Generic Torisel Availability

Torisel is a brand name of temsirolimus, approved by the FDA in the following formulation(s):

TORISEL (temsirolimus - solution;intravenous)

  • Manufacturer: PF PRISM CV
    Approval date: May 30, 2007
    Strength(s): 25MG/ML (25MG/ML) [RLD]

Has a generic version of Torisel been approved?

No. There is currently no therapeutically equivalent version of Torisel available in the United States.

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: About generic drugs.

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.

  • Rapamycin hydroxyesters
    Patent 5,362,718
    Issued: November 8, 1994
    Inventor(s): Skotnicki; Jerauld S. & Leone; Christina L. & Schiehser; Guy A.
    Assignee(s): American Home Products Corporation
    A compound of the structure ##STR1## wherein R.sup.1 and R.sup.2 are each, independently, hydrogen or --CO(CR.sup.3 R.sup.4).sub.b (CR.sup.5 R.sup.6).sub.d CR.sup.7 R.sup.8 R.sup.9 ; R.sup.3 and R.sup.4 are each, independently, hydrogen, alkyl, alkenyl, alkynyl, trifluoromethyl, or --F; R.sup.5 and R.sup.6 are each, independently, hydrogen, alkyl, alkenyl, alkynyl, --(CR.sup.3 R.sup.4).sub.f OR.sup.10, --CF.sub.3, --F, or --CO.sub.2 R.sup.11, or R.sup.5 and R.sup.6 may be taken together to form X or a cycloalkyl ring that is optionally mono-, di-, or tri-substituted with --(CR.sup.3 R.sup.4).sub.f 0R.sup.10 ; R.sup.7 is hydrogen, alkyl, alkenyl, alkynyl, --(CR.sup.3 R.sup.4).sub.f OR.sup.10, --CF.sub.3, --F, or --CO.sub.2 R.sup.11 ; R.sup.8 and R.sup.9 are each, independently, hydrogen, alkyl, alkenyl, alkynyl, --(CR.sup.3 R.sup.4).sub.f OR.sup.10, --CF.sub.3, --F, or --CO.sub.2 R.sup.11, or R.sup.8 and R.sup.9 may be taken together to form X or a cycloalkyl ring that is optionally mono-, di-, or tri-substituted with --(CR.sup.3 R.sup.4).sub.f OR.sup.10 ; R.sup.10 is hydrogen, alkyl, alkenyl, alkynyl, tri-(alkyl)silyl, tri-(alkyl)silylethyl, triphenylmethyl, benzyl, alkoxymethyl, tri-(alkyl)silylethoxymethyl, chloroethyl, or tetrahydropyranyl; R.sup.11 is hydrogen, alkyl, alkenyl, alkynyl, or phenylalkyl; X is 5-(2,2-dialkyl)[1,3]dioxanyl, 5-(2,2-dicycloalkyl)[1,3]dioxanyl, 4-(2,2-dialkyl)[1,3]dioxanyl, 4-(2,2-dicycloalkyl)[1,3]dioxanyl, 4-(2,2dialkyl)[1,3]dioxalanyl, or 4-(2,2-dicycloalkyl)[1,3]dioxalanyl; b=0-6; d=0-6; and f=0-6 with the proviso that R.sup.1 and R.sup.2 are both not hydrogen and further provided that either R.sup.1 or R.sup.2 contains at least one --(CR.sup.3 R.sup.4).sub.f OR.sup.10, X, or --(CR.sup.3 R.sup.4).sub.f OR.sup.10 substituted cycloalkyl group, or a pharmaceutically acceptable salt thereof which is useful as an immunosuppressive, antiinflammatory, antifungal, antiproliferative, and antitumor agent.
    Patent expiration dates:
    • February 15, 2019
      ✓ 
      Drug substance
      ✓ 
      Drug product
      ✓ 
      Sponsor has requested patent be delisted
    • August 15, 2019
      ✓ 
      Pediatric exclusivity
  • Parenteral CCI-779 formulations containing cosolvents, an antioxidant, and a surfactant
    Patent 8,026,276
    Issued: September 27, 2011
    Inventor(s): Rubino; Joseph T. & Siskavich; Victoria & Harrison; Maureen M. & Gandhi; Pooja
    Assignee(s): Wyeth LLC
    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
      ✓ 
      Drug product
    • July 20, 2026
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      Pediatric exclusivity
  • CCI-779 concentrate formulations
    Patent 8,299,116
    Issued: October 30, 2012
    Inventor(s): Rubino; Joseph T & Siskavich; Victoria & Harrison; Maureen M & Gandhi; Pooja
    Assignee(s): Wyeth LLC
    This invention provides CCI-779 cosolvent concentrates which are useful in preparing a parenteral formulation of rapamycin 42-ester with 3-hydroxy-2-(hydroxymethyl)-2-methylpropionic acid (CCI-779) following admixture with a diluent.
