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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 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.

US ANDA Litigation and Generic Entry Outlook for Signifor

Signifor was eligible for patent challenges on December 14^th, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 14^th, 2026. This may change due to patent challenges or generic licensing.

Summary for SIGNIFOR

International Patents:	86
US Patents:	2
Applicants:	1
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	14
Clinical Trials:	7
Patent Applications:	39
Drug Prices:	Drug price information for SIGNIFOR
DailyMed Link:	SIGNIFOR at DailyMed

See drug prices for SIGNIFOR

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.

Recent Clinical Trials for SIGNIFOR

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Colorado, Denver	Phase 1
Hospices Civils de Lyon	Phase 2
Zealand University Hospital	Phase 4

See all SIGNIFOR clinical trials

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

International Patents for SIGNIFOR

Country	Patent Number	Estimated Expiration
Hong Kong	1089776
Argentina	044852
Hungary	227812
Mexico	PA03000991
South Korea	20030033008

Supplementary Protection Certificates for SIGNIFOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1307486	C 2012 018	Romania		PRODUCT NAME: PASIREOTIDA SI SARURILE ACCEPTABILE FARMACEUTIC ALEACESTEIACICLO[(4R)-4-(2-AMINOETILCARBAMOILOXI)-L-PROLIL-L-FENILGLICIL-D-TRIPTOFIL-L-LISIL-4-O-BENZIL-L-TIROSIL-L-FENILALANIL-); NATIONAL AUTHORISATION NUMBER: RO EU/1/12/753/001 - RO EU/1/12/753/012; DATE OF NATIONAL AUTHORISATION: 20120424; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/12/753/001 - EMEA EU/1/12/753/012; DATE OF FIRST AUTHORISATION IN EEA: 20120424
1307486	SPC/GB12/030	United Kingdom		PRODUCT NAME: CYCLO((4R)-4-(2-AMINOETHYLCARBAMOYLOXY)-L-PROLYL-L-PHENYLGLYCYL-D-TRYPTOPHYL-L-LYSYL-4-O-BENZYL-L-TYROSYL-L-PHENYLALANYL-)), PASIREOTIDE, OR SALTS THEREOF; REGISTERED: UK EU/1/12/753/001-012 20120424
1307486	2012C/026	Belgium		PRODUCT NAME: PASIREOTIDE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/12/753/001 20120426
1307486	418	Finland
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