Temsirolimus - Generic Drug Details

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. 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:	35
Clinical Trials:	221
Patent Applications:	7,597
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

Sponsor	Phase
Rapa Therapeutics LLC	Phase 2
Mercator MedSystems, Inc.	Phase 3
Roche Pharma AG	Phase 2

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					Y
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

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

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

International Patents for temsirolimus

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1553940	FORMULATIONS PARENTERALES CONTENANT UN HYDROXYESTER DE RAPAMYCINE (PARENTERAL FORMULATIONS CONTAINING A RAPAMYCIN HYDROXYESTER)
Japan	5345105
Costa Rica	7647	FORMULACIONES PARENTALES QOE CONTIENEN UN HIDROXIESTER DE RAPAMICINA
Portugal	1553940
Australia	2008236621	Anti-tumor activity of temsirolimus in papillary renal cell cancer
Brazil	PI0809322	USO DE UM COMPOSTO

Supplementary Protection Certificates for temsirolimus

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