Pasireotide diaspartate - Generic Drug Details

What are the generic sources for pasireotide diaspartate and what is the scope of freedom to operate?

Pasireotide diaspartate is the generic ingredient in one branded drug marketed by Recordati Rare and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Pasireotide diaspartate has eighty-seven patent family members in thirty-nine countries.

One supplier is listed for this compound.

Summary for pasireotide diaspartate

International Patents:	87
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	23
Patent Applications:	2,200
DailyMed Link:	pasireotide diaspartate at DailyMed

Pharmacology for pasireotide diaspartate

Drug Class	Somatostatin Analog
Mechanism of Action	Somatostatin Receptor Agonists

US Patents and Regulatory Information for pasireotide diaspartate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-003	Dec 14, 2012		RX	Yes	Yes			Y	Y
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-001	Dec 14, 2012		RX	Yes	No			Y	Y
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-003	Dec 14, 2012		RX	Yes	Yes			Y	Y
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-002	Dec 14, 2012		RX	Yes	No			Y	Y
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-001	Dec 14, 2012		RX	Yes	No			Y	Y
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-002	Dec 14, 2012		RX	Yes	No			Y	Y

Expired US Patents for pasireotide diaspartate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-001	Dec 14, 2012
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-003	Dec 14, 2012
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-002	Dec 14, 2012

International Patents for pasireotide diaspartate

Country	Patent Number	Title	Estimated Expiration
Germany	60133823
Slovakia	1212003	Somatostatin analogues, process for their preparation and pharmaceutical compositions comprising said analogues
Japan	2007536195
Israel	153920	SOMATOSTATIN ANALOGUES, PROCESSES FOR THEIR PRODUCTION, PHARMACEUTICAL COMPOSITIONS COMPRISING THEM AND USE THEREOF IN THE PREPARATION OF MEDICAMENTS FOR THERAPY
New Zealand	544157	Pharmaceutical composition comprising cyclic somatostatin analogues
Denmark	1307486

Supplementary Protection Certificates for pasireotide diaspartate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1686964	92701	Luxembourg		PRODUCT NAME: PASIREOTIDE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE OU UN HYDRATE QUI EN DERIVE; AUTHORISATION NUMBER AND DATE: EU/1/12/753 SIGNIFOR-PASIREOTIDE 20141121
1686964	300716	Netherlands		PRODUCT NAME: PASIREOTIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN OF EEN HYDRAAT DAARVAN; REGISTRATION NO/DATE: EU/1/12/753 20141119
1307486	CA 2012 00024	Denmark
1648934	C20120019 00062	Estonia		PRODUCT NAME: SIGNIFOR-PASIREOTIID;REG NO/DATE: C(2012) 2910 FINAL 24.04.2012
1307486	12C0041	France		PRODUCT NAME: CYCLO((4R)-4(2-AMINOETHYLCARBAMOYLOXY)-L-PROLYL-L-PHENYLGLYCYL-D-TRYPTOPHYL-L-LYSYL-4-O-BENZYL-L-TYROSYL-L-PHENYLALANYL-) : PASIREOTIDE, OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/12/753/001 20120424
1307486	132012902062571	Italy		PRODUCT NAME: PASIREOTIDE DIASPARTATO(SIGNIFOR); AUTHORISATION NUMBER(S) AND DATE(S): EU71/12/753/001-012, 20120424