Generic Torisel Availability
Last updated on Apr 10, 2025.
Torisel is a brand name of temsirolimus, approved by the FDA in the following formulation(s):
TORISEL (temsirolimus - solution;intravenous)
Is there a generic version of Torisel available?
A generic version of Torisel has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Torisel and have been approved by the FDA:
temsirolimus solution;intravenous
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Manufacturer: ACCORD HLTHCARE
Approval date: July 30, 2018
Strength(s): 25MG/ML (25MG/ML) [AP] -
Manufacturer: GLAND
Approval date: August 16, 2019
Strength(s): 25MG/ML (25MG/ML) [AP]
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Torisel. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Parenteral CCI-779 formulations containing cosolvents, an antioxidant, and a surfactant
Patent 8,026,276
Issued: September 27, 2011
Inventor(s): Rubino; Joseph T. et al.
Assignee(s): Wyeth LLC (Madison, NJ)Parenteral formulations of rapamycin 42-ester with 3-hydroxy-2-(hydroxymethyl) -2-methylpropionic acid (CCI-779) are provided. One parenteral formulation contains CCI-779, an alcoholic co-solvent, and an antioxidant. Another parenteral formulation contains CCI-779, an alcoholic solvent, an antioxidant, a diluent solvent, and a surfactant. Processes for preparing parenteral CCI-779 formulations using a co-solvent concentrate are also provided.
Patent expiration dates:
- January 20, 2026✓
- January 20, 2026
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Parenteral CCI-779 formulations containing cosolvents, an antioxidant, and a surfactant
Patent 8026276*PED
Issued: September 27, 2011
Inventor(s): Rubino; Joseph T. et al.
Assignee(s): Wyeth LLC (Madison, NJ)Parenteral formulations of rapamycin 42-ester with 3-hydroxy-2-(hydroxymethyl) -2-methylpropionic acid (CCI-779) are provided. One parenteral formulation contains CCI-779, an alcoholic co-solvent, and an antioxidant. Another parenteral formulation contains CCI-779, an alcoholic solvent, an antioxidant, a diluent solvent, and a surfactant. Processes for preparing parenteral CCI-779 formulations using a co-solvent concentrate are also provided.
Patent expiration dates:
- July 20, 2026✓
- July 20, 2026
-
Anti-tumor activity of CCI-779 in papillary renal cell cancer
Patent 8,791,097
Issued: July 29, 2014
Inventor(s): Dukart Gary & Gibbons & Jr. James Joseph & Berkenblit Anna & Feingold Jay Marshall
Assignee(s): Wyeth LLCThis invention provides the method or use of CCI-779 in the treatment of papillary renal cell carcinoma.
Patent expiration dates:
- May 10, 2032✓
- May 10, 2032✓
- May 10, 2032
-
Anti-tumor activity of CCI-779 in papillary renal cell cancer
Patent 8791097*PED
Issued: July 29, 2014
Inventor(s): Dukart Gary & Gibbons & Jr. James Joseph & Berkenblit Anna & Feingold Jay Marshall
Assignee(s): Wyeth LLCThis invention provides the method or use of CCI-779 in the treatment of papillary renal cell carcinoma.
Patent expiration dates:
- November 10, 2032✓
- November 10, 2032
More about Torisel (temsirolimus)
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- During pregnancy
- FDA approval history
- Drug class: mTOR inhibitors
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Glossary
Term | Definition |
---|---|
Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
AP | Injectable aqueous solutions and, in certain instances, intravenous non-aqueous solutions. It should be noted that even though injectable (parenteral) products under a specific listing may be evaluated as therapeutically equivalent, there may be important differences among the products in the general category, Injectable; Injection. For example, some injectable products that are rated therapeutically equivalent are labeled for different routes of administration. In addition, some products evaluated as therapeutically equivalent may have different preservatives or no preservatives at all. Injectable products available as dry powders for reconstitution, concentrated sterile solutions for dilution, or sterile solutions ready for injection are pharmaceutical alternative drug products. They are not rated as therapeutically equivalent (AP) to each other even if these pharmaceutical alternative drug products are designed to produce the same concentration prior to injection and are similarly labeled. Consistent with accepted professional practice, it is the responsibility of the prescriber, dispenser, or individual administering the product to be familiar with a product's labeling to assure that it is given only by the route(s) of administration stated in the labeling. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.