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Last Updated: October 25, 2020

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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. Three suppliers are listed for this compound.

Recent Clinical Trials for temsirolimus

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

SponsorPhase
Mercator MedSystems, Inc.Phase 3
Roche Pharma AGPhase 2
Ulrik LassenPhase 2

See all temsirolimus clinical trials

Paragraph IV (Patent) Challenges for TEMSIROLIMUS
Tradename Dosage Ingredient NDA Submissiondate
TORISEL SOLUTION;INTRAVENOUS temsirolimus 022088 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
Gland Pharma Ltd TEMSIROLIMUS temsirolimus SOLUTION;INTRAVENOUS 207383-001 Aug 16, 2019 AP RX No No   Start Trial   Start Trial   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 temsirolimus

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0763039 PA2008009,C0763039 Lithuania   Start Trial PRODUCT NAME: TEMSIROLIMUSUM; REGISTRATION 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 122008000023 Germany   Start Trial 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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Serving leading biopharmaceutical companies globally:

Express Scripts
Harvard Business School
Medtronic
Boehringer Ingelheim
Dow
AstraZeneca

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