FDA Orange Book · active-ingredient family
Temsirolimus
Temsirolimus is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TORISEL · NDA 022088
1
Brand (NDA)
2
Generics (ANDA)
4
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TORISELRLD | PF PRISM CV | NDA 022088 | AP | May 30, 2007 |
Generic (ANDA) products (2)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TEMSIROLIMUS | GLAND | ANDA 207383 | AP | Aug 16, 2019 | |
| TEMSIROLIMUS | ACCORD HLTHCARE | ANDA 203153 | AP | Jul 30, 2018 |
Listed patents (4)
| 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*PED | Nov 10, 2032 | in 6 yr 6 mo |
Temsirolimus — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
