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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 temsirolimus freedom to operate?

Temsirolimus is the generic ingredient in two branded drugs marketed by Accord Hlthcare and Pf Prism Cv, and is included in two NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for temsirolimus. Two suppliers are listed for this compound.

Summary for temsirolimus

US Patents:	7
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	5
Suppliers / Packagers:	2
Bulk Api Vendors:	63
Clinical Trials:	214
Patent Applications:	3,424
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for temsirolimus
DailyMed Link:	temsirolimus at DailyMed

Synonyms for temsirolimus

(1R,2R,4S)-4-[(2R)-2-[(1R,9S,12S,15R,18R,19R,21R,23S,30S,32S,35R)-1,18-dihydroxy-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-2,3,10,14,20-pentaoxo-11,36-dioxa-4-azatricyclo[30.3.1.0;{4,9}]hexatriaconta-16,24,26,28-tetraen-12

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

AM84554

AN-5331

AOB87306

BC677694

BDBM50343413

C15182

C56H87NO16

CAS-162635-04-3

CBPNZQVSJQDFBE-FUXHJELOSA-N

Cci 779

CCI-779

CCI779

CHEBI:79699

CHEBI:93784

CHEMBL1201182

CS-0129

CTK8E8547

D06068

D0ES1Q

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

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

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)

Temsirolimus|162635-04-3|CCI-779|CCI 779|CCI779

Temsorolimus

Torisel

Torisel (TM)

Torisel (TN)

Tox21_112515

UNII-624KN6GM2T

WAY-130,779

WAY-CCI 779

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					Y
Pf Prism Cv	TORISEL	temsirolimus	SOLUTION;INTRAVENOUS	022088-001	May 30, 2007	AP	RX	Yes	Yes					Y
Pf Prism Cv	TORISEL	temsirolimus	SOLUTION;INTRAVENOUS	022088-001	May 30, 2007	AP	RX	Yes	Yes					Y
Pf Prism Cv	TORISEL	temsirolimus	SOLUTION;INTRAVENOUS	022088-001	May 30, 2007	AP	RX	Yes	Yes					Y
Pf Prism Cv	TORISEL	temsirolimus	SOLUTION;INTRAVENOUS	022088-001	May 30, 2007	AP	RX	Yes	Yes					Y
Pf Prism Cv	TORISEL	temsirolimus	SOLUTION;INTRAVENOUS	022088-001	May 30, 2007	AP	RX	Yes	Yes					Y
Accord Hlthcare	TEMSIROLIMUS	temsirolimus	SOLUTION;INTRAVENOUS	203153-001	Jul 30, 2018	AP	RX	No	No

International Patents for temsirolimus

Country	Document Number	Estimated Expiration
Spain	2586739
South Africa	9503090
Japan	3725901
Brazil	PI0809322
Argentina	090603
Panama	8776101
China	1149296

Supplementary Protection Certificates for temsirolimus

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
00348	Netherlands		PRODUCT NAME: TEMSIROLIMUS, DESGEWENST IN DE VORM VAN EEN; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
C/GB08/025	United Kingdom		PRODUCT NAME: TEMSIROLIMUS AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/07/424/001 20071119
438	Luxembourg		91438, EXPIRES: 20200414
/2008	Austria		PRODUCT NAME: TEMSIROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
C017/2008	Ireland		SPC017/2008: 20090911, EXPIRES: 20200413
C0018	France		PRODUCT NAME: TEMSIROLIMUS; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
2008009	Lithuania		PRODUCT NAME: TEMSIROLIMUSUM; REG. NO/DATE: EU/1/07/424/001 20071119