    Patent expiration dates:
    • July 25, 2023
      ✓ 
      Drug product
    • January 25, 2024
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      Pediatric exclusivity
  • CCI-779 concentrate formulations
    Patent 8,455,539
    Issued: June 4, 2013
    Assignee(s): Wyeth LLC
    This invention provides CCI-779 cosolvent concentrates which are useful in preparing a parenteral formulation of rapamycin 42-ester with 3-hydroxy-2-(hydroxymethyl)-2-methylpropionic acid (CCI-779) following admixture with a diluent.
    Patent expiration dates:
    • July 25, 2023
      ✓ 
      Drug product
    • January 25, 2024
      ✓ 
      Pediatric exclusivity
  • CCI-779 formulations for parenteral administration
    Patent 8,722,700
    Issued: May 13, 2014
    Assignee(s): Wyeth LLC
    This invention provides CCI-779 cosolvent concentrates which are useful in preparing a parenteral formulation of rapamycin 42-ester with 3-hydroxy-2-(hydroxymethyl)-2-methylpropionic acid (CCI-779) following admixture with a diluent.
    Patent expiration dates:
    • July 25, 2023
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      Drug product
    • January 25, 2024
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      Pediatric exclusivity
  • Rapamycin hydroxyesters
    Patent RE44768
    Issued: February 18, 2014
    Assignee(s): Wyeth LLC
    A compound of the structure wherein R1 and R2 are each, independently, hydrogen or —CO(CR3R4)b(CR5R6)dCR7R8R9; R3 and R4 are each, independently, hydrogen, alkyl, alkenyl, alkynyl, trifluoromethyl, or —F; R5 and R6 are each, independently, hydrogen, alkyl, alkenyl, alkynyl, —(CR3R4)fOR10, —CF3, —F, or —CO2R11, or R5 and R6 may be taken together to form X or a cycloalkyl ring that is optionally mono-, di-, or tri-substituted with —(CR3R4)fOR10; R7 is hydrogen, alkyl, alkenyl, alkynyl, —(CR3R4-)fOR10, —CF3, —F, or CO2R11; R8 and R9 are each, independently, hydrogen, alkyl, alkenyl, alkynyl, —(CR3R4)fOR10, —CF3, —F, or —CO2R11, or R8 and R9 may be taken together to form X or a cycloalkyl ring that is optionally mono-, di-, or tri-substituted with —(CR3R4-)fOR10; R10 is hydrogen, alkyl, alkenyl, alkynyl, tri-(alkyl)silyl, tri-(alkyl)silylethyl, triphenylmethyl, benzyl, alkoxymethyl, tri-(alkyl)silylethoxymethyl, chloroethyl, or tetrahydropyranyl; R11 is hydrogen, alkyl, alkenyl, alkynyl, or phenylalkyl; X is 5-(2,2-dialkyl)[1,3]dioxanyl, 5-(2,2-dicycloalkyl)[1,3]dioxanyl, 4-(2,2-dialkyl)[1,3]dioxanyl, 4-(2,2-dicycloalkyl)[1,3]dioxanyl, 4-(2,2dialkyl)[1,3]dioxalanyl, or 4-(2,2-dicycloalkyl)[1,3]dioxalanyl; b=0-6; d=0-6; and f=0-6 with the proviso that R1 and R2 are both not hydrogen and further provided that either R1 or R2 contains at least one —(CR3R4)fOR10, X, or —(CR3R4)fOR10 substituted cycloalkyl group, or a pharmaceutically acceptable salt thereof which is useful as an immunosuppressive, antiinflammatory, antifungal, antiproliferative, and antitumor agent.
    Patent expiration dates:
    • February 15, 2019
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • August 15, 2019
      ✓ 
      Pediatric exclusivity

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • July 9, 2013 - UPDATES TO THE PACKAGE INSERT BASED UPON THE TRIAL ENTITLED 'A PHASE I PHARMACOKINETIC AND PHARMACODYNAMIC STUDY OF TEMSIROLIMUS IN PATIENTS WITH ADVANCED MALIGNANCIES AND NORMAL AND IMPAIRED LIVER FUNCTION
    • October 26, 2013 -
    • January 9, 2014 -
    • May 30, 2014 -
    • November 30, 2014 -
    • May 30, 2015 - REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
    • November 30, 2015 -

Glossary

TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
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