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Pasireotide pamoate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for pasireotide pamoate?

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

This ingredient has seventy-seven patent family members in thirty-six countries.

One supplier is listed for this compound.

Summary for Generic Name: pasireotide pamoate

Tradenames:1
Patents:4
Applicants:1
NDAs:1
Drug Master File Entries: 0
Suppliers / Packagers: see list1
Clinical Trials: see list32
Drug Prices:see low prices
DailyMed Link:pasireotide pamoate at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis Pharms Corp
SIGNIFOR LAR
pasireotide pamoate
POWDER;INTRAMUSCULAR203255-002Dec 15, 2014RXYesNo8,822,637► Subscribe ► Subscribe
Novartis Pharms Corp
SIGNIFOR LAR
pasireotide pamoate
POWDER;INTRAMUSCULAR203255-003Dec 15, 2014RXYesYes► Subscribe► Subscribe
Novartis Pharms Corp
SIGNIFOR LAR
pasireotide pamoate
POWDER;INTRAMUSCULAR203255-003Dec 15, 2014RXYesYes7,473,761► SubscribeYY ► Subscribe
Novartis Pharms Corp
SIGNIFOR LAR
pasireotide pamoate
POWDER;INTRAMUSCULAR203255-003Dec 15, 2014RXYesYes8,822,637► Subscribe ► Subscribe
Novartis Pharms Corp
SIGNIFOR LAR
pasireotide pamoate
POWDER;INTRAMUSCULAR203255-001Dec 15, 2014RXYesNo► 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 Corp
SIGNIFOR LAR
pasireotide pamoate
POWDER;INTRAMUSCULAR203255-003Dec 15, 20146,225,284► Subscribe
Novartis Pharms Corp
SIGNIFOR LAR
pasireotide pamoate
POWDER;INTRAMUSCULAR203255-001Dec 15, 20146,225,284► Subscribe
Novartis Pharms Corp
SIGNIFOR LAR
pasireotide pamoate
POWDER;INTRAMUSCULAR203255-002Dec 15, 20146,225,284► 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
8,188,037Microparticles comprising somatostatin analogues► Subscribe
7,939,625Somatostatin 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
Slovenia1686964► Subscribe
Canada2416293► Subscribe
European Patent Office1686964► Subscribe
Slovenia1307486► Subscribe
MexicoPA06005357► 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
8Finland► Subscribe
C/GB12/030United Kingdom► SubscribePRODUCT 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
701Luxembourg► SubscribePRODUCT NAME: PASIREOTIDE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE OU UN HYDRATE QUI EN DERIVE . FIRST REGISTRATION: 20141121
024Luxembourg► Subscribe92024, EXPIRES: 20260730
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
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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 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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