Torisel is a brand name of temsirolimus, approved by the FDA in the following formulation(s):
TORISEL (temsirolimus - solution; intravenous)
Manufacturer: WYETH PHARMS INC
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.
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:
- April 18, 2014✓✓
- April 18, 2014
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✓
- January 20, 2026
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:
- May 30, 2012 - NEW CHEMICAL ENTITY
- April 26, 2013 - UPDATED LABELING BASED UPON STUDY: A SINGLE-DOSE, SINGLE-BLIND, PLACEBO-AND MOXIFLOXACIN-CONTROLLED 2-PERIOD, RANDOMIZED, CROSSOVER, 3RD PERIOD SEQUENTIAL STUDY OF SIDE EFFECTS OF TEMSIROLIMUS ON CARDIAC REPOLARIZATION IN HEALTHY SUBJECTS
- 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
- May 30, 2014 - ORPHAN DRUG EXCLUSIVITY
See also...
- Torisel Consumer Information (Drugs.com)
- Torisel Consumer Information (Wolters Kluwer)
- Torisel Consumer Information (Cerner Multum)
- Torisel Advanced Consumer Information (Micromedex)
- Torisel AHFS DI Monographs (ASHP)
- Temsirolimus Consumer Information (Wolters Kluwer)
- Temsirolimus Consumer Information (Cerner Multum)
- Temsirolimus Intravenous Advanced Consumer Information (Micromedex)
- Temsirolimus AHFS DI Monographs (ASHP)
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