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Last Updated: January 30, 2023

Temsirolimus - Generic Drug Details


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What are the generic drug sources for temsirolimus and what is the scope of freedom to operate?

Temsirolimus is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Gland Pharma Ltd, and Pf Prism Cv, and is included in three NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Temsirolimus has seventy-six patent family members in thirty-three countries.

There are five drug master file entries for temsirolimus. Five suppliers are listed for this compound.

Summary for temsirolimus
International Patents:76
US Patents:5
Tradenames:2
Applicants:3
NDAs:3
Drug Master File Entries: 5
Finished Product Suppliers / Packagers: 5
Raw Ingredient (Bulk) Api Vendors: 35
Clinical Trials: 221
Patent Applications: 7,597
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in temsirolimus?temsirolimus excipients list
DailyMed Link:temsirolimus at DailyMed
Recent Clinical Trials for temsirolimus

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

SponsorPhase
Rapa Therapeutics LLCPhase 2
Mercator MedSystems, Inc.Phase 3
Roche Pharma AGPhase 2

See all temsirolimus clinical trials

Paragraph IV (Patent) Challenges for TEMSIROLIMUS
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 temsirolimus

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
Accord Hlthcare TEMSIROLIMUS temsirolimus SOLUTION;INTRAVENOUS 203153-001 Jul 30, 2018 AP RX No No See Plans and Pricing See Plans and Pricing 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 temsirolimus

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 temsirolimus

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 temsirolimus

Country Patent Number Title Estimated Expiration
European Patent Office 1553940 FORMULATIONS PARENTERALES CONTENANT UN HYDROXYESTER DE RAPAMYCINE (PARENTERAL FORMULATIONS CONTAINING A RAPAMYCIN HYDROXYESTER) See Plans and Pricing
Japan 5345105 See Plans and Pricing
Costa Rica 7647 FORMULACIONES PARENTALES QOE CONTIENEN UN HIDROXIESTER DE RAPAMICINA See Plans and Pricing
Portugal 1553940 See Plans and Pricing
Australia 2008236621 Anti-tumor activity of temsirolimus in papillary renal cell cancer See Plans and Pricing
Brazil PI0809322 USO DE UM COMPOSTO See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for temsirolimus

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0763039 08C0018 France See Plans and Pricing PRODUCT NAME: TEMSIROLIMUS; 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 18/2008 Austria See Plans and Pricing PRODUCT NAME: TEMSIROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0763039 SPC/GB08/025 United Kingdom See Plans and Pricing PRODUCT NAME: TEMSIROLIMUS AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/07/424/001 20071119
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 122008000023 Germany See Plans and Pricing PRODUCT NAME: TEMSIROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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