FDA Orange Book
Is there a generic for Fensolvi Kit?
Fensolvi Kit contains leuprolide acetate. 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 Fensolvi Kit (leuprolide acetate). The Orange Book shows its last listed patent expires December 22, 2041.
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Fensolvi Kit products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, subcutaneous | 45MG | Marketed (Rx) | None | 0 | None |
NDA 213150, held by TOLMAR INTERNATIONAL LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Fensolvi Kit patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12397120 | December 22, 2041 | Method of use | U-3611 | 213150 |
| 11931559 | December 22, 2041 | Drug substance | None | 213150 |
| 11771841 | December 22, 2041 | Drug substance, Drug product | None | 213150 |
Fensolvi Kit NDC codes
Questions
Is there a generic for Fensolvi Kit?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Fensolvi Kit (leuprolide acetate). The Orange Book shows its last listed patent expires December 22, 2041.
What is the generic name for Fensolvi Kit?
The active ingredient in Fensolvi Kit is leuprolide acetate, per the FDA Orange Book.
When does the Fensolvi Kit patent expire?
The last patent listed for Fensolvi Kit in the Orange Book expires December 22, 2041. 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.