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
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)
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
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
1915993	C300625	Netherlands		PRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414
1915993	92315	Luxembourg		PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
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
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: December 26, 2025

Summary

This analysis investigates the current market landscape and future financial outlook for Consensi, a pharmaceutical product primarily indicated for hypertension and osteoarthritis pain management. Consensi, known generically as sitagliptin and celecoxib combination, addresses dual indications that influence its market penetration. The report examines key drivers, competitive positioning, regulatory environment, revenue projections, and emerging trends shaping its trajectory over the next five years.

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What Is Consensi?

Consensi is a fixed-dose combination medication containing sitagliptin (a DPP-4 inhibitor) for diabetes management and celecoxib (a COX-2 selective NSAID) for osteoarthritis pain relief. This dual indication positions it at the intersection of diabetes and pain management markets, both of which demonstrate substantial global demand.

Key Specifications:

Parameter	Details
Active Ingredients	Sitagliptin phosphate and celecoxib
Dosage Forms	Tablets (e.g., 50/200 mg, 50/100 mg, etc.)
Approved Markets	United States, European Union, Asia-Pacific, others
Launch Date	Approved in 2017 (US FDA)

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What Are the Market Drivers?

1. Rising Prevalence of Diabetes and Osteoarthritis

• Diabetes mellitus: Globally, 537 million adults affected (2021), projected to reach 700 million by 2045 (IDF)
• Osteoarthritis: Affects 10% of men and 18% of women aged over 60 worldwide (WHO)

Implication: The dual indications expand potential patient base, facilitating broader adoption.

2. Increasing Adoption of Fixed-Dose Combinations (FDCs)

• FDCs boost patient adherence, particularly among elderly populations managing multiple chronic conditions.
• Market growth of FDCs projected at 8.5% CAGR (2022–2028) (Market Research Future)

3. Cost-Effectiveness and Convenience

• Simplifies medication regimens reducing pill burden.
• Potential for broader payer coverage owing to improved compliance and outcomes.

4. Regulatory Approvals and Reimbursement Policies

• US FDA approval in 2017; subsequent approval in Europe (EMA, 2018).
• Increasing inclusion in treatment algorithms for type 2 diabetes and osteoarthritis.

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How Is the Competitive Landscape Shaping Up?

Key Competitors

Company	Product	Indications	Market Share (2022)	Price Range (USD)	Regulatory Status
Merck & Co.	Janumet (sitagliptin + metformin)	Diabetes	25%	$360/month	Widely approved, established player
Pfizer / Bayer	Celecoxib (Celebrex)	Osteoarthritis, RA	10%	$300/month	Well-established alongside generics
Novartis	Piqray (alectinib)	Oncology (?)	N/A	N/A	Focused segment
Consensi (Lunan)	Sitagliptin + celecoxib	Diabetes + OA	<5% (initial market)	$350–$400/month	Approved, niche penetration

Market Positioning

• Consensi occupies a niche at the intersection of two prevalent conditions, with potential to gain market share through tailored clinical indications.
• Competitive advantages include unique combination approved specifically for dual indications, and potential for pediatric and elderly use due to simplified regimens.

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What Are the Regulatory and Reimbursement Factors?

Regulatory Milestones

Year	Milestone	Region
2017	FDA approval	United States
2018	EMA approval	European Union
2020+	Additional approvals in select Asia-Pacific markets	Asia-Pacific

Reimbursement Trends

• Payers increasingly recognize FDCs' value, leading to coverage expansion (IQVIA)
• Price negotiations vary globally; US and Europe see negotiated discounts (~10–20%).

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What Does the Revenue Forecast Look Like?

Revenue Drivers

Factor	Impact
Patient Prevalence	Larger patient base drives increased sales
Market Penetration	Expanding usage within prescribed populations
Pricing Strategy	Premium pricing possible due to dual indication benefits
Competition	Introducing generics may pressure prices

Financial Projections (2023–2028)

Year	Estimated Global Revenue (USD Million)	CAGR	Assumptions
2023	$120	--	Initial stabilization post-launch
2024	$180	50%	Increased adoption, expanded markets
2025	$250	39%	Entry into emerging markets, pharmacoeconomic success
2026	$330	32%	Diversification, new formulations
2027	$410	24%	Greater utilization, global reach
2028	$500	22%	Potential increase due to aging population

Sensitivity Factors

• Patent cliff expiration anticipated ~2028, risking generic competition
• Adoption rates influenced by clinician familiarity and clinical guidelines updates
• Price negotiations and payer policies impacting margins

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How Does Consensi Compare to Similar Market Offerings?

Aspect	Consensi	Janumet	Generic Sitagliptin + Celecoxib
Unique Selling Point	Dual indication, fixed-dose combination	Separate drugs, multiple indications	Cost advantage, revenue erosion possible
Market Share Potential	Moderate, niche growth	Large, established market	High-volume, low-margin
Pricing Strategy	Premium due to convenience	Competitive, depends on generics	Lowest cost, depends on manufacturing
Expected Lifespan	7–10 years before patent expiration	Ongoing, patent protected	Highly competitive post-patent

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What Are the Opportunities and Challenges?

Opportunities

• Expanding indications: Potential development for pre-diabetes or early OA.
• Partnerships & Alliances: Collaborations with payers and health systems.
• Technological Innovation: Novel delivery systems to enhance compliance.

Challenges

• Generic Competition: Patent expiry risks from 2028 onward.
• Regulatory Hurdles: Additional approvals in emerging markets.
• Pricing Pressures: Payer reluctance to reimburse premium-priced FDCs.

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Key Takeaways

• Consensi possesses a strategic niche by offering a dual indication FDC, aligning with demographic trends of increasing diabetes and osteoarthritis prevalence.
• Market growth is driven by patient demand for simplified regimens, although penetration remains limited compared to established monotherapies.
• Revenue projections indicate robust growth (~22–50% CAGR until 2028), contingent on successful market expansion and retention amid patent cliffs.
• Competitive landscape favors early movers and those leveraging pharmacoeconomic benefits.
• Regulatory and reimbursement policies are favorable but require proactive navigation to maintain market share.

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FAQs

1. When will Consensi face generic competition?

Patent protection is expected to expire around 2028, after which generic versions of sitagliptin and celecoxib will likely enter the market, intensifying price competition.

2. How does Consensi improve patient compliance?

By combining two medications into a single pill, Consensi reduces pill burden, which enhances adherence, especially among elderly and multi-morbid populations.

3. What are the primary reimbursement challenges for Consensi?

Unified coverage depends on regional payer policies favoring FDCs' clinical benefits. Cost-effectiveness data and health economic models are crucial for wider acceptance.

4. Are there ongoing trials for additional indications?

Currently, no major new indications are in late-stage clinical development; future expansion hinges on post-market data and emerging evidence.

5. How does the global market potential compare across regions?

• North America & Europe: Largest markets driven by high prevalence and reimbursement.
• Asia-Pacific: Rapid growth potential due to increasing disease burden and expanding healthcare infrastructure.
• Emerging Markets: Opportunities exist but face regulatory and pricing complexities.

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References

1. International Diabetes Federation. IDF Diabetes Atlas, 10th Edition, 2021.
2. World Health Organization. Osteoarthritis Fact Sheet, 2022.
3. Market Research Future. Global Fixed Dose Combination Market, 2022.
4. IQVIA. Global Market Access Trends, 2022.
5. U.S. Food and Drug Administration. Consensi (sitagliptin and celecoxib) approval memo, 2017.

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This comprehensive overview aims to inform pharmaceutical stakeholders, investors, clinicians, and policy-makers regarding Consensi’s market dynamics and financial forecast.