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Last Updated: April 22, 2024

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SIGNIFOR Drug Patent 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 four patents protecting this drug.

This drug has eighty-seven 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.

DrugPatentWatch® 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
International Patents:87
US Patents:2
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 8
Clinical Trials: 7
Patent Applications: 339
Drug Prices: Drug price information for SIGNIFOR
What excipients (inactive ingredients) are in SIGNIFOR?SIGNIFOR excipients list
DailyMed Link:SIGNIFOR at DailyMed
Drug patent expirations by year for SIGNIFOR
Drug Prices for SIGNIFOR

See drug prices for SIGNIFOR

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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

SIGNIFOR is protected by two US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of SIGNIFOR is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting SIGNIFOR

Somatostatin analogues
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Pharmaceutical composition comprising cyclic somatostatin analogues
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 pasireotide diaspartate SOLUTION;SUBCUTANEOUS 200677-001 Dec 14, 2012 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Recordati Rare SIGNIFOR LAR KIT pasireotide pamoate FOR SUSPENSION;INTRAMUSCULAR 203255-005 Jun 29, 2018 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Recordati Rare SIGNIFOR LAR KIT pasireotide pamoate FOR SUSPENSION;INTRAMUSCULAR 203255-003 Dec 15, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Recordati Rare SIGNIFOR LAR KIT pasireotide pamoate FOR SUSPENSION;INTRAMUSCULAR 203255-004 Jun 29, 2018 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Recordati Rare SIGNIFOR pasireotide diaspartate SOLUTION;SUBCUTANEOUS 200677-002 Dec 14, 2012 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Recordati Rare SIGNIFOR LAR KIT pasireotide pamoate FOR SUSPENSION;INTRAMUSCULAR 203255-001 Dec 15, 2014 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a 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 200677-002 Dec 14, 2012 ⤷  Try a Trial ⤷  Try a Trial
Recordati Rare SIGNIFOR pasireotide diaspartate SOLUTION;SUBCUTANEOUS 200677-001 Dec 14, 2012 ⤷  Try a Trial ⤷  Try a Trial
Recordati Rare SIGNIFOR pasireotide diaspartate SOLUTION;SUBCUTANEOUS 200677-003 Dec 14, 2012 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for SIGNIFOR

See the table below for patents covering SIGNIFOR around the world.

Country Patent Number Title Estimated Expiration
United Kingdom 0314695 ⤷  Try a Trial
South Korea 101124136 ⤷  Try a Trial
Slovakia 1212003 Somatostatin analogues, process for their preparation and pharmaceutical compositions comprising said analogues ⤷  Try a Trial
Slovenia 835263 ⤷  Try a Trial
Russian Federation 2287533 АНАЛОГИ СОМАТОСТАТИНА (SOMATOSTATIN ANALOGUES) ⤷  Try a Trial
Hungary 0300684 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SIGNIFOR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1307486 2012/027 Ireland ⤷  Try a Trial PRODUCT NAME: PASIREOTIDE OR A SALT OR COMPLEX THEREOF; REGISTRATION NO/DATE: EU/1/12/753/001-EU/1/12/753/012 20120424
1686964 92701 Luxembourg ⤷  Try a 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
1648934 PA2012016 Lithuania ⤷  Try a Trial PRODUCT NAME: PASIREOTIDUM; REGISTRATION NO/DATE: EU/1/12/753/001 - EU/1/12/753/012 20120424
1307486 12C0041 France ⤷  Try a 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
1307486 C01307486/01 Switzerland ⤷  Try a Trial PRODUCT NAME: PASIREOTID; REGISTRATION NO/DATE: SWISSMEDIC 61254 02.11.2012
1686964 C300716 Netherlands ⤷  Try a Trial PRODUCT NAME: PASIREOTIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN OF EEN HYDRAAT DAARVAN; REGISTRATION NO/DATE: EU/1/12/753 20141119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.