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Last Updated: November 14, 2019

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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.

Summary for temsirolimus

International Patents:	124
US Patents:	7
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	5
Suppliers / Packagers:	3
Bulk Api Vendors:	70
Clinical Trials:	216
Patent Applications:	3,957
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for temsirolimus
DailyMed Link:	temsirolimus at DailyMed

Recent Clinical Trials for temsirolimus

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Sponsor	Phase
University Hospital, Grenoble	N/A
Hoffmann-La Roche	Phase 2
Boehringer Ingelheim	Phase 2

See all temsirolimus clinical trials

Recent Litigation for temsirolimus

Identify potential future generic entrants

District Court Litigation

Case Name	Date
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

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Glossary

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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

Expired US Patents for temsirolimus

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pf Prism Cv	TORISEL	temsirolimus	SOLUTION;INTRAVENOUS	022088-001	May 30, 2007	Start Trial	Start Trial
Pf Prism Cv	TORISEL	temsirolimus	SOLUTION;INTRAVENOUS	022088-001	May 30, 2007	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for temsirolimus

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Country	Patent Number	Estimated Expiration
Israel	113179	Start Trial
Canada	2493878	Start Trial
European Patent Office	3106164	Start Trial
Cyprus	1116492	Start Trial
Mexico	2009010954	Start Trial
China	100402031	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for temsirolimus

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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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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 verifification 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.

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