Orange Book product · Brand (NDA)
TORISEL
TEMSIROLIMUS
At a glance
May 30, 2007
Approved
Brand (NDA)
Application
AP
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 30, 2007
19 yr 4 mo ago
Patent 8026276 expires
Listed drug product patent expiration.
Jan 20, 2026
5 mo ago
Today
Patent 8026276*PED expires
Listed listed patent expiration.
Jul 20, 2026
in 1 mo
Patent 8791097 expires
Listed method-of-use patent (U-1551) expiration.
May 10, 2032
in 6 yr
Patent 8791097 expires
Listed method-of-use patent (U-1550) expiration.
May 10, 2032
in 6 yr
Patent 8791097*PED expires
Listed listed patent expiration.
Nov 10, 2032
in 6 yr 6 mo
Pharmaceutical detail
Active ingredient
TEMSIROLIMUS
Strength
25MG/ML (25MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP
Application
NDA 022088
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.
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8026276 | Jan 20, 2026 | 5 mo ago | Product |
| 8026276*PED | Jul 20, 2026 | in 1 mo | |
| 8791097 | May 10, 2032 | in 6 yr | U-1551 |
| 8791097 | May 10, 2032 | in 6 yr | U-1550 |
| 8791097*PED | Nov 10, 2032 | in 6 yr 6 mo |
