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Last Updated: August 15, 2022

TORISEL Drug Patent 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. Four suppliers are listed for this compound. Additional details are available on the temsirolimus profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Torisel

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

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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
Roche Pharma AGPhase 2
GlaxoSmithKlinePhase 2
Ulrik LassenPhase 2

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Paragraph IV (Patent) Challenges for TORISEL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TORISEL Injection temsirolimus 25 mg/mL, 1.8 mL vial 022088 1 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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Pf Prism Cv TORISEL temsirolimus SOLUTION;INTRAVENOUS 022088-001 May 30, 2007 AP RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Pf Prism Cv TORISEL temsirolimus SOLUTION;INTRAVENOUS 022088-001 May 30, 2007 AP RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Pf Prism Cv TORISEL temsirolimus SOLUTION;INTRAVENOUS 022088-001 May 30, 2007 AP RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Pf Prism Cv TORISEL temsirolimus SOLUTION;INTRAVENOUS 022088-001 May 30, 2007 AP RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for TORISEL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv TORISEL temsirolimus SOLUTION;INTRAVENOUS 022088-001 May 30, 2007 See Plans and Pricing See Plans and Pricing
Pf Prism Cv TORISEL temsirolimus SOLUTION;INTRAVENOUS 022088-001 May 30, 2007 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for TORISEL

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Pfizer Europe MA EEIG Torisel temsirolimus EMEA/H/C/000799
Renal-cell carcinomaTorisel is indicated for the first-line treatment of adult patients with advanced renal-cell carcinoma (RCC) who have at least three of six prognostic risk factors.Mantle-cell lymphomaTorisel is indicated for the treatment of adult patients with relapsed and / or refractory mantle-cell lymphoma (MCL).
Authorised no no no 2007-11-19
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for TORISEL

See the table below for patents covering TORISEL around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 2144611 Activité anti-tumorale du temsirolimus contre le cancer à cellules rénales papillaires (Anti-tumor activity of temsirolimus in papillary renal cell cancer) See Plans and Pricing
World Intellectual Property Organization (WIPO) 9528406 See Plans and Pricing
Japan 2005537285 See Plans and Pricing
Denmark 2144611 See Plans and Pricing
Hungary 225915 RAPAMYCIN HYDROXYALKYLESTERS, PROCESS FOR THEIR PREPARATION, THEIR USE AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM See Plans and Pricing
Japan 2010163466 PARENTERAL FORMULATION CONTAINING RAPAMYCIN HYDROXYESTER See Plans and Pricing
Taiwan 200403073 Parenteral formulations See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TORISEL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0763039 PA2008009,C0763039 Lithuania See Plans and Pricing PRODUCT NAME: TEMSIROLIMUSUM; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0763039 91438 Luxembourg See Plans and Pricing 91438, EXPIRES: 20200414
0763039 C300348 Netherlands See Plans and Pricing PRODUCT NAME: TEMSIROLIMUS, DESGEWENST IN DE VORM VAN EEN; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0763039 PA2008009 Lithuania See Plans and Pricing PRODUCT NAME: TEMSIROLIMUSUM; REG. NO/DATE: EU/1/07/424/001 20071119
0763039 08C0018 France See Plans and Pricing PRODUCT NAME: TEMSIROLIMUS; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0763039 SPC017/2008 Ireland See Plans and Pricing SPC017/2008: 20090911, EXPIRES: 20200413
0763039 C00763039/01 Switzerland See Plans and Pricing FORMER OWNER: WYETH, US
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.