Orange Book product · Brand (NDA)
QALSODY
TOFERSEN
At a glance
Apr 25, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
3
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 25, 2023
3 yr 2 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Apr 25, 2028
in 1 yr 11 mo
Exclusivity ends · ODE-432
Orphan-drug exclusivity (7 years)
Apr 25, 2030
in 3 yr 11 mo
Patent 10385341 expires
Listed drug substance patent expiration.
Apr 01, 2035
in 8 yr 11 mo
Patent 10669546 expires
Listed method-of-use patent (U-3575) expiration.
Apr 01, 2035
in 8 yr 11 mo
Patent 10968453 expires
Listed method-of-use patent (U-3575) expiration.
Apr 01, 2035
in 8 yr 11 mo
Pharmaceutical detail
Active ingredient
TOFERSEN
Strength
100MG/15ML (6.7MG/ML)
Dosage form
SOLUTION
Route
INTRATHECAL
TE code
Not listed
Application
NDA 215887
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)
Apr 25, 2028
in 1 yr 11 mo
- ODE-432Orphan-drug exclusivity (7 years)
Apr 25, 2030
in 3 yr 11 mo
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10385341 | Apr 01, 2035 | in 8 yr 11 mo | SubstanceProduct |
| 10669546 | Apr 01, 2035 | in 8 yr 11 mo | U-3575 |
| 10968453 | Apr 01, 2035 | in 8 yr 11 mo | U-3575 |
