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Pasireotide pamoate - Generic Drug Details

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

Pasireotide pamoate is the generic ingredient in one branded drug marketed by Novartis Pharms Corp and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Pasireotide pamoate has one hundred and twenty-three patent family members in fifty countries.

One supplier is listed for this compound.

Summary for pasireotide pamoate

International Patents:	123
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	3
Clinical Trials:	81
DailyMed Link:	pasireotide pamoate at DailyMed

Synonyms for pasireotide pamoate

04F55A7UZ3

396091-79-5

CHEMBL3545188

Cyclo((2S)-2-phenylglycyl-D-tryptophyl-L-lysyl-O-(phenylmethyl)-L-tyrosyl-L-phenylalanyl-(4R)-4-((((2-aminoethyl)amino)carbonyl)oxy)-L-prolyl), 4,4'-methylenebis(3-hydroxy-2-naphthalenecarboxylate) (1:1)

Pasireotide embonate

Signifor LAR

SOM-230 pamoate

SOM230 pamoate

UNII-04F55A7UZ3

US Patents and Regulatory Information for pasireotide pamoate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis Pharms Corp	SIGNIFOR LAR	pasireotide pamoate	POWDER;INTRAMUSCULAR	203255-001	Dec 15, 2014		RX	Yes	No
Novartis Pharms Corp	SIGNIFOR LAR	pasireotide pamoate	POWDER;INTRAMUSCULAR	203255-002	Dec 15, 2014		RX	Yes	No			Y
Novartis Pharms Corp	SIGNIFOR LAR	pasireotide pamoate	POWDER;INTRAMUSCULAR	203255-001	Dec 15, 2014		RX	Yes	No			Y	Y
Novartis Pharms Corp	SIGNIFOR LAR	pasireotide pamoate	POWDER;INTRAMUSCULAR	203255-001	Dec 15, 2014		RX	Yes	No			Y

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Expired US Patents for pasireotide pamoate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis Pharms Corp	SIGNIFOR LAR	pasireotide pamoate	POWDER;INTRAMUSCULAR	203255-002	Dec 15, 2014
Novartis Pharms Corp	SIGNIFOR LAR	pasireotide pamoate	POWDER;INTRAMUSCULAR	203255-001	Dec 15, 2014
Novartis Pharms Corp	SIGNIFOR LAR	pasireotide pamoate	POWDER;INTRAMUSCULAR	203255-003	Dec 15, 2014

Non-Orange Book US Patents for pasireotide pamoate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,939,625	Somatostatin analogues
9,035,021	Somatostatin analogues
8,188,037	Microparticles comprising somatostatin analogues

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International Patents for pasireotide pamoate

Country	Document Number	Estimated Expiration
China	1267451
United Kingdom	0406241
Panama	8781501
Cyprus	1110293

Supplementary Protection Certificates for pasireotide pamoate

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
90022-1	Sweden		PRODUCT NAME: PASIREOTID; REG. NO/DATE: EU/1/12/753/001 20120424
2012 00024	Denmark		PRODUCT NAME: PASIREOTID OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER PASIREOTIDDIASPARTAT; REG. NO/DATE: EU/1/12/753/001-012 20120424
024	Luxembourg		92024, EXPIRES: 20260730
2015 00026	Denmark		PRODUCT NAME: PASIREOTID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF ELLER ET HVILKET SOM HELST HYDRAT DERAF, HERUNDER PASIREOTIDDIASPARTAT; REG. NO/DATE: EU/1/12/753, C(2014)8916 20141121