FDA Orange Book · active-ingredient family
Palopegteriparatide
Palopegteriparatide is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:YORVIPATH · NDA 216490
1
Brand (NDA)
0
Generics (ANDA)
9
Listed patents
6
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| YORVIPATHRLD×3 | ASCENDIS PHARMA BONE | NDA 216490 | — | Aug 09, 2024 |
Marketing exclusivity (6)
- NCENew chemical entity exclusivity (5 years)
Aug 09, 2029
in 3 yr 2 mo
- ODE-492Orphan-drug exclusivity (7 years)
Aug 09, 2031
in 5 yr 3 mo
- NCENew chemical entity exclusivity (5 years)
Aug 09, 2029
in 3 yr 2 mo
- ODE-492Orphan-drug exclusivity (7 years)
Aug 09, 2031
in 5 yr 3 mo
- NCENew chemical entity exclusivity (5 years)
Aug 09, 2029
in 3 yr 2 mo
- ODE-492Orphan-drug exclusivity (7 years)
Aug 09, 2031
in 5 yr 3 mo
Listed patents (9)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8906847 | Apr 30, 2031 | in 4 yr 11 mo | SubstanceProductU-3982 |
| 12453778 | Sep 28, 2037 | in 11 yr 5 mo | U-3982 |
| 12295989 | Sep 28, 2037 | in 11 yr 5 mo | U-3982 |
| 11857603 | Sep 28, 2037 | in 11 yr 5 mo | U-3982 |
| 11590207 | Sep 28, 2037 | in 11 yr 5 mo | U-3982 |
| 11890326 | Sep 28, 2037 | in 11 yr 5 mo | SubstanceProduct |
| 11918628 | Sep 28, 2037 | in 11 yr 5 mo | SubstanceProduct |
| 11759504 | Sep 28, 2037 | in 11 yr 5 mo | Product |
| 12403182 | Nov 12, 2042 | in 16 yr 8 mo | ProductU-3982 |
Palopegteriparatide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
