FDA Orange Book
Is there a generic for Kyleena?
Kyleena contains levonorgestrel. 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 Kyleena (levonorgestrel). The Orange Book shows its last listed patent expires September 16, 2029.
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Kyleena products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| system, intrauterine | 19.5MG | Marketed (Rx) | None | 0 | None |
NDA 208224, held by BAYER HEALTHCARE PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Kyleena patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11628088 | February 7, 2027 | Drug product | None | 208224 |
| 11850182 | September 14, 2029 | Drug product | U-3819 | 208224 |
| 10561524 | September 16, 2029 | Method of use | U-2948 | 208224 |
Kyleena NDC codes
Questions
Is there a generic for Kyleena?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Kyleena (levonorgestrel). The Orange Book shows its last listed patent expires September 16, 2029.
What is the generic name for Kyleena?
The active ingredient in Kyleena is levonorgestrel, per the FDA Orange Book.
When does the Kyleena patent expire?
The last patent listed for Kyleena in the Orange Book expires September 16, 2029. 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.