FDA Orange Book
Generic for Torisel
Torisel contains temsirolimus. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Torisel is temsirolimus. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Torisel products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 25MG/ML (25MG/ML) | Marketed (Rx) | AP | 2 | AP |
NDA 022088, held by PF PRISM CV. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic temsirolimus
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACCORD HEALTHCARE INC | 203153 | AP (A-rated, therapeutically equivalent) | July 30, 2018 | 25MG/ML (25MG/ML) |
| GLAND PHARMA LTD | 207383 | AP (A-rated, therapeutically equivalent) | August 16, 2019 | 25MG/ML (25MG/ML) |
Torisel patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8026276 | January 20, 2026 | Drug product | None | 022088 |
| 8026276*PED | July 20, 2026 | Method of use | None | 022088 |
| 8791097 | May 10, 2032 | Method of use | U-1551 | 022088 |
| 8791097 | May 10, 2032 | Method of use | U-1550 | 022088 |
| 8791097*PED | November 10, 2032 | Method of use | None | 022088 |
Questions
Is there a generic for Torisel?
Yes. The generic name for Torisel is temsirolimus. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Torisel?
The active ingredient in Torisel is temsirolimus, per the FDA Orange Book.
When does the Torisel patent expire?
The last patent listed for Torisel in the Orange Book expires November 10, 2032. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.