FDA Orange Book
Is there a generic for Mimrylo?
Mimrylo contains rusfertide acetate. 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 Mimrylo (rusfertide acetate). The Orange Book shows its last listed patent expires March 17, 2034 and its last listed exclusivity ends August 28, 2031.
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Mimrylo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, subcutaneous | EQ 19MG BASE/VIAL | Marketed (Rx) | None | 0 | None |
| powder, subcutaneous | EQ 28MG BASE/VIAL | Marketed (Rx) | None | 0 | None |
| powder, subcutaneous | EQ 41MG BASE/VIAL | Marketed (Rx) | None | 0 | None |
| powder, subcutaneous | EQ 54MG BASE/VIAL | Marketed (Rx) | None | 0 | None |
| powder, subcutaneous | EQ 9.5MG BASE/VIAL | Marketed (Rx) | None | 0 | None |
NDA 220605, held by TAKEDA PHARMACEUTICALS AMERICA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Mimrylo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12269856 | March 17, 2034 | Method of use | U-4600 | 220605 |
| 11807674 | March 17, 2034 | Drug product | U-4600 | 220605 |
| 10501515 | March 17, 2034 | Drug substance | U-4600 | 220605 |
| 10442846 | March 17, 2034 | Drug substance, Drug product | U-4600 | 220605 |
| 9822157 | March 17, 2034 | Drug substance, Drug product | None | 220605 |
| 10030061 | March 17, 2034 | Drug substance, Drug product | None | 220605 |
Mimrylo exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | August 28, 2031 | 220605 |
Questions
Is there a generic for Mimrylo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Mimrylo (rusfertide acetate). The Orange Book shows its last listed patent expires March 17, 2034 and its last listed exclusivity ends August 28, 2031.
What is the generic name for Mimrylo?
The active ingredient in Mimrylo is rusfertide acetate, per the FDA Orange Book.
When does the Mimrylo patent expire?
The last patent listed for Mimrylo in the Orange Book expires March 17, 2034. 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.