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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. Four 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:	4
Raw Ingredient (Bulk) Api Vendors:	35
Clinical Trials:	219
Patent Applications:	7,574
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for temsirolimus
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

Sponsor	Phase
Mercator MedSystems, Inc.	Phase 3
Roche Pharma AG	Phase 2
Ulrik Lassen	Phase 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
Accord Hlthcare	TEMSIROLIMUS	temsirolimus	SOLUTION;INTRAVENOUS	203153-001	Jul 30, 2018	AP	RX	No	No
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
Gland Pharma Ltd	TEMSIROLIMUS	temsirolimus	SOLUTION;INTRAVENOUS	207383-001	Aug 16, 2019	AP	RX	No	No
Pf Prism Cv	TORISEL	temsirolimus	SOLUTION;INTRAVENOUS	022088-001	May 30, 2007	AP	RX	Yes	Yes					Y

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
Pf Prism Cv	TORISEL	temsirolimus	SOLUTION;INTRAVENOUS	022088-001	May 30, 2007

International Patents for temsirolimus

Country	Patent Number	Estimated Expiration
Japan	2010523660
Canada	2493878
South Africa	200500831
Slovenia	2462934
Taiwan	I307277
Hungary	E026022
Denmark	2144611

Supplementary Protection Certificates for temsirolimus

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0763039	PA2008009	Lithuania		PRODUCT NAME: TEMSIROLIMUSUM; REG. NO/DATE: EU/1/07/424/001 20071119
0763039	SPC/GB08/025	United Kingdom		PRODUCT NAME: TEMSIROLIMUS AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/07/424/001 20071119
0763039	18/2008	Austria		PRODUCT NAME: TEMSIROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0763039	08C0018	France		PRODUCT NAME: TEMSIROLIMUS; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0763039	C300348	Netherlands		PRODUCT NAME: TEMSIROLIMUS, DESGEWENST IN DE VORM VAN EEN; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0763039	PA2008009,C0763039	Lithuania		PRODUCT NAME: TEMSIROLIMUSUM; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0763039	122008000023	Germany		PRODUCT NAME: TEMSIROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/07/424/001 20071119