SIGNIFOR LAR KIT Drug Patent Profile
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Which patents cover Signifor Lar Kit, and what generic alternatives are available?
Signifor Lar Kit is a drug marketed by Recordati Rare and is included in one NDA. There are three patents protecting this drug.
This drug has one hundred and thirty-five patent family members in fifty-three countries.
The generic ingredient in SIGNIFOR LAR KIT 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 Lar Kit
Signifor Lar Kit 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 May 23, 2028. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Summary for SIGNIFOR LAR KIT
International Patents: | 135 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 7 |
DailyMed Link: | SIGNIFOR LAR KIT at DailyMed |
![SIGNIFOR LAR KIT drug patent expirations Drug patent expirations by year for SIGNIFOR LAR KIT](/p/graph/s/t/SIGNIFOR_LAR_KIT-patent-expirations.png)
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for SIGNIFOR LAR KIT
Generic Entry Date for SIGNIFOR LAR KIT*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
FOR SUSPENSION;INTRAMUSCULAR |
*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 LAR KIT
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 |
US Patents and Regulatory Information for SIGNIFOR LAR KIT
SIGNIFOR LAR KIT is protected by three US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of SIGNIFOR LAR KIT is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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 LAR KIT
Somatostatin analogues
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Microparticles comprising somatostatin analogues
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Extended-release composition comprising a somatostatin derivative in microparticles
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting SIGNIFOR LAR KIT
INDICATED FOR TREATMENT OF PATIENTS WITH CUSHING'S DISEASE FOR WHOM PITUITARY SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE
Exclusivity Expiration: ⤷ Sign Up
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 | 203255-004 | Jun 29, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Recordati Rare | SIGNIFOR LAR KIT | pasireotide pamoate | FOR SUSPENSION;INTRAMUSCULAR | 203255-003 | Dec 15, 2014 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Recordati Rare | SIGNIFOR LAR KIT | pasireotide pamoate | FOR SUSPENSION;INTRAMUSCULAR | 203255-001 | Dec 15, 2014 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Recordati Rare | SIGNIFOR LAR KIT | pasireotide pamoate | FOR SUSPENSION;INTRAMUSCULAR | 203255-004 | Jun 29, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Recordati Rare | SIGNIFOR LAR KIT | pasireotide pamoate | FOR SUSPENSION;INTRAMUSCULAR | 203255-005 | Jun 29, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 LAR KIT
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Recordati Rare | SIGNIFOR LAR KIT | pasireotide pamoate | FOR SUSPENSION;INTRAMUSCULAR | 203255-003 | Dec 15, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Recordati Rare | SIGNIFOR LAR KIT | pasireotide pamoate | FOR SUSPENSION;INTRAMUSCULAR | 203255-001 | Dec 15, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Recordati Rare | SIGNIFOR LAR KIT | pasireotide pamoate | FOR SUSPENSION;INTRAMUSCULAR | 203255-003 | Dec 15, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Recordati Rare | SIGNIFOR LAR KIT | pasireotide pamoate | FOR SUSPENSION;INTRAMUSCULAR | 203255-002 | Dec 15, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Recordati Rare | SIGNIFOR LAR KIT | pasireotide pamoate | FOR SUSPENSION;INTRAMUSCULAR | 203255-001 | Dec 15, 2014 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SIGNIFOR LAR KIT
See the table below for patents covering SIGNIFOR LAR KIT around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Ecuador | SP066565 | MICROPARTÍCULAS QUE COMPRENDEN ANÁLOGOS DE SOMATOSTATINA | ⤷ Sign Up |
Austria | 393782 | ⤷ Sign Up | |
Austria | 210152 | ⤷ Sign Up | |
Tunisia | SN06136 | MICROPARTICLES COMPRISING SOMATOSTATIN ANALOGUES | ⤷ Sign Up |
Mexico | 9709962 | PEPTIDOS DE SOMATOSTATINA. (SOMATOSTATIN PEPTIDES.) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SIGNIFOR LAR KIT
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1307486 | 12C0041 | France | ⤷ Sign Up | 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 |
1686964 | PA2015009 | Lithuania | ⤷ Sign Up | PRODUCT NAME: PASIREOTIDUM; REGISTRATION NO/DATE: EU/1/12/753/13 - EU/1/12/753/17 20141119 |
1307486 | 122012000045 | Germany | ⤷ Sign Up | PRODUCT NAME: PASIREOTID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON ODER EIN KOMPLEX HIERVON; REGISTRATION NO/DATE: EU/1/12/753/001-012 20120424 |
1307486 | 418 | Finland | ⤷ Sign Up | |
1307486 | 1290022-1 | Sweden | ⤷ Sign Up | PRODUCT NAME: PASIREOTID; REG. NO/DATE: EU/1/12/753/001 20120424 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |