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SIGNIFOR Drug Patent Profile
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Which patents cover Signifor, and what generic alternatives are available?
Signifor is a drug marketed by Recordati Rare and is included in two NDAs. There are five patents protecting this drug.
This drug has eighty-seven patent family members in thirty-nine countries.
The generic ingredient in SIGNIFOR 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
Signifor 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 December 14, 2026. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for SIGNIFOR
| International Patents: | 87 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 20 |
| Clinical Trials: | 7 |
| Patent Applications: | 611 |
| Drug Prices: | Drug price information for SIGNIFOR |
| What excipients (inactive ingredients) are in SIGNIFOR? | SIGNIFOR excipients list |
| DailyMed Link: | SIGNIFOR at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for SIGNIFOR
Generic Entry Date for SIGNIFOR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;SUBCUTANEOUS |
*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
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Colorado, Denver | Phase 1 |
| Hospices Civils de Lyon | Phase 2 |
| Zealand University Hospital | Phase 4 |
Pharmacology for SIGNIFOR
| Drug Class | Somatostatin Analog |
| Mechanism of Action | Somatostatin Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for SIGNIFOR
US Patents and Regulatory Information for SIGNIFOR
| 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 | 203255-003 | Dec 15, 2014 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | Y | ⤷ Try it Free | |||
| Recordati Rare | SIGNIFOR LAR KIT | pasireotide pamoate | FOR SUSPENSION;INTRAMUSCULAR | 203255-002 | Dec 15, 2014 | RX | Yes | No | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Recordati Rare | SIGNIFOR LAR KIT | pasireotide pamoate | FOR SUSPENSION;INTRAMUSCULAR | 203255-003 | Dec 15, 2014 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | Y | ⤷ Try it Free | |||
| >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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Recordati Rare | SIGNIFOR | pasireotide diaspartate | SOLUTION;SUBCUTANEOUS | 200677-001 | Dec 14, 2012 | ⤷ Try it Free | ⤷ Try it Free |
| Recordati Rare | SIGNIFOR | pasireotide diaspartate | SOLUTION;SUBCUTANEOUS | 200677-003 | Dec 14, 2012 | ⤷ Try it Free | ⤷ Try it Free |
| Recordati Rare | SIGNIFOR | pasireotide diaspartate | SOLUTION;SUBCUTANEOUS | 200677-002 | Dec 14, 2012 | ⤷ Try it Free | ⤷ Try it Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SIGNIFOR
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Taiwan | I361194 | ⤷ Try it Free |
| China | 1267451 | ⤷ Try it Free |
| Israel | 122243 | ⤷ Try it Free |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for SIGNIFOR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1307486 | 12C0041 | France | ⤷ Try it Free | PRODUCT 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 |
| 1307486 | 122012000045 | Germany | ⤷ Try it Free | PRODUCT NAME: PASIREOTID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON ODER EIN KOMPLEX HIERVON; REGISTRATION NO/DATE: EU/1/12/753/001-012 20120424 |
| 1307486 | SPC/GB12/030 | United Kingdom | ⤷ Try it Free | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
