FDA Orange Book
Is there a generic for Mirena?
Mirena 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 Mirena (levonorgestrel). The Orange Book shows its last listed patent expires September 16, 2029.
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Mirena 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 021225, 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.
Mirena patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11850182 | September 14, 2029 | Drug product | U-3819 | 021225 |
| 10561524 | September 16, 2029 | Method of use | U-2948 | 021225 |
Mirena NDC codes
Questions
Is there a generic for Mirena?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Mirena (levonorgestrel). The Orange Book shows its last listed patent expires September 16, 2029.
What is the generic name for Mirena?
The active ingredient in Mirena is levonorgestrel, per the FDA Orange Book.
When does the Mirena patent expire?
The last patent listed for Mirena 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.