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Generated: December 12, 2017

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Pasireotide pamoate - Generic Drug Details

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What are the generic drug sources for pasireotide pamoate and what is the scope of pasireotide pamoate freedom to operate?

Pasireotide pamoate
is the generic ingredient in one branded drug marketed by Novartis Pharms Corp and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Pasireotide pamoate has one hundred and twenty-three patent family members in fifty countries and eighteen supplementary protection certificates in twelve countries.

One supplier is listed for this compound.

Summary for pasireotide pamoate

US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Clinical Trials: 81
Drug Prices:see low prices
DailyMed Link:pasireotide pamoate at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Novartis Pharms CorpSIGNIFOR LARpasireotide pamoatePOWDER;INTRAMUSCULAR203255-001Dec 15, 2014RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Novartis Pharms CorpSIGNIFOR LARpasireotide pamoatePOWDER;INTRAMUSCULAR203255-001Dec 15, 2014RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Novartis Pharms CorpSIGNIFOR LARpasireotide pamoatePOWDER;INTRAMUSCULAR203255-002Dec 15, 2014RXYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
Novartis Pharms CorpSIGNIFOR LARpasireotide pamoatePOWDER;INTRAMUSCULAR203255-001Dec 15, 2014RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Novartis Pharms CorpSIGNIFOR LARpasireotide pamoatePOWDER;INTRAMUSCULAR203255-002Dec 15, 2014RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Novartis Pharms CorpSIGNIFOR LARpasireotide pamoatePOWDER;INTRAMUSCULAR203255-002Dec 15, 2014RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Novartis Pharms CorpSIGNIFOR LARpasireotide pamoatePOWDER;INTRAMUSCULAR203255-003Dec 15, 2014RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Novartis Pharms CorpSIGNIFOR LARpasireotide pamoatePOWDER;INTRAMUSCULAR203255-001Dec 15, 2014RXYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
Novartis Pharms CorpSIGNIFOR LARpasireotide pamoatePOWDER;INTRAMUSCULAR203255-003Dec 15, 2014RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Novartis Pharms CorpSIGNIFOR LARpasireotide pamoatePOWDER;INTRAMUSCULAR203255-002Dec 15, 2014RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: pasireotide pamoate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms CorpSIGNIFOR LARpasireotide pamoatePOWDER;INTRAMUSCULAR203255-003Dec 15, 2014► Subscribe► Subscribe
Novartis Pharms CorpSIGNIFOR LARpasireotide pamoatePOWDER;INTRAMUSCULAR203255-001Dec 15, 2014► Subscribe► Subscribe
Novartis Pharms CorpSIGNIFOR LARpasireotide pamoatePOWDER;INTRAMUSCULAR203255-002Dec 15, 2014► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: pasireotide pamoate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,939,625Somatostatin analogues► Subscribe
8,188,037Microparticles comprising somatostatin analogues► Subscribe
9,035,021Somatostatin analogues► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: pasireotide pamoate

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)0210192► Subscribe
Russian Federation2404749► Subscribe
Portugal1307486► Subscribe
Japan2004505095► Subscribe
Brazil0112859► Subscribe
Cyprus1110293► Subscribe
Malaysia158342► Subscribe
Tunisia2009000447► Subscribe
EcuadorSP034456► Subscribe
South Korea20100017904► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: PASIREOTIDE PAMOATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
12/027Ireland► SubscribePRODUCT NAME: PASIREOTIDE OR A SALT OR COMPLEX THEREOF; REGISTRATION NO/DATE: EU/1/12/753/001-EU/1/12/753/012 20120424
C0041France► SubscribePRODUCT 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
2012 00024Denmark► SubscribePRODUCT NAME: PASIREOTID OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER PASIREOTIDDIASPARTAT; REG. NO/DATE: EU/1/12/753/001-012 20120424
2012 00024Denmark► Subscribe
701Luxembourg► SubscribePRODUCT NAME: PASIREOTIDE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE OU UN HYDRATE QUI EN DERIVE . FIRST REGISTRATION: 20141121
2015 00026Denmark► SubscribePRODUCT 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
2015 00026Denmark► SubscribePRODUCT NAME: PASIREOTID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF ELLER ET HVILKET SOM HELST HYDRAT DERAF, HERUNDER PASIREOTIDDIASPARTAT; REG. NO/DATE: EU/1/12/753, C(2014)8916 20141121
00536Netherlands► SubscribePRODUCT NAME: PASIREOTIDE, DESGEWENST IN DE VORM VAN EEN ZOUT, IN HET BIJZONDER PASIREOTIDEDI-ASPARTAAT; REGISTRATION NO/DATE: EU/1/12/753/001-012 20120424
7 5005-2015Slovakia► SubscribePRODUCT 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
2012000045Germany► SubscribePRODUCT NAME: PASIREOTID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON ODER EIN KOMPLEX HIERVON; REGISTRATION NO/DATE: EU/1/12/753/001-012 20120424
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Serving leading biopharmaceutical companies globally:

Healthtrust
Harvard Business School
Citi
Dow
Fuji
Teva
Fish and Richardson
AstraZeneca
Accenture
Julphar

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 verifification 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.

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