palopegteriparatide · Ascendis Pharma Bone · NDA 216490
Yorvipath
Earliest generic entry, as listed · earliest of 3 marketed strengths
12 Nov 2042
Blocked by patent: US 12403182.
Listed patents · 9 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12403182 | drug product, use U-3982 · sets the listed date | 12 Nov 2042 |
| US 11590207 | use U-3982 | 28 Sep 2037 |
| US 11759504 | drug product | 28 Sep 2037 |
| US 11857603 | use U-3982 | 28 Sep 2037 |
| US 11890326 | drug substance, drug product | 28 Sep 2037 |
| US 11918628 | drug substance, drug product | 28 Sep 2037 |
| US 12295989 | use U-3982 | 28 Sep 2037 |
| US 12453778 | use U-3982 | 28 Sep 2037 |
| US 8906847 | drug substance, drug product, use U-3982 | 30 Apr 2031 |
Exclusivities · 2 unexpired
| ODE-492 | orphan drug (7 years) | 9 Aug 2031 |
| NCE | new chemical entity (5 years) | 9 Aug 2029 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 216490 · 001 · RLD | solution, subcutaneous | EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML) | 12 Nov 2042 |
| 216490 · 002 · RLD | solution, subcutaneous | EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML) | 12 Nov 2042 |
| 216490 · 003 · RLD | solution, subcutaneous | EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML) | 12 Nov 2042 |