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Last Updated: August 12, 2020

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TORISEL Drug Profile

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Which patents cover Torisel, and when can generic versions of Torisel launch?

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

This drug has seventy-six patent family members in thirty-three 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

See drug prices for TORISEL

Recent Clinical Trials for TORISEL

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

SponsorPhase
Shanghai Children's Medical CenterPhase 4
Roche Pharma AGPhase 2
Ulrik LassenPhase 2

See all TORISEL clinical trials

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
>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 SPC017/2008 Ireland   Start Trial SPC017/2008: 20090911, EXPIRES: 20200413
0763039 CA 2008 00028 Denmark   Start Trial
0763039 C00763039/01 Switzerland   Start Trial FORMER OWNER: WYETH, US
0763039 C300348 Netherlands   Start Trial PRODUCT NAME: TEMSIROLIMUS, DESGEWENST IN DE VORM VAN EEN; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Johnson and Johnson
Express Scripts
Moodys
Medtronic
Colorcon

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