CONSENSI Drug Patent Profile

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

Summary for CONSENSI

International Patents:	9
US Patents:	5
Applicants:	1
NDAs:	1
Clinical Trials:	2
Formulation / Manufacturing:	see details
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

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

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

Anatomical Therapeutic Chemical (ATC) Classes for CONSENSI

C08CA	Dihydropyridine derivatives
C08C	SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VASCULAR EFFECTS
C08	CALCIUM CHANNEL BLOCKERS
C	Cardiovascular system

L01XX	Other antineoplastic agents
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

M01AH	Coxibs
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

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.

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

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
Purple Biotech	CONSENSI	amlodipine besylate; celecoxib	TABLET;ORAL	210045-002	May 31, 2018		DISCN	Yes	No
Purple Biotech	CONSENSI	amlodipine besylate; celecoxib	TABLET;ORAL	210045-001	May 31, 2018		DISCN	Yes	No			Y
Purple Biotech	CONSENSI	amlodipine besylate; celecoxib	TABLET;ORAL	210045-003	May 31, 2018		DISCN	Yes	No

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

Canada

European Patent Office

Japan

Mexico

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.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2019008583
Australia	2009260632	Pharmaceutical formulations and methods of use which combine non-steroidal anti-inflammatory compounds with anti-hypertensive compounds
Japan	2011525479
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.)

Supplementary Protection Certificates for CONSENSI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0443983	C00443983/03	Switzerland		PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
0503785	CA 2011 00026	Denmark		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
1003503	05C0048	France		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
0678503	C300499	Netherlands		PRODUCT NAME: COMBINATIE OMVATTEND ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110114