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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:	13
Clinical Trials:	7
Patent Applications:	36
Drug Prices:	Drug price information for SIGNIFOR
Prior Art and Litigation Support	Order Prior Art and Litigation support 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

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)

DB06663

GTPL2018

HY-16381

I4P76SY3N4

pasireotida

Pasireotide

Pasireotide [USAN:INN]

pasireotide aspartate

Pasireotide diaspartate

Pasireotide diaspartate [EMA EPAR]

pasireotidum

SCHEMBL12462108

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
Novartis	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-003	Dec 14, 2012		RX	Yes	Yes			Y	Y

Expired US Patents for SIGNIFOR

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

International Patents for SIGNIFOR

Country	Patent Number	Estimated Expiration
Slovakia	1212003
United Kingdom	0018891
Hungary	0300684
Norway	330706
Cyprus	1109444
Poland	204161

Supplementary Protection Certificates for SIGNIFOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1307486	1290022-1	Sweden		PRODUCT NAME: PASIREOTID; REG. NO/DATE: EU/1/12/753/001 20120424
1307486	CA 2012 00024	Denmark
1307486	C01307486/01	Switzerland		PRODUCT NAME: PASIREOTID; REGISTRATION NO/DATE: SWISSMEDIC 61254 02.11.2012
1686964	92701	Luxembourg		PRODUCT NAME: PASIREOTIDE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE OU UN HYDRATE QUI EN DERIVE . FIRST REGISTRATION: 20141121
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
1307486	92024	Luxembourg		92024, EXPIRES: 20260730