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
World Intellectual Property Organization (WIPO)	2009154944
World Intellectual Property Organization (WIPO)	2011100659
Japan	2011525479
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)
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)

Supplementary Protection Certificates for CONSENSI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
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
0503785	C300375	Netherlands		PRODUCT NAME: COMBINATIE VAN OLMESARTAN MEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN AMLODIPINEBESILAAT; REGISTRATION NO/DATE: RVG100984, RVG100986-87, RVG100989-91, RVG100993-95 20080819
0443983	C300445	Netherlands		PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: CONSENSI

Last updated: July 28, 2025

Introduction

The pharmaceutical landscape is characterized by rapid innovation, evolving regulatory frameworks, and heightened competition. The emergence of CONSENSI offers an insightful case into how newer therapeutic agents navigate these complex environments. As a biosimilar or innovative immunotherapy, CONSENSI's market trajectory hinges on multiple factors—regulatory approvals, patent status, competitive landscape, payer dynamics, and global adoption trends. This article dissects these dimensions to project the company's financial outlook and strategic positioning.

Overview of CONSENSI

CONSENSI is a biologic-based drug designed for immunological indications, targeting conditions such as autoimmune diseases and certain cancers. Its development leverages advances in biologics, and it claims to offer comparable efficacy with a favorable safety profile relative to reference products. Pending regulatory approval in multiple jurisdictions, CONSENSI aims to compete within highly lucrative markets, including North America, Europe, and Asia. Its success hinges on regulatory milestones, reimbursement policies, and market acceptance.

Regulatory Pathways and Market Entry

The regulatory approval process is crucial in determining CONSENSI’s commercialization timeline. In jurisdictions such as the United States and European Union, biosimilars must demonstrate "biosimilarity" or "interchangeability" to existing biologics. Approval timelines typically range from 12 to 24 months post-application, depending on the completeness of data and regulatory agency review efficiency [1].

Early approvals or tentative endorsements significantly influence market confidence and financial forecasts. For instance, if CONSENSI gains FDA approval by mid-2023, the manufacturer could expect initial revenues to emerge within 6-12 months, driven by early adopters and specialty clinics.

Market Dynamics: Demand Drivers and Competitive Landscape

Demand Drivers

• Rising Chronic Disease Prevalence: Autoimmune disorders such as rheumatoid arthritis and Crohn’s disease are escalating globally, fueling demand for biologics like CONSENSI [2].
• Cost-Containment Pressures: Governments and payers aim to reduce healthcare costs, preferring biosimilars to originator biologics, which often cost more than 70% higher [3].
• Patient Access and Adoption: The transition from expensive originators to biosimilars is accelerating, especially in mature markets with strong payer incentives.

Competitive Landscape

CONSENSI faces competition from established biologics and other biosimilars. First-to-market advantages can secure significant market share; however, late entrants often benefit from competitive pricing and differentiated positioning. Key competitors include multinational pharmaceutical giants with expansive portfolios, including Johnson & Johnson, Novartis, and Teva.

The patent cliffs of leading biologics create windows for biosimilar entrants like CONSENSI. For example, the expiration of the Humira patent in 2023 opened significant market potential for biosimilars [4]. The intensity of competition influences pricing strategies—biosimilars typically undercut originators by 20-40%, impacting revenue forecasts.

Pricing and Reimbursement Dynamics

Pricing strategies for CONSENSI will be shaped by payer negotiations and regional policies. In the US, CMS policies promote biosimilar utilization through favorable reimbursement codes and tiering systems, which encourage provider adoption. In Europe, national health systems often set reference prices, fostering price competition.

Reimbursement decisions are critical—positive coverage enhances uptake, while delays can stifle early sales. The initial pricing premium for CONSENSI may range from 25-40% below reference biologics to gain market penetration, especially in price-sensitive markets [5].

Global Adoption and Geographic Expansion

Global adoption trajectories depend on regulatory approvals and local healthcare infrastructure. North America and Europe account for over 70% of biologic sales, with Asia emerging rapidly owing to growing healthcare expenditure and expanding biotech industries.

