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 is one patent protecting this drug and one Paragraph IV challenge.

This drug has two patent family members in two 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 June 14, 2038. 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:	2
US Patents:	1
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

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

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 one 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.

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

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:

China

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
China	111065382
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
Canada	2726337	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)
European Patent Office	2285371	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)
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	C300445	Netherlands		PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
0443983	C00443983/03	Switzerland		PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
0443983	2007C/043	Belgium		PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
0502314	C300478	Netherlands		PRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN AMLODIPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER AMLODIPINEBESILAAT; REGISTRATION NO/DATE: EU/1/10/648/001-028 20101007
0502314	SPC/GB11/010	United Kingdom		PRODUCT NAME: THE COMBINATION OF A) TELMISARTAN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, AND B) AMLODIPINE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, ESPECIALLY AMLODIPINE BESYLATE; REGISTERED: UK EU/1/10/648/001 20101007; UK EU/1/10/648/002 20101007; UK EU/1/10/648/003 20101007; UK EU/1/10/648/004 20101007; UK EU/1/10/648/005 20101007; UK EU/1/10/648/006 20101007; UK EU/1/10/648/007 20101007; UK EU/1/10/648/008 20101007; UK EU/1/10/648/009 20101007; UK EU/1/10/648/010 20101007; UK EU/1/10/648/011 20101007; UK EU/1/10/648/012 20101007; UK EU/1/10/648/013 20101007; UK EU/1/10/648/014 20101007; UK EU/1/10/648/015 20101007; UK EU/1/10/648/016 20101007; UK
0503785	C300486	Netherlands		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
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

Consensi (consensi) market dynamics and financial trajectory: sales trends, payer positioning, exclusivity, and competitive risk

Last updated: May 28, 2026

Consensi is not identifiable as a specific FDA-approved pharmaceutical product or as a clearly documented active ingredient in the available reference context. Without a verifiable drug identity (INN/active ingredient, dosage form, NDA/BLA number, manufacturer, and launch/market start), market sizing, payer dynamics, exclusivity timing, and financial trajectory cannot be produced accurately.

What is Consensi and what active ingredient does it use?

Featured snippet answer: Not determinable from the provided input.

Which drug identity is “Consensi” in FDA and payer systems?

Featured snippet answer: Not determinable from the provided input.

• No mapped NDA/BLA or INN match can be tied to the term “consensi” from the information available.

How did Consensi sales perform after launch?

Featured snippet answer: Not determinable from the provided input.

What reported revenue series exist (quarterly/annual) for Consensi?

Featured snippet answer: Not determinable from the provided input.

• No verifiable financial statements, segment reporting line items, or analyst consensus can be linked to “Consensi” without the product identity.

What share trends and unit economics drive the financial trajectory?

Featured snippet answer: Not determinable from the provided input.

What payer dynamics determine Consensi uptake (formulary, rebates, PA/step edits)?

Featured snippet answer: Not determinable from the provided input.

Is Consensi preferred or restricted on major commercial formularies?

Featured snippet answer: Not determinable from the provided input.

How do Medicare Part D and Medicaid coverage patterns affect net sales?

Featured snippet answer: Not determinable from the provided input.

When does Consensi lose exclusivity and what does that mean for the revenue curve?

Featured snippet answer: Not determinable from the provided input.

What patent and exclusivity timelines apply (Orange Book, Hatch-Waxman, 5-year/3-year/marketing exclusivity)?

Featured snippet answer: Not determinable from the provided input.

What is the generic or biosimilar entry risk window?

Featured snippet answer: Not determinable from the provided input.

What patents protect Consensi, and how strong is the estate versus generic challengers?

Featured snippet answer: Not determinable from the provided input.

How many Orange Book listings cover the product?

Featured snippet answer: Not determinable from the provided input.

What patent types matter most for commercial leverage (formulation, device, method-of-use, polymorph)?

Featured snippet answer: Not determinable from the provided input.

What patent litigation or settlements affect Consensi market access?

Featured snippet answer: Not determinable from the provided input.

Have any Paragraph IV certifications been filed?

Featured snippet answer: Not determinable from the provided input.

What do any settlements imply for launch timing?

Featured snippet answer: Not determinable from the provided input.

What regulatory pathway and FDA status govern Consensi commercialization?

Featured snippet answer: Not determinable from the provided input.

What is the FDA approval history (application type, approval date, label updates)?

Featured snippet answer: Not determinable from the provided input.

What is the Orange Book status of Consensi?

Featured snippet answer: Not determinable from the provided input.

How does Consensi compare with competing therapies for the same indication?

Featured snippet answer: Not determinable from the provided input.

What is the competitive set and how do mechanism and route compare?

Featured snippet answer: Not determinable from the provided input.

How do switching dynamics (payer preference, clinical guidelines) shape demand?

Featured snippet answer: Not determinable from the provided input.

Key Takeaways

• Consensi’s market dynamics and financial trajectory cannot be analyzed without a verifiable drug identity tied to an active ingredient, FDA application, and Orange Book listing.
• No reliable conclusions can be produced on sales performance, payer positioning, exclusivity timing, patent strength, or competitive entry risk from the provided input alone.

FAQs

1. What is the FDA approval status of Consensi?
2. What is the Orange Book listing count for Consensi, and when do key patents expire?
3. Are there any Paragraph IV challenges to Consensi?
4. Which competitors have the closest comparable efficacy and dosing to Consensi?
5. What payer restrictions (prior authorization, step therapy) apply to Consensi?

References

1. None.