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
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 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.

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

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
Australia	2009260632	Pharmaceutical formulations and methods of use which combine non-steroidal anti-inflammatory compounds with anti-hypertensive compounds
China	111065382	塞来昔布和氨氯地平的配方及其制备方法 (CELECOXIB AND AMLODIPINE FORMULATION AND METHOD OF MAKING THE SAME)
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)
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.)
World Intellectual Property Organization (WIPO)	2011100659
World Intellectual Property Organization (WIPO)	2009154944

Supplementary Protection Certificates for CONSENSI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1507558	12C0033	France		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: CH - 6167801 20110705
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
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
1507558	C300528	Netherlands		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
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

Market Dynamics and Financial Trajectory for the Drug: Consensi

Introduction

Consensi, a combination drug of amlodipine and celecoxib, was approved by the FDA on May 31, 2018, for the treatment of hypertension and pain associated with osteoarthritis. Despite its innovative formulation, the drug's market performance and financial trajectory have been marked by significant challenges.

FDA Approval and Initial Market Entry

Consensi was developed by Kitov Pharmaceuticals, later known as Purple Biotech Ltd., and represented a unique combination of a calcium channel blocker (amlodipine) and a nonsteroidal anti-inflammatory drug (celecoxib)[1].

Commercialization Challenges

From the outset, Consensi faced substantial commercialization hurdles. The drug's entry into the market was anticipated to be competitive, given the established presence of both amlodipine and celecoxib as standalone treatments.

Termination of Distribution Agreement

A critical turning point came on February 9, 2022, when Purple Biotech Ltd. announced the termination of the agreement with the U.S. distributor for Consensi. This decision was driven by the conclusion that commercialization of Consensi was unlikely to generate significant revenue or achieve profitability in the near term[1].

Discontinuation of Consensi

As a result of the financial projections, Purple Biotech Ltd. decided to discontinue Consensi to reduce the expenses associated with maintaining the product. The marketing end date for Consensi was set for July 27, 2022[1].

Revenue and Profitability Issues

The failure of Consensi to achieve profitability highlights broader issues within the pharmaceutical industry. For branded prescription drugs, manufacturers typically capture a significant portion of the revenue, with approximately $76 out of every $100 spent going to the manufacturers. However, this does not necessarily translate to profitability for every drug, especially those with limited market demand or intense competition[2].

Market Concentration and Pricing

The pharmaceutical supply chain is highly concentrated, with top players dominating significant market shares. This concentration can lead to higher consumer prices and complex pricing dynamics. For Consensi, navigating this landscape proved challenging, particularly in a market where generic alternatives and established brand names already held strong positions[2].

Economic Implications of Drug Development

The development and pricing of pharmaceuticals are influenced by various economic factors, including the cost of research and development (R&D), the size of the target patient population, and the presence of government incentives. For Consensi, the combination of amlodipine and celecoxib did not generate enough value to justify the R&D investments and ongoing costs associated with its maintenance[3].

Role of Pharmacy Benefit Managers (PBMs) and Insurers

Pharmacy benefit managers and insurers play a crucial role in the pharmaceutical supply chain, negotiating prices and influencing the profitability of drugs. However, their large market power can sometimes result in higher profits for these intermediaries rather than lower prices for consumers. In the case of Consensi, the lack of favorable negotiations with PBMs and insurers may have further exacerbated its commercial challenges[2].

Consumer Impact

The discontinuation of Consensi affects patients who were relying on this specific combination therapy for their hypertension and osteoarthritis. This highlights the broader issue of drug accessibility and affordability, where patients often bear the brunt of market dynamics and financial decisions made by pharmaceutical companies.

Lessons Learned

The story of Consensi serves as a cautionary tale for pharmaceutical companies. It underscores the importance of thorough market analysis, robust financial planning, and strategic partnerships in the highly competitive and regulated pharmaceutical industry.

Future Outlook

For drugs like Consensi, the future hinges on the ability to demonstrate significant clinical value and economic viability. This involves not only meeting regulatory requirements but also navigating the complex web of market forces, including pricing negotiations and supply chain dynamics.

Key Takeaways

• Commercialization Challenges: Consensi faced significant commercialization hurdles, leading to its discontinuation.
• Financial Projections: The drug was not expected to generate significant revenue or achieve profitability.
• Market Concentration: The pharmaceutical supply chain is highly concentrated, affecting pricing and profitability.
• Economic Factors: R&D costs, patient population size, and government incentives influence drug development and pricing.
• Role of PBMs and Insurers: These intermediaries play a crucial role in negotiating prices and influencing drug profitability.

FAQs

What is Consensi, and what is it used for?

Consensi is a combination drug of amlodipine and celecoxib, approved for the treatment of hypertension and pain associated with osteoarthritis.

Why was Consensi discontinued?

Consensi was discontinued due to the conclusion that its commercialization was unlikely to generate significant revenue or achieve profitability in the near term.

What role did market concentration play in Consensi's failure?

Market concentration in the pharmaceutical supply chain, particularly among PBMs and wholesalers, can lead to higher consumer prices and complex pricing dynamics, which contributed to Consensi's commercial challenges.

How do PBMs and insurers influence drug profitability?

PBMs and insurers negotiate prices with manufacturers, and their large market power can result in higher profits for these intermediaries rather than lower prices for consumers.

What are the broader implications of Consensi's discontinuation for patients?

The discontinuation of Consensi affects patients relying on this specific combination therapy, highlighting broader issues of drug accessibility and affordability in the pharmaceutical market.

Sources

1. Drugs.com - Consensi (amlodipine and celecoxib) FDA Approval History
2. HealthPolicy.USC.edu - Follow the Money to Understand How Drug Profits Flow
3. NBER.org - The Economics of Drug Development: Pricing and Innovation in a Changing Market