FDA Orange Book
Is there a generic for Yorvipath?
Yorvipath contains palopegteriparatide. 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 Yorvipath (palopegteriparatide). The Orange Book shows its last listed patent expires November 12, 2042 and its last listed exclusivity ends August 9, 2031.
Run it in Rivvi
Map Yorvipath 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.
Yorvipath products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, subcutaneous | EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML) | Marketed (Rx) | None | 0 | None |
NDA 216490, held by ASCENDIS PHARMA BONE DISEASES AS. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Yorvipath patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8906847 | April 30, 2031 | Drug substance, Drug product | U-3982 | 216490 |
| 12453778 | September 28, 2037 | Method of use | U-3982 | 216490 |
| 12295989 | September 28, 2037 | Method of use | U-3982 | 216490 |
| 11857603 | September 28, 2037 | Method of use | U-3982 | 216490 |
| 11590207 | September 28, 2037 | Method of use | U-3982 | 216490 |
| 11890326 | September 28, 2037 | Drug substance, Drug product | None | 216490 |
| 11918628 | September 28, 2037 | Drug substance, Drug product | None | 216490 |
| 11759504 | September 28, 2037 | Drug product | None | 216490 |
| 12403182 | November 12, 2042 | Drug product | U-3982 | 216490 |
Yorvipath exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | August 9, 2029 | 216490 |
| ODE-492 | Orphan drug exclusivity | August 9, 2031 | 216490 |
Yorvipath NDC codes
Questions
Is there a generic for Yorvipath?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Yorvipath (palopegteriparatide). The Orange Book shows its last listed patent expires November 12, 2042 and its last listed exclusivity ends August 9, 2031.
What is the generic name for Yorvipath?
The active ingredient in Yorvipath is palopegteriparatide, per the FDA Orange Book.
When does the Yorvipath patent expire?
The last patent listed for Yorvipath 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.