Orange Book product · Brand (NDA)
TRYNGOLZA (AUTOINJECTOR)
OLEZARSEN SODIUM
At a glance
Dec 19, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 19, 2024
1 yr 6 mo ago
Today
Exclusivity ends · ODE-515
Orphan-drug exclusivity (7 years)
Dec 19, 2031
in 5 yr 7 mo
Patent 9157082 expires
Listed method-of-use patent (U-4050) expiration.
Apr 27, 2032
in 5 yr 11 mo
Patent 9593333 expires
Listed method-of-use patent (U-4050) expiration.
Feb 14, 2034
in 7 yr 9 mo
Patent 12509684 expires
Listed method-of-use patent (U-4050) expiration.
May 01, 2034
in 8 yr
Patent 9127276 expires
Listed drug substance patent expiration.
May 01, 2034
in 8 yr
Patent 9163239 expires
Listed drug substance patent expiration.
May 01, 2034
in 8 yr
Patent 9181549 expires
Listed drug substance patent expiration.
May 01, 2034
in 8 yr
Pharmaceutical detail
Active ingredient
OLEZARSEN SODIUM
Strength
EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)
Dosage form
SOLUTION
Route
SUBCUTANEOUS
TE code
Not listed
Application
NDA 218614
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 (1)
- ODE-515Orphan-drug exclusivity (7 years)
Dec 19, 2031
in 5 yr 7 mo
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9157082 | Apr 27, 2032 | in 5 yr 11 mo | U-4050 |
| 9593333 | Feb 14, 2034 | in 7 yr 9 mo | U-4050 |
| 12509684 | May 01, 2034 | in 8 yr | U-4050 |
| 9127276 | May 01, 2034 | in 8 yr | Substance |
| 9163239 | May 01, 2034 | in 8 yr | Substance |
| 9181549 | May 01, 2034 | in 8 yr | Substance |
