Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 14, 2019

DrugPatentWatch Database Preview

Temsirolimus - Generic Drug Details

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What are the generic sources for temsirolimus and what is the scope of patent protection?

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 seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Temsirolimus has one hundred and twenty-four patent family members in thirty-eight 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
University Hospital, GrenobleN/A
Hoffmann-La RochePhase 2
Boehringer IngelheimPhase 2

See all temsirolimus clinical trials

Recent Litigation for temsirolimus

Identify potential future generic entrants

District Court Litigation
Case NameDate
In re: Ethicon, Inc.2015-06-03
Pfizer Inc. v. Sandoz Inc.2012-05-24
Boston Scientific Corporation v. Johnson and Johnson Inc.2007-06-01

See all temsirolimus litigation

Synonyms for temsirolimus
1034922-90-1
162635-04-3
343261-52-9
42-(3-Hydroxy-2-(hydroxymethyl)-2-methylpropanoate)rapamycin
42-[3-Hydroxy-2-(hydroxymethyl)-2-methylpropanoate]-rapamycin
42-[3-Hydroxy-2-(hydroxymethyl)-2-methylpropanoate]rapamycin
42-[3-Hydroxy-2-methylpropanoate
624KN6GM2T
635T043
AB01274736_02
AB01274736-01
AC-8758
AC1L3WME
AKOS025142069
AKOS025402386
AKOS032960291
AM84554
AN-5331
AOB87306
AS-11427
BC677694
BCP25281
BDBM50343413
BRD-K08177763-001-02-6
C15182
C56H87NO16
CAS-162635-04-3
CBPNZQVSJQDFBE-FUXHJELOSA-N
Cci 779
CCI-779
CCI779
CHEBI:79699
CHEMBL1201182
CS-0129
CTK8E8547
D06068
DB06287
DSSTox_CID_20945
DSSTox_GSID_40945
DSSTox_RID_79605
DTXSID2040945
EBD30128
EX-A957
GTPL5892
HSDB 7931
HY-50910
J-009958
J-524319
LS-186555
LS-187004
LS-187783
MFCD00934421
MolPort-003-850-408
MolPort-042-665-740
MolPort-044-561-110
NCGC00167518-01
NCGC00167518-02
NCGC00167518-05
NSC 683864
NSC-683864
NSC683864
Rapamycin 42-(2,2-bis(hydroxymethyl)propionate)
Rapamycin 42-[2,2-bis(hydroxymethyl)propionate]
Rapamycin 42-[3-Hydroxy-2-(hydroxymethyl)-2-methylpropanoate
Rapamycin 42-[3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate]
Rapamycin 42-[3-hydroxy-2(hydroxymethyl)-2-methylpropanoate]
Rapamycin, 42-(3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate)
RL02091
RT-015903
s1044
SCHEMBL16234472
SCHEMBL16848395
SCHEMBL18792
SR-01000898799
SR-01000898799-3
T3574
Temserolimus
Temsirolimus - Torisel
Temsirolimus (CCI-779, NSC 683864)
Temsirolimus (JAN/USAN/INN)
Temsirolimus [USAN:INN:BAN:JAN]
Temsirolimus [USAN]
Temsirolimus, >=98% (HPLC)
Temsirolimus(CCI-779)
Torisel
Torisel (TM)
Torisel (TN)
Tox21_112515
UNII-624KN6GM2T
WAY-130,779
WAY-CCI 779
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
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
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 91438 Luxembourg   Start Trial 91438, EXPIRES: 20200414
0763039 SPC017/2008 Ireland   Start Trial SPC017/2008: 20090911, EXPIRES: 20200413
0763039 PA2008009 Lithuania   Start Trial PRODUCT NAME: TEMSIROLIMUSUM; REG. 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
0763039 PA2008009,C0763039 Lithuania   Start Trial PRODUCT NAME: TEMSIROLIMUSUM; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0763039 300348 Netherlands   Start Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF LEGAL ENTITY
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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