FDA Orange Book
Is there a generic for Liletta?
Liletta 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 Liletta (levonorgestrel). The Orange Book shows its last listed patent expires September 7, 2040 and its last listed exclusivity ends June 29, 2026.
Run it in Rivvi
Map Liletta and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Liletta products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| system, intrauterine | 52MG | Marketed (Rx) | None | 0 | None |
NDA 206229, held by MEDICINES360. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Liletta patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12004992 | October 6, 2033 | Drug substance | None | 206229 |
| 11090186 | October 24, 2033 | Method of use | U-2348 | 206229 |
| 10028858 | March 22, 2034 | Drug product | U-2348 | 206229 |
| 11571328 | September 7, 2040 | Drug product | None | 206229 |
Liletta exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-917 | New indication | June 29, 2026 | 206229 |
Liletta NDC codes
Questions
Is there a generic for Liletta?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Liletta (levonorgestrel). The Orange Book shows its last listed patent expires September 7, 2040 and its last listed exclusivity ends June 29, 2026.
What is the generic name for Liletta?
The active ingredient in Liletta is levonorgestrel, per the FDA Orange Book.
When does the Liletta patent expire?
The last patent listed for Liletta in the Orange Book expires September 7, 2040. 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.