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:	47
Patent Applications:	1,793
DailyMed Link:	pasireotide diaspartate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for pasireotide diaspartate

Dosage:

SOLUTION;SUBCUTANEOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for pasireotide diaspartate

Drug Class	Somatostatin Analog
Mechanism of Action	Somatostatin Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for pasireotide diaspartate

H01CB	Somatostatin and analogues
H01C	HYPOTHALAMIC HORMONES
H01	PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
H	Systemic hormonal preparations, excluding sex hormones and insulins

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	200677-001	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	200677-002	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

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
Denmark	1648934
Iceland	8247	Lyfjablanda sem felur í sér hringtengdar vaxtarhormónsandvakahliðstæður
Slovakia	1212003	Somatostatin analogues, process for their preparation and pharmaceutical compositions comprising said analogues
New Zealand	523836	Somatostatin analogues
Mexico	PA05013821	COMPOSICION FARMACEUTICA QUE COMPRENDE ANALOGOS DE SOMATOSTATINA CICLICOS. (PHARMACEUTICAL COMPOSITION.)

Supplementary Protection Certificates for pasireotide diaspartate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1686964	C300716	Netherlands		PRODUCT NAME: PASIREOTIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN OF EEN HYDRAAT DAARVAN; REGISTRATION NO/DATE: EU/1/12/753 20141119
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
1307486	92024	Luxembourg		92024, EXPIRES: 20260730
1307486	122012000045	Germany		PRODUCT NAME: PASIREOTID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON ODER EIN KOMPLEX HIERVON; REGISTRATION NO/DATE: EU/1/12/753/001-012 20120424
1648934	PA2012016	Lithuania		PRODUCT NAME: PASIREOTIDUM; REGISTRATION NO/DATE: EU/1/12/753/001 - EU/1/12/753/012 20120424