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Pasireotide diaspartate - Generic Drug Details

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Pasireotide diaspartate is the generic ingredient in one branded drug marketed by Novartis 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 one hundred and sixteen patent family members in thirty-nine countries.

One supplier is listed for this compound.

Summary for Generic Name: pasireotide diaspartate

Tradenames:1
Patents:3
Applicants:1
NDAs:1
Drug Master File Entries: 0
Suppliers / Packaging: see list1
Drug Prices:see low prices

Pharmacology for Ingredient: pasireotide diaspartate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
SIGNIFOR
pasireotide diaspartate
SOLUTION;SUBCUTANEOUS200677-001Dec 14, 2012RXNo7,473,761► subscribeYY ► subscribe
Novartis
SIGNIFOR
pasireotide diaspartate
SOLUTION;SUBCUTANEOUS200677-002Dec 14, 2012RXNo► subscribe► subscribe
Novartis
SIGNIFOR
pasireotide diaspartate
SOLUTION;SUBCUTANEOUS200677-003Dec 14, 2012RXYes8,299,209► subscribeYY ► subscribe
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Expired Orange Book Patents for Generic Ingredient: pasireotide diaspartate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
SIGNIFOR
pasireotide diaspartate
SOLUTION;SUBCUTANEOUS200677-003Dec 14, 20126,225,284► subscribe
Novartis
SIGNIFOR
pasireotide diaspartate
SOLUTION;SUBCUTANEOUS200677-001Dec 14, 20126,225,284► subscribe
Novartis
SIGNIFOR
pasireotide diaspartate
SOLUTION;SUBCUTANEOUS200677-002Dec 14, 20126,225,284► subscribe
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Non-Orange Book Patents for Generic Ingredient: pasireotide diaspartate

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
8,822,637Somatostatin analogues► subscribe
9,035,021Somatostatin analogues► subscribe
7,939,625Somatostatin 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 diaspartate

Country Document Number Estimated Expiration
Canada2529449► subscribe
New Zealand544157► subscribe
Spain2328144► 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 DIASPARTATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2012016Lithuania► subscribePRODUCT NAME: PASIREOTIDUM; REGISTRATION NO/DATE: EU/1/12/753/001 - EU/1/12/753/012 20120424
8Finland► subscribe
00716Netherlands► subscribePRODUCT NAME: PASIREOTIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN OF EEN HYDRAAT DAARVAN; REGISTRATION 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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