Amlodipine besylate; celecoxib - Generic Drug Details

What are the generic drug sources for amlodipine besylate; celecoxib and what is the scope of freedom to operate?

Amlodipine besylate; celecoxib is the generic ingredient in one branded drug marketed by Purple Biotech and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Amlodipine besylate; celecoxib has two patent family members in two countries.

Summary for amlodipine besylate; celecoxib

International Patents:	2
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Clinical Trials:	3
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for amlodipine besylate; celecoxib
DailyMed Link:	amlodipine besylate; celecoxib at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for amlodipine besylate; celecoxib

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 amlodipine besylate; celecoxib

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Haining Health-Coming Biotech Co., Ltd.	Phase 2
Alphacait, LLC	Phase 2
Kitov Pharma Ltd	Phase 3

See all amlodipine besylate; celecoxib clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for amlodipine besylate; celecoxib

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 AMLODIPINE BESYLATE; CELECOXIB

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 amlodipine besylate; celecoxib

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

International Patents for amlodipine besylate; celecoxib

Country	Patent Number	Title	Estimated Expiration
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)
World Intellectual Property Organization (WIPO)	2019008583

Supplementary Protection Certificates for amlodipine besylate; celecoxib

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
1915993	300625	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

Market Dynamics and Financial Trajectory for Amlodipine Besylate and Celecoxib

Last updated: July 29, 2025

Introduction

The pharmaceutical landscape for antihypertensive and analgesic drugs is driven by evolving healthcare needs, regulatory shifts, patient demographics, and technological advances. Among these categories, amlodipine besylate—a calcium channel blocker—and celecoxib—a selective COX-2 inhibitor—stand out due to their widespread clinical use, patent status, and market growth potential. This analysis explores the current market dynamics and financial trajectories shaping their future landscape.

Market Overview

Amlodipine besylate is among the most prescribed antihypertensives globally, owing to its proven efficacy, safety profile, and affordability. Its broad application in managing hypertension and angina pectoris positions it as a cornerstone therapy, particularly in aging populations. Conversely, celecoxib occupies a significant niche in the NSAID segment, mainly for osteoarthritis, rheumatoid arthritis, and acute pain management, especially for patients with contraindications to traditional NSAIDs.

Market Drivers

Growing Prevalence of Cardiovascular and Musculoskeletal Disorders

The rise in hypertension, driven by lifestyle factors, obesity, and aging demographics, sustains high demand for amlodipine. According to the World Health Organization (WHO), cardiovascular diseases remain the leading cause of death globally, reinforcing the demand for antihypertensive agents [1].

Similarly, increasing prevalence of osteoarthritis and rheumatoid arthritis fuels celecoxib’s market. The CDC reports a steady rise in osteoarthritis cases among aging populations, with NSAIDs representing first-line symptomatic treatments [2].

Patent Expiry and Generic Competition

The expiration of patents for amlodipine in various jurisdictions has catalyzed a surge in generic formulations, leading to price reductions and expanded access. For celecoxib, patent expiries in key markets, including the U.S., have resulted in a proliferation of generics, intensifying market competition.

Regulatory and Safety Considerations

Amlodipine's well-established safety profile supports its sustained use. In contrast, celecoxib's market has been influenced by safety concerns—particularly cardiovascular risks identified in post-marketing surveillance—prompting regulatory scrutiny [3]. Such safety profiles influence formulary decisions, prescribing patterns, and market growth.

Technological Innovations and Formulation Advances

Extended-release formulations, combination therapies, and biosimilar development impact both drugs' market penetration. For instance, fixed-dose combinations of amlodipine with other antihypertensives enhance adherence and therapeutic efficacy, expanding market opportunities.

Market Challenges

Regulatory Environment and Safety Alerts

The safety profile of celecoxib led to FDA warnings and class-effect restrictions, impacting sales. Similarly, differing regulatory stances across markets affect patent expiration timelines and generic entry.

Pricing Pressures and Reimbursement Policies

Healthcare systems worldwide are under cost-containment pressures, favoring generic and biosimilar products. The resultant price erosion affects revenue streams for originators and impacts profitability projections.

Competitive Landscape

The proliferation of alternative antihypertensives—such as ACE inhibitors and diuretics—and NSAIDs create competitive pressures, especially from low-cost generics.

Financial Trajectories

Amlodipine Besylate

Market Valuation and Growth Outlook

Pre-pandemic, the global antihypertensive drugs market was valued at approximately USD 25 billion, with amlodipine constituting a significant share. Post-2020, growth is expected to accelerate at a CAGR of 3-5%, driven by aging populations and improved access in emerging markets [4].

