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Last Updated: September 25, 2022

SIGNIFOR LAR KIT Drug Patent Profile


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

Signifor Lar Kit is a drug marketed by Recordati Rare and is included in one NDA. There are four patents protecting this drug.

This drug has one hundred and thirty-five patent family members in fifty-three countries.

The generic ingredient in SIGNIFOR LAR KIT is pasireotide pamoate. Two suppliers are listed for this compound. Additional details are available on the pasireotide pamoate profile page.

DrugPatentWatch® Generic Entry Outlook for Signifor Lar Kit

Signifor Lar Kit 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 May 23, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for SIGNIFOR LAR KIT
International Patents:135
US Patents:4
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 2
Clinical Trials: 7
DailyMed Link:SIGNIFOR LAR KIT at DailyMed
Drug patent expirations by year for SIGNIFOR LAR KIT
DrugPatentWatch® Estimated Generic Entry Opportunity Date for SIGNIFOR LAR KIT
Generic Entry Date for SIGNIFOR LAR KIT*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
FOR SUSPENSION;INTRAMUSCULAR

*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 LAR KIT

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 LAR KIT clinical trials

US Patents and Regulatory Information for SIGNIFOR LAR KIT

SIGNIFOR LAR KIT is protected by four US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of SIGNIFOR LAR KIT is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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 LAR KIT

Somatostatin analogues
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Microparticles comprising somatostatin analogues
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Somatostatin analogues
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING ACROMEGALY

Extended-release composition comprising a somatostatin derivative in microparticles
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting SIGNIFOR LAR KIT

INDICATED FOR TREATMENT OF PATIENTS WITH CUSHING'S DISEASE FOR WHOM PITUITARY SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE
Exclusivity Expiration: See Plans and Pricing

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 203255-004 Jun 29, 2018 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Recordati Rare SIGNIFOR LAR KIT pasireotide pamoate FOR SUSPENSION;INTRAMUSCULAR 203255-002 Dec 15, 2014 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Recordati Rare SIGNIFOR LAR KIT pasireotide pamoate FOR SUSPENSION;INTRAMUSCULAR 203255-001 Dec 15, 2014 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Recordati Rare SIGNIFOR LAR KIT pasireotide pamoate FOR SUSPENSION;INTRAMUSCULAR 203255-004 Jun 29, 2018 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Recordati Rare SIGNIFOR LAR KIT pasireotide pamoate FOR SUSPENSION;INTRAMUSCULAR 203255-005 Jun 29, 2018 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Recordati Rare SIGNIFOR LAR KIT pasireotide pamoate FOR SUSPENSION;INTRAMUSCULAR 203255-003 Dec 15, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Recordati Rare SIGNIFOR LAR KIT pasireotide pamoate FOR SUSPENSION;INTRAMUSCULAR 203255-001 Dec 15, 2014 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 LAR KIT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Recordati Rare SIGNIFOR LAR KIT pasireotide pamoate FOR SUSPENSION;INTRAMUSCULAR 203255-003 Dec 15, 2014 See Plans and Pricing See Plans and Pricing
Recordati Rare SIGNIFOR LAR KIT pasireotide pamoate FOR SUSPENSION;INTRAMUSCULAR 203255-001 Dec 15, 2014 See Plans and Pricing See Plans and Pricing
Recordati Rare SIGNIFOR LAR KIT pasireotide pamoate FOR SUSPENSION;INTRAMUSCULAR 203255-002 Dec 15, 2014 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for SIGNIFOR LAR KIT

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

Country Patent Number Title Estimated Expiration
European Patent Office 1686964 COMPOSITION PHARMACEUTIQUE (MICROPARTICLES COMPRISING SOMATOSTATIN ANALOGUES) See Plans and Pricing
Czech Republic 2003288 See Plans and Pricing
Japan 2004505095 See Plans and Pricing
South Africa 200300406 Somatostatin analogues. See Plans and Pricing
Hong Kong 1057051 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2005046645 See Plans and Pricing
San Marino P200900099 Composizione a rilascio protratto comprendente un derivato della somatostatina in microparticelle. See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SIGNIFOR LAR KIT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1686964 C 2015 008 Romania See Plans and Pricing PRODUCT NAME: PASIREOTIDA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIASAU ORICE HIDRAT AL ACESTEIACICLO[(4R)-4-(2-AMINOETILCARBAMOILOXI)-L-PROLIL-L-FENILGLICIL-D-TRIPTOFIL-L-LISIL-4-O-BENZIL-L-TIROSIL-L-FENILALANIL-); NATIONAL AUTHORISATION NUMBER: EU/1/12/753/013, EU/1/12/753/014, EU/1/12/753/015, EU/1/12/753/016, EU/1/12/753/017; DATE OF NATIONAL AUTHORISATION: 20141119; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/753/013, EU/1/12/753/014, EU/1/12/753/015, EU/1/12/753/016, EU/1/12/753/017; DATE OF FIRST AUTHORISATION IN EEA: 20141119
1307486 132012902062571 Italy See Plans and Pricing PRODUCT NAME: PASIREOTIDE DIASPARTATO(SIGNIFOR); AUTHORISATION NUMBER(S) AND DATE(S): EU71/12/753/001-012, 20120424
1307486 CR 2012 00024 Denmark See Plans and Pricing PRODUCT NAME: PASIREOTID OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER PASIREOTIDDIASPARTAT; REG. NO/DATE: EU/1/12/753/001-012 20120424
1307486 92024 Luxembourg See Plans and Pricing 92024, EXPIRES: 20260730
1686964 CA 2015 00026 Denmark See Plans and Pricing PRODUCT NAME: PASIREOTID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF ELLER ET HVILKET SOM HELST HYDRAT DERAF, HERUNDER PASIREOTIDDIASPARTAT; REG. NO/DATE: EU/1/12/753 20141119
1307486 418 Finland See Plans and Pricing
1686964 197 5005-2015 Slovakia See Plans and Pricing PRODUCT NAME: PASIREOTID ALEBO JEHO FARMACEUTICKY PRIJATEL- NA SOL ALEBO AKYKOLVEK JEHO HYDRAT; REGISTRATION NO/DATE: EU/1/12/753/001 - EU/1/12/753/017 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.