FDA Orange Book
Is there a generic for Miudella?
Miudella contains copper. 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 Miudella (copper). The Orange Book shows its last listed patent expires January 23, 2037 and its last listed exclusivity ends February 24, 2028.
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Miudella products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| system, intrauterine | N/A | Marketed (Rx) | None | 0 | None |
NDA 218201, held by SEBELA WOMENS HEALTH INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Miudella patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9427351 | August 14, 2032 | Drug product | None | 218201 |
| 11850181 | August 14, 2032 | Drug product | None | 218201 |
| 10188546 | August 14, 2032 | Drug product | None | 218201 |
| 10159596 | August 14, 2032 | Drug product | None | 218201 |
| 9089418 | April 9, 2033 | Drug product | None | 218201 |
| 12138199 | October 18, 2033 | Drug product | None | 218201 |
| 10398588 | February 24, 2034 | Drug product | U-4155 | 218201 |
| 9610191 | February 24, 2034 | Method of use | U-4155 | 218201 |
| 10022264 | March 22, 2034 | Drug product | None | 218201 |
| 9180040 | March 22, 2034 | Drug product | None | 218201 |
| 9265652 | April 28, 2034 | Method of use | U-4155 | 218201 |
| 10166141 | June 13, 2034 | Drug product | None | 218201 |
| 11207209 | August 16, 2034 | Drug product | None | 218201 |
| 10918516 | January 23, 2037 | Drug product | None | 218201 |
Miudella exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | February 24, 2028 | 218201 |
Miudella NDC codes
Questions
Is there a generic for Miudella?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Miudella (copper). The Orange Book shows its last listed patent expires January 23, 2037 and its last listed exclusivity ends February 24, 2028.
What is the generic name for Miudella?
The active ingredient in Miudella is copper, per the FDA Orange Book.
When does the Miudella patent expire?
The last patent listed for Miudella in the Orange Book expires January 23, 2037. 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.