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Last Updated: January 22, 2020

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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

  Start Trial

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

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

Summary for SIGNIFOR
Drug patent expirations by year for SIGNIFOR
Drug Prices for SIGNIFOR

See drug prices for SIGNIFOR

Generic Entry Opportunity Date for SIGNIFOR
Generic Entry Date for SIGNIFOR*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
University of Colorado, DenverPhase 1
Hospices Civils de LyonPhase 2
Zealand University HospitalPhase 4

See all SIGNIFOR clinical trials

Pharmacology for SIGNIFOR
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   Start Trial   Start Trial   Start Trial
Novartis SIGNIFOR LAR KIT pasireotide pamoate FOR SUSPENSION;INTRAMUSCULAR 203255-002 Dec 15, 2014 RX Yes No   Start Trial   Start Trial Y   Start Trial
Novartis SIGNIFOR LAR KIT pasireotide pamoate FOR SUSPENSION;INTRAMUSCULAR 203255-002 Dec 15, 2014 RX Yes No   Start Trial   Start Trial   Start Trial
Novartis SIGNIFOR LAR KIT pasireotide pamoate FOR SUSPENSION;INTRAMUSCULAR 203255-002 Dec 15, 2014 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Novartis SIGNIFOR pasireotide diaspartate SOLUTION;SUBCUTANEOUS 200677-001 Dec 14, 2012 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Supplementary Protection Certificates for SIGNIFOR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1307486 C 2012 018 Romania   Start Trial 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   Start Trial 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   Start Trial PRODUCT NAME: PASIREOTIDE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/12/753/001 20120426
1307486 418 Finland   Start Trial
1307486 12C0041 France   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Baxter
AstraZeneca
McKinsey
Dow
Mallinckrodt
Colorcon

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