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 are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amlodipine besylate; celecoxib has nine patent family members in seven countries.

Summary for amlodipine besylate; celecoxib

International Patents:	9
US Patents:	5
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

Constraining patent/regulatory exclusivity:

9,662,315

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	210045-003	May 31, 2018		DISCN	Yes	No	9,408,837
Purple Biotech	CONSENSI	amlodipine besylate; celecoxib	TABLET;ORAL	210045-002	May 31, 2018		DISCN	Yes	No	9,408,837
Purple Biotech	CONSENSI	amlodipine besylate; celecoxib	TABLET;ORAL	210045-001	May 31, 2018		DISCN	Yes	No	9,662,315		Y

International Patents for amlodipine besylate; celecoxib

Country	Patent Number	Title	Estimated Expiration
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.)
Australia	2009260632	Pharmaceutical formulations and methods of use which combine non-steroidal anti-inflammatory compounds with anti-hypertensive compounds
World Intellectual Property Organization (WIPO)	2019008583

Supplementary Protection Certificates for amlodipine besylate; celecoxib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
0443983	C00443983/03	Switzerland		PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009

Amlodipine besylate; celecoxib Market Analysis and Financial Projection Experimental

Amlodipine Besylate and Celecoxib: Market Dynamics and Financial Trajectory

Introduction

Amlodipine besylate, a calcium channel blocker, and celecoxib, a nonsteroidal anti-inflammatory drug (NSAID), are widely used medications, often combined in the fixed-dose formulation known as Consensi. This article delves into the market dynamics and financial trajectory of these drugs, particularly focusing on their combined formulation.

Market Size and Growth

The global market for amlodipine besylate is substantial and growing. As of 2023, the market size was valued at approximately USD 1,867 million, with projections to reach USD 2,539.5 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 3.98% from 2024 to 2031[3].

Regional Analysis

The market is geographically diverse, with North America holding a significant share. In 2023, North America accounted for around 34.56% of the global market, valued at USD 645.2 million. This dominance is attributed to the high prevalence of hypertension and cardiovascular diseases, advanced healthcare infrastructure, and robust research and development activities in the region[3].

Asia Pacific Growth

The Asia Pacific region is expected to experience rapid growth, with a CAGR of 5.09% over the forecast period. This growth is driven by increasing awareness about cardiovascular health, rising prevalence of hypertension, and government initiatives promoting preventive healthcare and early treatment[3].

Applications and Uses

Hypertension and Cardiovascular Diseases

Amlodipine besylate is primarily used to manage hypertension and angina. It works by inhibiting the contraction of smooth and cardiac muscles through the blockade of calcium ions, leading to peripheral vasodilation and reduced blood pressure[2].

Osteoarthritis

Celecoxib, when combined with amlodipine besylate in Consensi, is used to treat osteoarthritis. This combination allows for the simultaneous management of hypertension and osteoarthritis in adults, enhancing patient compliance and reducing the need for multiple medications[5].

Combination Therapy: Consensi

Approval and Medical Use

Consensi, the fixed-dose combination of amlodipine besylate and celecoxib, was approved by the FDA in May 2018. It is indicated for adults for whom treatment with both amlodipine for hypertension and celecoxib for osteoarthritis is appropriate[5].

Side Effects and Safety

Common side effects of Consensi include edema, abdominal pain, diarrhea, dyspepsia, and peripheral edema, among others. Despite these side effects, the combination therapy offers a convenient and effective treatment option for patients managing both conditions[5].

Market Drivers

Increasing Prevalence of Hypertension and Cardiovascular Diseases

The rising prevalence of hypertension and cardiovascular diseases globally is a significant driver for the amlodipine besylate market. According to the WHO, approximately 1.28 million adults in low and middle-income countries suffer from hypertension, with many remaining unaware of their condition[3].

Advancements in Pharmaceutical Formulations

Advancements in pharmaceutical formulations, such as extended-release versions and combination therapies, enhance patient compliance and accessibility. These innovations help differentiate products in a competitive market and drive growth[3].

Regulatory Approvals and Endorsements

Regulatory approvals and endorsements by health organizations play a crucial role in market expansion. The approval of new formulations and the endorsement by health organizations ensure that amlodipine besylate remains a primary treatment for hypertension and angina management[3].

Market Challenges

Generic Competition

The amlodipine besylate market faces significant competition from generic drugs, leading to price erosion and reduced profit margins for manufacturers. Overcoming this challenge requires pharmaceutical companies to focus on differentiating their products through improved formulations and combination therapies[3].

Online Retail Growth

The online retail segment is set to witness significant growth, driven by the increasing adoption of e-commerce platforms for purchasing medications. This shift, accelerated by the COVID-19 pandemic, highlights the importance of online retail in ensuring continuous access to essential medications like amlodipine besylate[3].

Financial Trajectory

Revenue Projections

The global amlodipine besylate market is projected to grow from USD 1,933 million in 2024 to USD 2,539.5 million by 2031. This growth is driven by the increasing demand for effective antihypertensive medications and the expanding use of combination therapies[3].

Sales Channels

The market is segmented by sales channels into hospital pharmacies, drug store & pharmacies, online retails, and others. The online retail segment is expected to grow at a CAGR of 4.67% during the forecast period, driven by the convenience and accessibility offered by e-commerce platforms[3].

Competitive Landscape

The amlodipine besylate market is characterized by a robust competitive landscape with numerous global and regional pharmaceutical companies. The expansion of the market is fueled by growing awareness programs regarding cardiovascular diseases and increasing investments in cardiovascular departments[3].

Key Takeaways

• The global amlodipine besylate market is valued at USD 1,867 million in 2023 and is projected to reach USD 2,539.5 million by 2031.
• North America holds a significant market share due to high prevalence of hypertension and advanced healthcare infrastructure.
• The Asia Pacific region is expected to experience rapid growth driven by increasing awareness and government initiatives.
• Combination therapies like Consensi enhance patient compliance and reduce the need for multiple medications.
• Generic competition and online retail growth are key factors influencing market dynamics.

FAQs

What is the current market size of the amlodipine besylate market?

The global market size of amlodipine besylate was estimated at USD 1,867 million in 2023[3].

Which region is the largest consumer of amlodipine besylate?

North America is the largest consumer of amlodipine besylate, accounting for around 34.56% of the global market in 2023[3].

What is the projected growth rate of the amlodipine besylate market from 2024 to 2031?

The market is projected to grow at a CAGR of 3.98% from 2024 to 2031[3].

What are the common side effects of the combination therapy Consensi?

Common side effects include edema, abdominal pain, diarrhea, dyspepsia, and peripheral edema, among others[5].

How has the COVID-19 pandemic impacted the amlodipine besylate market?

The pandemic has accelerated the shift toward online purchasing, highlighting the importance of online retail in ensuring continuous access to essential medications like amlodipine besylate[3].

Sources

1. Market Research Future - Amlodipine Besylate Market Size, Share & Forecast Report 2032
2. PLOS ONE - Development of UV spectrophotometry methods for concurrent quantification of amlodipine besylate and celecoxib
3. Kings Research - Amlodipine Besylate Market Size & Share Forecast [2031]
4. ChemAnalyst - Amlodipine Besylate Market Size, Share, Growth & Forecast
5. Wikipedia - Amlodipine/celecoxib