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Last Updated: February 19, 2020

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TORISEL Drug Profile


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When do Torisel patents expire, and what generic alternatives are available?

Torisel is a drug marketed by Pf Prism Cv and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty-five patent family members in thirty-eight countries.

The generic ingredient in TORISEL is temsirolimus. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the temsirolimus profile page.

US ANDA Litigation and Generic Entry Outlook for Torisel

A generic version of TORISEL was approved as temsirolimus by ACCORD HLTHCARE on July 30th, 2018.

  Start Trial

Drug patent expirations by year for TORISEL
Drug Prices for TORISEL

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Recent Clinical Trials for TORISEL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
M.D. Anderson Cancer CenterEarly Phase 1
National Cancer Institute (NCI)Early Phase 1
NovoCure Ltd.Phase 1

See all TORISEL clinical trials

Recent Litigation for TORISEL

Identify potential future generic entrants

District Court Litigation
Case NameDate
In re: Ethicon, Inc.2015-06-03
Pfizer Inc. v. Sandoz Inc.2012-05-24
Boston Scientific Corporation v. Johnson and Johnson Inc.2007-06-01

See all TORISEL litigation

Synonyms for TORISEL
1034922-90-1
162635-04-3
343261-52-9
42-(3-Hydroxy-2-(hydroxymethyl)-2-methylpropanoate)rapamycin
42-[3-Hydroxy-2-(hydroxymethyl)-2-methylpropanoate]-rapamycin
42-[3-Hydroxy-2-methylpropanoate
624KN6GM2T
635T043
AB01274736_02
AB01274736-01
AKOS025142069
AM84554
AOB87306
BDBM50343413
BRD-K08177763-001-02-6
C56H87NO16
CAS-162635-04-3
CBPNZQVSJQDFBE-FUXHJELOSA-N
Cci 779
CCI-779
CHEBI:79699
CHEMBL1201182
DSSTox_CID_20945
DSSTox_GSID_40945
DSSTox_RID_79605
DTXSID2040945
GTPL5892
HSDB 7931
J-009958
MFCD00934421
MolPort-003-850-408
NCGC00167518-01
NCGC00167518-02
NCGC00167518-05
NSC 683864
NSC-683864
Rapamycin 42-(2,2-bis(hydroxymethyl)propionate)
Rapamycin 42-[3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate]
Rapamycin, 42-(3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate)
RL02091
RT-015903
s1044
SCHEMBL18792
SR-01000898799
SR-01000898799-3
T3574
Temserolimus
Temsirolimus
Temsirolimus - Torisel
Temsirolimus (CCI-779, NSC 683864)
Temsirolimus [USAN:INN:BAN:JAN]
Temsirolimus, >=98% (HPLC)
Temsirolimus(CCI-779)
Tox21_112515
UNII-624KN6GM2T
WAY-CCI 779
Paragraph IV (Patent) Challenges for TORISEL
Tradename Dosage Ingredient NDA Submissiondate
TORISEL SOLUTION;INTRAVENOUS temsirolimus 022088 2011-05-25

US Patents and Regulatory Information for TORISEL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pf Prism Cv TORISEL temsirolimus SOLUTION;INTRAVENOUS 022088-001 May 30, 2007 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Pf Prism Cv TORISEL temsirolimus SOLUTION;INTRAVENOUS 022088-001 May 30, 2007 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Pf Prism Cv TORISEL temsirolimus SOLUTION;INTRAVENOUS 022088-001 May 30, 2007 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Pf Prism Cv TORISEL temsirolimus SOLUTION;INTRAVENOUS 022088-001 May 30, 2007 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Pf Prism Cv TORISEL temsirolimus SOLUTION;INTRAVENOUS 022088-001 May 30, 2007 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Pf Prism Cv TORISEL temsirolimus SOLUTION;INTRAVENOUS 022088-001 May 30, 2007 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for TORISEL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0763039 SPC/GB08/025 United Kingdom   Start Trial PRODUCT NAME: TEMSIROLIMUS AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/07/424/001 20071119
0763039 C00763039/01 Switzerland   Start Trial FORMER OWNER: WYETH, US
0763039 18/2008 Austria   Start Trial PRODUCT NAME: TEMSIROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0763039 PA2008009 Lithuania   Start Trial PRODUCT NAME: TEMSIROLIMUSUM; REG. NO/DATE: EU/1/07/424/001 20071119
0763039 C300348 Netherlands   Start Trial PRODUCT NAME: TEMSIROLIMUS, DESGEWENST IN DE VORM VAN EEN; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0763039 CA 2008 00028 Denmark   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Baxter
Johnson and Johnson
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Merck

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