FDA Orange Book
Is there a generic for Skyla?
Skyla 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 Skyla (levonorgestrel). The Orange Book shows its last listed patent expires September 16, 2029.
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Skyla products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| system, intrauterine | 13.5MG | Marketed (Rx) | None | 0 | None |
NDA 203159, 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.
Skyla patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11628088 | February 7, 2027 | Drug product | None | 203159 |
| 11850182 | September 14, 2029 | Drug product | U-3819 | 203159 |
| 10561524 | September 16, 2029 | Method of use | U-2948 | 203159 |
Skyla NDC codes
Questions
Is there a generic for Skyla?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Skyla (levonorgestrel). The Orange Book shows its last listed patent expires September 16, 2029.
What is the generic name for Skyla?
The active ingredient in Skyla is levonorgestrel, per the FDA Orange Book.
When does the Skyla patent expire?
The last patent listed for Skyla 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.