent expire?
The last patent listed for Osphena in the Orange Book expires July 9, 2028. 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.