FDA Orange Book
Is there a generic for Yuviwel?
Yuviwel contains navepegritide. 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 Yuviwel (navepegritide). The Orange Book shows its last listed patent expires November 12, 2042 and its last listed exclusivity ends February 27, 2033.
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Yuviwel products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, subcutaneous | 1.3MG/VIAL | Marketed (Rx) | None | 0 | None |
| powder, subcutaneous | 2.8MG/VIAL | Marketed (Rx) | None | 0 | None |
| powder, subcutaneous | 5.5MG/VIAL | Marketed (Rx) | None | 0 | None |
NDA 219164, held by ASCENDIS PHARMA GROWTH DISORDERS AS. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Yuviwel patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8906847 | April 30, 2031 | Drug substance, Drug product | U-4425 | 219164 |
| 12239689 | January 5, 2037 | Method of use | U-4425 | 219164 |
| 12156917 | January 5, 2037 | Method of use | U-4425 | 219164 |
| 10835578 | January 5, 2037 | Drug substance, Drug product | U-4425 | 219164 |
| 11154593 | January 5, 2037 | Drug substance, Drug product | U-4425 | 219164 |
| 12083182 | January 5, 2037 | Method of use | U-4425 | 219164 |
| 11311604 | January 5, 2037 | Drug substance, Drug product | U-4425 | 219164 |
| 11389511 | January 5, 2037 | Drug product | U-4425 | 219164 |
| 11224661 | January 5, 2037 | Drug substance, Drug product | None | 219164 |
| 11413351 | January 5, 2037 | Drug substance, Drug product | None | 219164 |
| 11389510 | January 5, 2037 | Drug substance, Drug product | None | 219164 |
| 12377133 | November 12, 2042 | Drug product | U-4425 | 219164 |
Yuviwel exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | February 27, 2031 | 219164 |
| ODE-516 | Orphan drug exclusivity | February 27, 2033 | 219164 |
Questions
Is there a generic for Yuviwel?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Yuviwel (navepegritide). The Orange Book shows its last listed patent expires November 12, 2042 and its last listed exclusivity ends February 27, 2033.
What is the generic name for Yuviwel?
The active ingredient in Yuviwel is navepegritide, per the FDA Orange Book.
When does the Yuviwel patent expire?
The last patent listed for Yuviwel in the Orange Book expires November 12, 2042. 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.