Revenue Streams and Patent Impact

Since patent expiries in major markets, generics account for the majority of sales, reducing revenue for originators. However, branded formulations featuring unique formulations or combination therapies retain premium pricing.

Emerging Markets and Access

Emerging economies present substantial growth potential, driven by expanding healthcare infrastructure and rising hypertension prevalence. Companies investing in local manufacturing and supply chain optimization can capitalize on this growth.

Celecoxib

Market Size and Growth Potential

The global NSAID market was valued at USD 13.2 billion in 2021, with celecoxib capturing a significant segment, particularly in chronic pain management. Growth projections suggest a CAGR of 2-4%, slowing due to safety concerns and generic competition.

Patent Lifecycles and Generics

Following patent expiries, generic celecoxib sales surged, sharply reducing revenue for originator brands. However, niche markets, such as formulations with enhanced safety profiles or combination drugs, offer incremental revenue.

Regulatory Trends and Safety Profiles

Ongoing safety evaluations influence sales trajectories. Stricter labeling and risk management programs may limit market expansion but could also create opportunities for safer NSAID alternatives.

Market Trends and Future Outlook

Shift Toward Personalized Medicine

Biomarker-driven therapies and targeted treatments threaten to marginalize traditional drugs like amlodipine and celecoxib unless they adapt with combination strategies or future formulations.

Digital and Pharmacovigilance Technologies

Enhanced post-market surveillance and real-world data analytics enable better safety profiling—particularly relevant for celecoxib, where safety concerns impact market share.

Pricing and Reimbursement Strategies

Cost pressures will continue to favor generics and biosimilars, resulting in constrained revenue growth for brand-name drugs but expanding access.

Pipeline and Innovation

Proprietary formulations, such as fixed-dose combinations (e.g., amlodipine with atorvastatin) and innovative delivery systems, promise to sustain or even enhance market share despite generic competition.

Conclusion

Amlodipine besylate and celecoxib exemplify distinct yet interconnected market dynamics within their respective therapeutic niches. Amlodipine's broad application and favorable safety profile underpin a resilient and growing market, particularly accelerated by demographic shifts and emerging market expansion. Celecoxib’s trajectory is more nuanced, shaped by safety concerns, patent expiries, and competition from safer or more effective alternatives. Strategic focus on innovation, safety, and market access will be essential for sustained financial success.

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Key Takeaways

• Amlodipine besylate’s market remains robust, driven by hypertension prevalence, generic penetration, and combination therapies, with growth projected at 3-5% CAGR globally.
• Celecoxib’s market faces stagnation due to safety concerns, patent loss, and intense generic competition, with growth slowing to 2-4% CAGR; niche markets and formulations offer new revenue avenues.
• Emerging markets represent significant growth opportunities for both drugs, benefiting from expanding healthcare infrastructure and increasing disease burden.
• Regulatory scrutiny and safety profiles are critical determinants of market trajectory, prompting companies to innovate with formulations and safety-enhanced products.
• Competitive pressures will persist; investment in technology, pharmacovigilance, and personalized medicine approaches will be pivotal to maintaining market relevance.

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FAQs

1. How will patent expiries impact the revenues of amlodipine besylate and celecoxib?
Patent expiries for both drugs lead to a surge in generic competition, significantly reducing original-brand revenues. Companies often counter this with new formulations, combination drugs, or differentiated safety profiles to sustain profitability.

2. What safety concerns influence the market trajectory of celecoxib?
Post-marketing data linked celecoxib to increased cardiovascular risk, prompting regulatory warnings and limited formulary inclusion. Such concerns affect prescribing behavior and market share, especially when competing with safer alternatives.

3. Which regions offer the most growth potential for amlodipine and celecoxib?
Emerging markets, including Asia-Pacific and Latin America, present substantial growth opportunities due to increasing hypertension and chronic pain prevalence, coupled with improving healthcare infrastructure.

4. How are pharmaceutical companies innovating to sustain market share?
Investments in fixed-dose combination therapies, novel formulations with enhanced safety or convenience, and digital pharmacovigilance tools are strategies to differentiate and improve patient adherence.

5. Will biosimilars play a role in the future of these drugs?
While biosimilars are more relevant for biologic therapies, the development of complex generics and advanced formulations will continue to influence the competitiveness and financial trajectory of small-molecule drugs like amlodipine and celecoxib.

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Sources

1. World Health Organization. Cardio metabolic risk factors, 2022.
2. Centers for Disease Control and Prevention. Osteoarthritis surveillance, 2021.
3. U.S. Food & Drug Administration. Celecoxib safety alert, 2016.
4. Market Research Future. Antihypertensive Drugs Market Forecast, 2022.