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Generated: August 20, 2017
What is the patent landscape for Signifor, and what generic Signifor alternatives are available?
Signifor is a drug marketed by Novartis and Novartis Pharms Corp and is included in two NDAs. There are four patents protecting this drug.| Patents: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Suppliers / Packagers: see list | 1 |
| Bulk Api Vendors: see list | 5 |
| Clinical Trials: see list | 5 |
| Drug Prices: | see details |
| DailyMed Link: | SIGNIFOR at DailyMed |
| Drug Class | Somatostatin Analog |
| Mechanism of Action | Somatostatin Receptor Agonists |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis Pharms Corp | SIGNIFOR LAR | pasireotide pamoate | POWDER;INTRAMUSCULAR | 203255-003 | Dec 15, 2014 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Novartis Pharms Corp | SIGNIFOR LAR | pasireotide pamoate | POWDER;INTRAMUSCULAR | 203255-003 | Dec 15, 2014 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Novartis | SIGNIFOR | pasireotide diaspartate | SOLUTION;SUBCUTANEOUS | 200677-001 | Dec 14, 2012 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Novartis Pharms Corp | SIGNIFOR LAR | pasireotide pamoate | POWDER;INTRAMUSCULAR | 203255-001 | Dec 15, 2014 | RX | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Novartis Pharms Corp | SIGNIFOR LAR | pasireotide pamoate | POWDER;INTRAMUSCULAR | 203255-002 | Dec 15, 2014 | RX | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | SIGNIFOR | pasireotide diaspartate | SOLUTION;SUBCUTANEOUS | 200677-001 | Dec 14, 2012 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Novartis | SIGNIFOR | pasireotide diaspartate | SOLUTION;SUBCUTANEOUS | 200677-003 | Dec 14, 2012 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Novartis | SIGNIFOR | pasireotide diaspartate | SOLUTION;SUBCUTANEOUS | 200677-002 | Dec 14, 2012 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,939,625 | Somatostatin analogues | ► Subscribe | |||||||||||||||||||||||||||
| 9,035,021 | Somatostatin analogues | ► Subscribe | |||||||||||||||||||||||||||
| 8,822,637 | Somatostatin 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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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Chile | 2004001579 | ► Subscribe | |||||||||||||||||||||||||||
| Taiwan | 200514789 | ► Subscribe | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 2005000893 | ► Subscribe | |||||||||||||||||||||||||||
| Russian Federation | 2287533 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2004505095 | ► 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 Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8 | Finland | ► Subscribe | |||||||||||||||||||||||||||
| 00716 | Netherlands | ► Subscribe | PRODUCT NAME: PASIREOTIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN OF EEN HYDRAAT DAARVAN; REGISTRATION NO/DATE: EU/1/12/753 20141119 | ||||||||||||||||||||||||||
| 90022-1 | Sweden | ► Subscribe | PRODUCT NAME: PASIREOTID; REG. NO/DATE: EU/1/12/753/001 20120424 | ||||||||||||||||||||||||||
| 2012 00024 | Denmark | ► Subscribe | PRODUCT NAME: PASIREOTID OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER PASIREOTIDDIASPARTAT; REG. NO/DATE: EU/1/12/753/001-012 20120424 | ||||||||||||||||||||||||||
| C/GB12/030 | United Kingdom | ► Subscribe | PRODUCT 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 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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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