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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. One supplier is listed for this compound. Additional details are available on the pasireotide pamoate profile page.
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
|Finished Product Suppliers / Packagers:||1|
|Raw Ingredient (Bulk) Api Vendors:||6|
|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
*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
|University of Colorado, Denver||Phase 1|
|Hospices Civils de Lyon||Phase 2|
|Zealand University Hospital||Phase 4|
Pharmacology for SIGNIFOR
SIGNIFOR is protected by two US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of SIGNIFOR is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting SIGNIFOR
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||Patent No.||Patent Expiration|
|Recordati Rare||SIGNIFOR||pasireotide diaspartate||SOLUTION;SUBCUTANEOUS||200677-003||Dec 14, 2012||See Plans and Pricing||See Plans and Pricing|
|Recordati Rare||SIGNIFOR||pasireotide diaspartate||SOLUTION;SUBCUTANEOUS||200677-001||Dec 14, 2012||See Plans and Pricing||See Plans and Pricing|
|Recordati Rare||SIGNIFOR||pasireotide diaspartate||SOLUTION;SUBCUTANEOUS||200677-002||Dec 14, 2012||See Plans and Pricing||See Plans and Pricing|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>Patent No.||>Patent Expiration|
See the table below for patents covering SIGNIFOR around the world.
|Country||Patent Number||Title||Estimated Expiration|
|Luxembourg||92024||See Plans and Pricing|
|Spain||2305104||See Plans and Pricing|
|Ecuador||SP034456||ANALOGOS DE SOMATOSTATINA||See Plans and Pricing|
|Russian Federation||2287533||АНАЛОГИ СОМАТОСТАТИНА (SOMATOSTATIN ANALOGUES)||See Plans and Pricing|
|South Korea||20030033008||See Plans and Pricing|
|China||1156492||See Plans and Pricing|
|Norway||330706||See Plans and Pricing|
|>Country||>Patent Number||>Title||>Estimated Expiration|
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|1307486||418||Finland||See Plans and Pricing|
|1307486||CA 2012 00024||Denmark||See Plans and Pricing|
|1648934||C20120019 00062||Estonia||See Plans and Pricing||PRODUCT NAME: SIGNIFOR-PASIREOTIID;REG NO/DATE: C(2012) 2910 FINAL 24.04.2012|
|1307486||2012/027||Ireland||See Plans and Pricing||PRODUCT NAME: PASIREOTIDE OR A SALT OR COMPLEX THEREOF; REGISTRATION NO/DATE: EU/1/12/753/001-EU/1/12/753/012 20120424|
|1307486||132012902062571||Italy||See Plans and Pricing||PRODUCT NAME: PASIREOTIDE DIASPARTATO(SIGNIFOR); AUTHORISATION NUMBER(S) AND DATE(S): EU71/12/753/001-012, 20120424|
|1307486||C300536||Netherlands||See Plans and Pricing||PRODUCT NAME: PASIREOTIDE, DESGEWENST IN DE VORM VAN EEN ZOUT, IN HET BIJZONDER PASIREOTIDEDI-ASPARTAAT; REGISTRATION NO/DATE: EU/1/12/753/001-012 20120424|
|1307486||2012C/026||Belgium||See Plans and Pricing||PRODUCT NAME: PASIREOTIDE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/12/753/001 20120426|
|>Patent Number||>Supplementary Protection Certificate||>SPC Country||>SPC Expiration||>SPC Description|