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Last Updated: February 24, 2020

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CONSENSI Drug Profile


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When do Consensi patents expire, and what generic alternatives are available?

Consensi is a drug marketed by Coeptis and is included in one NDA. There are two patents protecting this drug.

This drug has eight patent family members in six countries.

The generic ingredient in CONSENSI is amlodipine besylate; celecoxib. There are fifty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amlodipine besylate; celecoxib profile page.

US ANDA Litigation and Generic Entry Outlook for Consensi

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 31, 2021. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for CONSENSI
International Patents:8
US Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Formulation / Manufacturing:see details
DailyMed Link:CONSENSI at DailyMed
Drug patent expirations by year for CONSENSI
Generic Entry Opportunity Date for CONSENSI
Generic Entry Date for CONSENSI*:
Constraining patent/regulatory exclusivity:
NEW COMBINATION
NDA:
Dosage:
TABLET;ORAL

*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.

US Patents and Regulatory Information for CONSENSI

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Coeptis CONSENSI amlodipine besylate; celecoxib TABLET;ORAL 210045-001 May 31, 2018 RX Yes No   Start Trial   Start Trial Y   Start Trial
Coeptis CONSENSI amlodipine besylate; celecoxib TABLET;ORAL 210045-003 May 31, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Coeptis CONSENSI amlodipine besylate; celecoxib TABLET;ORAL 210045-002 May 31, 2018 RX Yes No   Start Trial   Start Trial Y   Start Trial
Coeptis CONSENSI amlodipine besylate; celecoxib TABLET;ORAL 210045-003 May 31, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Coeptis CONSENSI amlodipine besylate; celecoxib TABLET;ORAL 210045-001 May 31, 2018 RX Yes No   Start Trial   Start Trial Y   Start Trial
Coeptis CONSENSI amlodipine besylate; celecoxib TABLET;ORAL 210045-001 May 31, 2018 RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for CONSENSI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1507558 12C0033 France   Start Trial PRODUCT NAME: ALISKIRENE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE E CELUI-CI, AMLODIPINE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, ET HYDROCHLOROTHIAZIDE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 20111122; FIRST REGISTRATION: 6167801 20110705
1915993 92315 Luxembourg   Start Trial PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
0503785 C300486 Netherlands   Start Trial PRODUCT NAME: COMBINATIE VAN OLMESARTANMEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, AMLODIPINEBESYLAAT AND HYDROCHLOORTHIAZIDE; NATL REGISTRATION NO/DATE: RVG 106667, RVG 106671-74, RVG 106682-86 20101221; FIRST REGISTRATION: DE 79810.00.00-79814.00.00 20101216
1915993 C300625 Netherlands   Start Trial PRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414
0443983 C00443983/03 Switzerland   Start Trial PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
1915993 300625 Netherlands   Start Trial PRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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