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Last Updated: November 30, 2020

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SIGNIFOR Drug Profile

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Which patents cover Signifor, and what generic alternatives are available?

Signifor is a drug marketed by Recordati Rare and is included in two NDAs. There are five patents protecting this drug.

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

The generic ingredient in SIGNIFOR is pasireotide pamoate. Two suppliers are 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, 2016.

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

Indicators of Generic Entry

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

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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

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
Recordati Rare SIGNIFOR LAR KIT pasireotide pamoate FOR SUSPENSION;INTRAMUSCULAR 203255-003 Dec 15, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Recordati Rare SIGNIFOR LAR KIT pasireotide pamoate FOR SUSPENSION;INTRAMUSCULAR 203255-002 Dec 15, 2014 RX Yes No   Start Trial   Start Trial   Start Trial
Recordati Rare SIGNIFOR LAR KIT pasireotide pamoate FOR SUSPENSION;INTRAMUSCULAR 203255-003 Dec 15, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Recordati Rare SIGNIFOR LAR KIT pasireotide pamoate FOR SUSPENSION;INTRAMUSCULAR 203255-002 Dec 15, 2014 RX Yes No   Start Trial   Start Trial   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
Recordati Rare SIGNIFOR pasireotide diaspartate SOLUTION;SUBCUTANEOUS 200677-001 Dec 14, 2012   Start Trial   Start Trial
Recordati Rare SIGNIFOR pasireotide diaspartate SOLUTION;SUBCUTANEOUS 200677-003 Dec 14, 2012   Start Trial   Start Trial
Recordati Rare 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
1686964 300716 Netherlands   Start Trial PRODUCT NAME: PASIREOTIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN OF EEN HYDRAAT DAARVAN; REGISTRATION NO/DATE: EU/1/12/753 20141119
1686964 92701 Luxembourg   Start Trial PRODUCT NAME: PASIREOTIDE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE OU UN HYDRATE QUI EN DERIVE; AUTHORISATION NUMBER AND DATE: EU/1/12/753 SIGNIFOR-PASIREOTIDE 20141121
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 CR 2012 00024 Denmark   Start Trial PRODUCT NAME: PASIREOTID OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER PASIREOTIDDIASPARTAT; REG. NO/DATE: EU/1/12/753/001-012 20120424
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Express Scripts
Mallinckrodt
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Merck
AstraZeneca

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.