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 four 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.
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: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 8 |
Clinical Trials: | 7 |
Patent Applications: | 339 |
Drug Prices: | Drug price information for SIGNIFOR |
What excipients (inactive ingredients) are in SIGNIFOR? | SIGNIFOR excipients list |
DailyMed Link: | SIGNIFOR at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
SIGNIFOR is protected by two US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of SIGNIFOR is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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
Somatostatin analogues
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pharmaceutical composition comprising cyclic somatostatin analogues
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | pasireotide diaspartate | SOLUTION;SUBCUTANEOUS | 200677-001 | Dec 14, 2012 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Recordati Rare | SIGNIFOR LAR KIT | pasireotide pamoate | FOR SUSPENSION;INTRAMUSCULAR | 203255-005 | Jun 29, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Recordati Rare | SIGNIFOR LAR KIT | pasireotide pamoate | FOR SUSPENSION;INTRAMUSCULAR | 203255-003 | Dec 15, 2014 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Recordati Rare | SIGNIFOR LAR KIT | pasireotide pamoate | FOR SUSPENSION;INTRAMUSCULAR | 203255-004 | Jun 29, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Recordati Rare | SIGNIFOR | pasireotide diaspartate | SOLUTION;SUBCUTANEOUS | 200677-002 | Dec 14, 2012 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
>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 | 200677-002 | Dec 14, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
Recordati Rare | SIGNIFOR | pasireotide diaspartate | SOLUTION;SUBCUTANEOUS | 200677-001 | Dec 14, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
Recordati Rare | SIGNIFOR | pasireotide diaspartate | SOLUTION;SUBCUTANEOUS | 200677-003 | Dec 14, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SIGNIFOR
See the table below for patents covering SIGNIFOR around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Africa | 9605538 | ⤷ Try a Trial | |
South Africa | 200509741 | Pharmaceutical composition comprising cyclic smatostin analogues | ⤷ Try a Trial |
South Korea | 20060030052 | PHARMACEUTICAL COMPOSITION | ⤷ Try a Trial |
South Korea | 100799394 | ⤷ Try a Trial | |
Japan | 2003104998 | SOMATOSTATIN PEPTIDE | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SIGNIFOR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1307486 | C 2012 018 | Romania | ⤷ Try a Trial | PRODUCT NAME: PASIREOTIDA SI SARURILE ACCEPTABILE FARMACEUTIC ALEACESTEIACICLO[(4R)-4-(2-AMINOETILCARBAMOILOXI)-L-PROLIL-L-FENILGLICIL-D-TRIPTOFIL-L-LISIL-4-O-BENZIL-L-TIROSIL-L-FENILALANIL-); NATIONAL AUTHORISATION NUMBER: RO EU/1/12/753/001 - RO EU/1/12/753/012; DATE OF NATIONAL AUTHORISATION: 20120424; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/12/753/001 - EMEA EU/1/12/753/012; DATE OF FIRST AUTHORISATION IN EEA: 20120424 |
1307486 | 92024 | Luxembourg | ⤷ Try a Trial | 92024, EXPIRES: 20260730 |
1686964 | C300716 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: PASIREOTIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN OF EEN HYDRAAT DAARVAN; REGISTRATION NO/DATE: EU/1/12/753 20141119 |
1307486 | C01307486/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: PASIREOTID; REGISTRATION NO/DATE: SWISSMEDIC 61254 02.11.2012 |
1307486 | 2012C/026 | Belgium | ⤷ Try a Trial | 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 |