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SIGNIFOR Drug Profile

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When do Signifor patents expire, and what generic alternatives are available?

Signifor is a drug marketed by Novartis and Novartis Pharms Corp and is included in two NDAs. There are five patents protecting this drug.

This drug has eighty-six patent family members in thirty-nine countries.

The generic ingredient in SIGNIFOR is pasireotide pamoate. One supplier is listed for this compound. Additional details are available on the pasireotide pamoate profile page.

Summary for SIGNIFOR

International Patents:	86
US Patents:	2
Applicants:	2
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	1
Clinical Trials:	5
Drug Prices:	Drug price information for SIGNIFOR
DailyMed Link:	SIGNIFOR at DailyMed

Generic Entry Opportunity Date for SIGNIFOR

NDA:

200677

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 SIGNIFOR

Drug Class	Somatostatin Analog
Mechanism of Action	Somatostatin Receptor Agonists

Synonyms for SIGNIFOR

[(3S,6S,9S,12R,15S,18S,20R)-9-(4-aminobutyl)-12-(1H-indol-3-ylmethyl)-2,5,8,11,14,17-hexaoxo-15-phenyl-6-[[4-(phenylmethoxy)phenyl]methyl]-3-(phenylmethyl)-1,4,7,10,13,16-hexazabicyclo[16.3.0]henicosan-20-yl] N-(2-aminoethyl)

396091-73-9

820232-50-6

98H1T17066

AKOS030526804

CHEBI:72312

CHEBI:72313

CHEMBL3349607

CS-2328

Cyclo((2R)-2-phenylglycyl-d-tryptophyl-l-lysyl-o-(phenylmethyl)-l-tyrosyl-l-phenylalanyl-(4R)-4-((((2-aminoethyl)amino)carbonyl)oxy)-l-prolyl), l-aspartate (1:2)

cyclo((4R)-4-(2-aminoethylcarbamoyloxy)-L-prolyl-L-phenylglycyl-D-tryptophyl-L-lysyl-4-O-benzyl-L-tyrosyl-L- phenylalanyl-)

Cyclo((4R)-4-(2-aminoethylcarbamoyloxy)-L-prolyl-L-phenylglycyl-D-tryptophyl-L-lysyl-4-O-benzyl-L-tyrosyl-L-phenylalanyl-)

cyclo[(2S)-2-phenylglycyl-D-tryptophyl-6-azaniumyl-L-norleucyl-O-benzyl-L-tyrosyl-L-phenylalanyl-(4R)-4-{[(2-ammonioethyl)carbamoyl]oxy}-L-prolyl] bis[(2S)-2-azaniumylsuccinate]

cyclo[(2S)-2-phenylglycyl-D-tryptophyl-L-lysyl-O-benzyl-L-tyrosyl-L-phenylalanyl-(4R)-4-{[(2-aminoethyl)carbamoyl]oxy}-L-prolyl]

cyclo[(2S)-2-phenylglycyl-D-tryptophyl-L-lysyl-O-benzyl-L-tyrosyl-L-phenylalanyl-(4R)-4-{[(2-aminoethyl)carbamoyl]oxy}-L-prolyl] bis-(L-aspartate)

D0TV0C

DB06663

GTPL2018

HY-16381

I4P76SY3N4

pasireotida

Pasireotide

Pasireotide [USAN:INN]

pasireotide aspartate

Pasireotide diaspartate

Pasireotide diaspartate [EMA EPAR]

pasireotidum

SCHEMBL12462108

Signifor (TN)

Signifor LAR

SOM 230

SOM 230|||SOM 320

SOM 320

SOM-230

SOM230

UNII-98H1T17066

UNII-I4P76SY3N4

US Patents and Regulatory Information for SIGNIFOR

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 KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-003	Dec 15, 2014		RX	Yes	Yes
Novartis Pharms Corp	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-003	Dec 15, 2014		RX	Yes	Yes
Novartis	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-001	Dec 14, 2012		RX	Yes	No			Y	Y
Novartis Pharms Corp	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-002	Dec 15, 2014		RX	Yes	No
Novartis Pharms Corp	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-003	Dec 15, 2014		RX	Yes	Yes

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Expired US Patents for SIGNIFOR

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

Non-Orange Book US Patents for SIGNIFOR

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
8,822,637	Somatostatin analogues

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International Patents for SIGNIFOR

Country	Document Number	Estimated Expiration
China	1812997
Argentina	034132
Poland	358718
Brazil	PI0112859
Portugal	1307486

Supplementary Protection Certificates for SIGNIFOR

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2012 00024	Denmark		PRODUCT NAME: PASIREOTID OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER PASIREOTIDDIASPARTAT; REG. NO/DATE: EU/1/12/753/001-012 20120424
C0041	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
2012 00024	Denmark
2012000045	Germany		PRODUCT NAME: PASIREOTID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON ODER EIN KOMPLEX HIERVON; REGISTRATION NO/DATE: EU/1/12/753/001-012 20120424
2012016	Lithuania		PRODUCT NAME: PASIREOTIDUM; REGISTRATION NO/DATE: EU/1/12/753/001 - EU/1/12/753/012 20120424