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Last Updated: July 13, 2024

TEMSIROLIMUS - Generic Drug Details


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What are the generic 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: 7,487
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
Pf Prism Cv TORISEL temsirolimus SOLUTION;INTRAVENOUS 022088-001 May 30, 2007 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Gland Pharma Ltd TEMSIROLIMUS temsirolimus SOLUTION;INTRAVENOUS 207383-001 Aug 16, 2019 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pf Prism Cv TORISEL temsirolimus SOLUTION;INTRAVENOUS 022088-001 May 30, 2007 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Pf Prism Cv TORISEL temsirolimus SOLUTION;INTRAVENOUS 022088-001 May 30, 2007 ⤷  Sign Up ⤷  Sign Up
Pf Prism Cv TORISEL temsirolimus SOLUTION;INTRAVENOUS 022088-001 May 30, 2007 ⤷  Sign Up ⤷  Sign Up
>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
Japan 2010163466 PARENTERAL FORMULATION CONTAINING RAPAMYCIN HYDROXYESTER ⤷  Sign Up
Taiwan 200901989 Anti-tumor activity of CCI-779 in papillary renal cell cancer ⤷  Sign Up
Chile 2008001009 METODO PARA TRATAR EL CARCINOMA PAPILAR DE CELULAS RENALES QUE COMPRENDE PROPORCIONAR UNA CANTIDAD DE CCI-779. ⤷  Sign Up
>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 ⤷  Sign Up PRODUCT NAME: TEMSIROLIMUS; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0763039 PA2008009,C0763039 Lithuania ⤷  Sign Up PRODUCT NAME: TEMSIROLIMUSUM; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0763039 18/2008 Austria ⤷  Sign Up 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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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.