Orange Book product · Brand (NDA)
YORVIPATH
PALOPEGTERIPARATIDE
At a glance
Aug 09, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
9
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 09, 2024
1 yr 11 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Aug 09, 2029
in 3 yr 2 mo
Patent 8906847 expires
Listed drug substance patent expiration.
Apr 30, 2031
in 4 yr 11 mo
Exclusivity ends · ODE-492
Orphan-drug exclusivity (7 years)
Aug 09, 2031
in 5 yr 3 mo
Patent 11590207 expires
Listed method-of-use patent (U-3982) expiration.
Sep 28, 2037
in 11 yr 5 mo
Patent 11759504 expires
Listed drug product patent expiration.
Sep 28, 2037
in 11 yr 5 mo
Patent 11857603 expires
Listed method-of-use patent (U-3982) expiration.
Sep 28, 2037
in 11 yr 5 mo
Patent 11890326 expires
Listed drug substance patent expiration.
Sep 28, 2037
in 11 yr 5 mo
Patent 11918628 expires
Listed drug substance patent expiration.
Sep 28, 2037
in 11 yr 5 mo
Patent 12295989 expires
Listed method-of-use patent (U-3982) expiration.
Sep 28, 2037
in 11 yr 5 mo
Patent 12453778 expires
Listed method-of-use patent (U-3982) expiration.
Sep 28, 2037
in 11 yr 5 mo
Patent 12403182 expires
Listed drug product patent expiration.
Nov 12, 2042
in 16 yr 8 mo
Pharmaceutical detail
Active ingredient
PALOPEGTERIPARATIDE
Strength
EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML)
Dosage form
SOLUTION
Route
SUBCUTANEOUS
TE code
Not listed
Application
NDA 216490
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (2)
- 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 |
| 11590207 | Sep 28, 2037 | in 11 yr 5 mo | U-3982 |
| 11759504 | Sep 28, 2037 | in 11 yr 5 mo | Product |
| 11857603 | 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 |
| 12295989 | Sep 28, 2037 | in 11 yr 5 mo | U-3982 |
| 12453778 | Sep 28, 2037 | in 11 yr 5 mo | U-3982 |
| 12403182 | Nov 12, 2042 | in 16 yr 8 mo | ProductU-3982 |