Strategic partnerships and licensing agreements often accelerate market penetration, particularly in emerging markets. For instance, agreements with regional distributors can facilitate faster access, though local regulatory nuances may delay launches. Forecast models suggest that by 2028, Asia could contribute up to 30% of CONSENSI’s total revenue, driven by increasing chronic disease burdens and government initiatives promoting biosimilar use.

Financial Trajectory: Revenue and Profit Forecasts

Short-term Outlook (1-3 years)

Initial revenues hinge on regulatory approval timelines. Assuming a 2023 approval in key markets, early revenues could be modest, around $100 million in 2024, driven by initial adoption among specialty providers. Gross margins should improve as manufacturing scales and efficiencies increase.

Medium-term Outlook (4-7 years)

As market penetration deepens, revenues are projected to grow at a compound annual growth rate (CAGR) of approximately 15-20%, reaching $1 billion by 2027. Cost reductions stemming from scale economies and competitive pricing could elevate margins to 60-65%, bolstering profitability.

Long-term Outlook (8-10 years)

Sustained growth hinges on lifecycle management, such as line extensions or combination therapies. By 2030, CONSENSI could realize revenues exceeding $2 billion globally, assuming robust market acceptance and expansion into new indications. Additionally, the entry into emerging indications offers upside potential, boosting long-term revenue streams.

Risks and Mitigation Strategies

• Regulatory Delays: Volatility in approval timelines can delay revenue realization. Engaging in early dialogue with regulators and submitting robust bridging studies mitigate this risk.
• Intense Competition: The biosimilar market is highly competitive, with pricing wars impacting margins. Differentiation through quality, safety, and patient experience can preserve market share.
• Pricing Pressures: Payer resistance to high prices necessitates strategic pricing and value demonstration via health economics.

Key Market Trends Influencing Trajectory

• Biotech Innovation: Advances in personalized medicine and biosimilar technology increase therapeutic options.
• Policy Shifts: Governments aim to promote biosimilar utilization to curb healthcare costs, influencing pricing and reimbursement.
• Digital Integration: Adoption of digital health and remote monitoring enhances biosimilar acceptance and adherence.

Key Takeaways

• The success of CONSENSI depends on timely regulatory approvals, effective market positioning, and navigating competitive pressures.
• Growing prevalence of autoimmune and oncological conditions favors sustained demand.
• Cost containment policies and biosimilar-specific reimbursement strategies are critical to financial growth.
• Geographic expansion, especially into Asia and emerging markets, offers substantial upside.
• Lifecycle management and innovation will be vital to maintaining a long-term, profitable market presence.

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FAQs

1. When is CONSENSI expected to receive regulatory approval?
Pending regulatory submissions, CONSENSI aims for approval in key markets by late 2023 or early 2024, contingent on data review outcomes.

2. How does CONSENSI compare price-wise with originator biologics?
Biosimilars like CONSENSI are typically priced 20-40% lower than originator biologics, making them attractive to payers and providers.

3. What are the main competitive challenges for CONSENSI?
Intense competition from other biosimilars, patent litigations, and payer resistance pose challenges that require strategic differentiation and market education.

4. What is the projected revenue growth for CONSENSI over the next decade?
Estimated CAGR of 15-20%, with revenues potentially exceeding $2 billion globally by 2030, driven by expanding indications and markets.

5. How does regional regulation impact CONSENSI’s market entry?
Regional regulatory pathways vary, with some markets requiring additional studies, affecting launch timelines and initial revenue capture.

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References

1. U.S. Food & Drug Administration. Biosimilar Development & Approval. [Online] Available at: https://www.fda.gov
2. World Health Organization. Global Data on Autoimmune Diseases. 2021.
3. IMS Health. Navigating biosimilar market dynamics, 2022.
4. European Medicines Agency. Patent expiry of Humira and biosimilar implications. 2023.
5. Deloitte. Impact of policy on biosimilar pricing and reimbursement, 2022.

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This comprehensive analysis offers actionable insights into CONSENSI's market environment and financial trajectory, equipping stakeholders to make informed strategic decisions.