CONSENSI Drug Patent Profile

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Which patents cover Consensi, and when can generic versions of Consensi launch?

Consensi is a drug marketed by Purple Biotech and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has nine patent family members in seven countries.

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

DrugPatentWatch^® Generic Entry Outlook for Consensi

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 22, 2029. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Summary for CONSENSI

International Patents:	9
US Patents:	5
Applicants:	1
NDAs:	1
Clinical Trials:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CONSENSI
What excipients (inactive ingredients) are in CONSENSI?	CONSENSI excipients list
DailyMed Link:	CONSENSI at DailyMed

Drug patent expirations by year for CONSENSI

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for CONSENSI

Generic Entry Date for CONSENSI^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 210045 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.

Recent Clinical Trials for CONSENSI

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Kitov Pharma Ltd	Phase 3
Kitov Pharmaceuticals, Ltd.	Phase 3

See all CONSENSI clinical trials

Paragraph IV (Patent) Challenges for CONSENSI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CONSENSI	Tablets	amlodipine besylate; celecoxib	2.5 mg/200 mg, 5 mg/200 mg, 10 mg/200 mg	210045	1	2020-06-29

US Patents and Regulatory Information for CONSENSI

CONSENSI is protected by five US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of CONSENSI 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 CONSENSI

Celecoxib and amlodipine formulation and method of making the same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Celecoxib and amlodipine formulation and method of making the same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS FOR WHOM TREATMENT WITH BOTH AMLODIPINE FOR HYPERTENSION AND CELECOXIB FOR OSTEOARTHRITIS ARE APPROPRIATE

Celecoxib and amlodipine formulation and method of making the same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Ameliorating drug-induced elevations in blood pressure by adjunctive use of antihypertensive drugs
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS FOR WHOM TREATMENT WITH BOTH AMLODIPINE FOR HYPERTENSION AND CELECOXIB FOR OSTEOARTHRITIS ARE APPROPRIATE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Purple Biotech	CONSENSI	amlodipine besylate; celecoxib	TABLET;ORAL	210045-001	May 31, 2018		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Purple Biotech	CONSENSI	amlodipine besylate; celecoxib	TABLET;ORAL	210045-002	May 31, 2018		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Purple Biotech	CONSENSI	amlodipine besylate; celecoxib	TABLET;ORAL	210045-001	May 31, 2018		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Purple Biotech	CONSENSI	amlodipine besylate; celecoxib	TABLET;ORAL	210045-003	May 31, 2018		DISCN	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

International Patents for CONSENSI

When does loss-of-exclusivity occur for CONSENSI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 09260632
Patent: Pharmaceutical formulations and methods of use which combine non-steroidal anti-inflammatory compounds with anti-hypertensive compounds
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 26337
Patent: FORMULATIONS PHARMACEUTIQUES ET PROCEDES D'UTILISATION COMBINANT DES COMPOSES ANTIINFLAMMATOIRES NON STEROIDES ET DES COMPOSES ANTI-HYPERTENSIFS (PHARMACEUTICAL FORMULATIONS AND METHODS OF USE WHICH COMBINE NON-STEROIDAL ANTI-INFLAMMATORY COMPOUNDS WITH ANTI-HYPERTENSIVE COMPOUNDS)
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 85371
Patent: FORMULATIONS PHARMACEUTIQUES ET PROCÉDÉS D'UTILISATION COMBINANT DES COMPOSÉS ANTIINFLAMMATOIRES NON STÉROÏDES ET DES COMPOSÉS ANTI-HYPERTENSIFS (PHARMACEUTICAL FORMULATIONS AND METHODS OF USE WHICH COMBINE NON-STEROIDAL ANTI-INFLAMMATORY COMPOUNDS WITH ANTI-HYPERTENSIVE COMPOUNDS)
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 11525479
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 10012836
Patent: FORMULACIONES FARMACEUTICAS Y METODOS DE USO QUE COMBINAN COMPUESTOS ANTIINFLAMATORIOS NO ESTEROIDES CON COMPUESTOS ANTIHIPERTENSIVOS. (PHARMACEUTICAL FORMULATIONS AND METHODS OF USE WHICH COMBINE NON-STEROIDAL ANTI-INFLAMMATORY COMPOUNDS WITH ANTI-HYPERTENSIVE COMPOUNDS.)
Estimated Expiration: ⤷ 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.

See the table below for additional patents covering CONSENSI around the world.

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Country	Patent Number	Title	Estimated Expiration
Australia	2009260632	Pharmaceutical formulations and methods of use which combine non-steroidal anti-inflammatory compounds with anti-hypertensive compounds	⤷ Sign Up
Japan	2011525479		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2009154944		⤷ Sign Up
Mexico	2010012836	FORMULACIONES FARMACEUTICAS Y METODOS DE USO QUE COMBINAN COMPUESTOS ANTIINFLAMATORIOS NO ESTEROIDES CON COMPUESTOS ANTIHIPERTENSIVOS. (PHARMACEUTICAL FORMULATIONS AND METHODS OF USE WHICH COMBINE NON-STEROIDAL ANTI-INFLAMMATORY COMPOUNDS WITH ANTI-HYPERTENSIVE COMPOUNDS.)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for CONSENSI

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0503785	CA 2011 00026	Denmark	⤷ Sign Up	PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216
1915993	92315	Luxembourg	⤷ Sign Up	PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
1003503	05C0048	France	⤷ Sign Up	PRODUCT NAME: AMLODIPINE OU UN DE SES SELS D?ADDITION D?ACIDES PHARMACAUTIQUEMENT ACCEPTABLES/ ATORVASTATINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: NL 29929 DU 20050707; REGISTRATION NO/DATE AT EEC: NL 29929 DU 20050707
1507558	C300528	Netherlands	⤷ Sign Up	PRODUCT NAME: COMBINATIE VAN ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; NATL. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description