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Last Updated: April 22, 2024

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: 36
Clinical Trials: 222
Patent Applications: 6,920
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
Nader SanaiEarly Phase 1
Ivy Brain Tumor CenterEarly Phase 1
Barrow Neurological InstituteEarly Phase 1

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
Accord Hlthcare TEMSIROLIMUS temsirolimus SOLUTION;INTRAVENOUS 203153-001 Jul 30, 2018 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv TORISEL temsirolimus SOLUTION;INTRAVENOUS 022088-001 May 30, 2007 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv TORISEL temsirolimus SOLUTION;INTRAVENOUS 022088-001 May 30, 2007 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Pf Prism Cv TORISEL temsirolimus SOLUTION;INTRAVENOUS 022088-001 May 30, 2007 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Gland Pharma Ltd TEMSIROLIMUS temsirolimus SOLUTION;INTRAVENOUS 207383-001 Aug 16, 2019 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv TORISEL temsirolimus SOLUTION;INTRAVENOUS 022088-001 May 30, 2007 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv TORISEL temsirolimus SOLUTION;INTRAVENOUS 022088-001 May 30, 2007 ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv TORISEL temsirolimus SOLUTION;INTRAVENOUS 022088-001 May 30, 2007 ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv TORISEL temsirolimus SOLUTION;INTRAVENOUS 022088-001 May 30, 2007 ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv TORISEL temsirolimus SOLUTION;INTRAVENOUS 022088-001 May 30, 2007 ⤷  Try a Trial ⤷  Try a Trial
>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
South Korea 101131794 ⤷  Try a Trial
Japan 2015083595 乳頭状腎細胞癌におけるテムシロリムス(Temsirolimus)の抗腫瘍活性 (ANTI-TUMOR ACTIVITY OF TEMSIROLIMUS IN PAPILLARY RENAL CELL CARCINOMA) ⤷  Try a Trial
European Patent Office 2462934 Activité anti-tumorale du temsirolimus contre le cancer à cellules rénales papillaires (Anti-tumor activity of temsirolimus in papillary renal cell cancer) ⤷  Try a Trial
Germany 60319118 ⤷  Try a Trial
Chile 2008001009 METODO PARA TRATAR EL CARCINOMA PAPILAR DE CELULAS RENALES QUE COMPRENDE PROPORCIONAR UNA CANTIDAD DE CCI-779. ⤷  Try a Trial
South Africa 200500831 Parental formulations containing a rapamycin hydroxyester ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for temsirolimus

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0763039 PA2008009 Lithuania ⤷  Try a Trial PRODUCT NAME: TEMSIROLIMUSUM; REG. NO/DATE: EU/1/07/424/001 20071119
0763039 C300348 Netherlands ⤷  Try a Trial PRODUCT NAME: TEMSIROLIMUS, DESGEWENST IN DE VORM VAN EEN; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0763039 122008000023 Germany ⤷  Try a Trial PRODUCT NAME: TEMSIROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0763039 18/2008 Austria ⤷  Try a Trial PRODUCT NAME: TEMSIROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0763039 PA2008009,C0763039 Lithuania ⤷  Try a Trial PRODUCT NAME: TEMSIROLIMUSUM; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0763039 SPC/GB08/025 United Kingdom ⤷  Try a Trial PRODUCT NAME: TEMSIROLIMUS AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/07/424/001 20071119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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