AMLODIPINE BENZOATE - Generic Drug Details

What are the generic sources for amlodipine benzoate and what is the scope of patent protection?

Amlodipine benzoate is the generic ingredient in two branded drugs marketed by Amneal and Azurity, and is included in two NDAs. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amlodipine benzoate has eleven patent family members in six countries.

Two suppliers are listed for this compound.

Summary for AMLODIPINE BENZOATE

International Patents:	11
US Patents:	11
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	9
Patent Applications:	14
DailyMed Link:	AMLODIPINE BENZOATE at DailyMed

Pharmacology for AMLODIPINE BENZOATE

Drug Class	Calcium Channel Blocker Dihydropyridine Calcium Channel Blocker
Mechanism of Action	Calcium Channel Antagonists Cytochrome P450 3A Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for AMLODIPINE BENZOATE

C08CA	Dihydropyridine derivatives
C08C	SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VASCULAR EFFECTS
C08	CALCIUM CHANNEL BLOCKERS
C	Cardiovascular system

Paragraph IV (Patent) Challenges for AMLODIPINE BENZOATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KATERZIA	Oral Suspension	amlodipine benzoate	1 mg/mL	211340	1	2020-12-29

US Patents and Regulatory Information for AMLODIPINE BENZOATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	KATERZIA	amlodipine benzoate	SUSPENSION;ORAL	211340-001	Jul 8, 2019		RX	Yes	Yes	10,799,453		Y
Azurity	KATERZIA	amlodipine benzoate	SUSPENSION;ORAL	211340-001	Jul 8, 2019		RX	Yes	Yes	10,894,039
Azurity	KATERZIA	amlodipine benzoate	SUSPENSION;ORAL	211340-001	Jul 8, 2019		RX	Yes	Yes	11,918,685
Azurity	KATERZIA	amlodipine benzoate	SUSPENSION;ORAL	211340-001	Jul 8, 2019		RX	Yes	Yes	11,701,326		Y
Azurity	KATERZIA	amlodipine benzoate	SUSPENSION;ORAL	211340-001	Jul 8, 2019		RX	Yes	Yes	10,695,329		Y
Amneal	AMLODIPINE BENZOATE	amlodipine benzoate	SUSPENSION;ORAL	215035-001	Jun 13, 2023		DISCN	No	No
Azurity	KATERZIA	amlodipine benzoate	SUSPENSION;ORAL	211340-001	Jul 8, 2019		RX	Yes	Yes	11,364,230		Y

International Patents for AMLODIPINE BENZOATE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3773574	FORMULATIONS D'AMLODIPINE (AMLODIPINE FORMULATIONS)
Canada	3096101	FORMULATIONS D'AMLODIPINE (AMLODIPINE FORMULATIONS)
World Intellectual Property Organization (WIPO)	2019200143
Canada	3038989
China	112334134	氨氯地平制剂 (AMLODIPINE FORMULATIONS)
European Patent Office	3960158
World Intellectual Property Organization (WIPO)	2018067959

Supplementary Protection Certificates for AMLODIPINE BENZOATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
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
1507558	2012/018	Ireland		PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705
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	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

AMLODIPINE BENZOATE Market Analysis and Financial Projection Experimental

Amlodipine Besylate Market Dynamics and Financial Trajectory

Market Size and Growth Projections

The global Amlodipine Besylate market is poised for significant growth, driven by several key factors. As of 2023, the market size was estimated at USD 1,867.0 million and is projected to reach USD 2,539.5 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 3.98% from 2024 to 2031[1].

Drivers of Market Growth

Several factors are driving the growth of the Amlodipine Besylate market:

Rising Prevalence of Hypertension and Cardiovascular Diseases

Hypertension is increasingly common due to aging populations, sedentary lifestyles, and poor dietary habits. This condition is a major risk factor for cardiovascular diseases, which are among the leading causes of death globally. The World Health Organization (WHO) estimates that hypertension contributes to over 7.5 million deaths annually[5].

Increasing Adoption of Combination Therapies

The use of combination therapies, which often include Amlodipine Besylate, is on the rise. This trend is fueled by the need for more effective management of hypertension and cardiovascular diseases[1].

Advancements in Pharmaceutical Formulations

Advancements in pharmaceutical formulations have enhanced patient compliance and accessibility. New formulations and delivery methods are making Amlodipine Besylate more convenient and effective for patients[1].

Regulatory Approvals and Endorsements

Regulatory approvals and endorsements by health organizations further support the market growth. These endorsements ensure that Amlodipine Besylate remains a primary treatment for hypertension and angina management[1].

Competitive Landscape

The Amlodipine Besylate market is characterized by a robust competitive landscape with numerous global and regional pharmaceutical companies. Key players include Pfizer, Mylan, Reddy’s Laboratories, Apotex, Teva Pharmaceutical, Cipla, Hikma Pharmaceuticals, Strides Pharma, Upsher-Smith Laboratories, and InvaGen Pharmaceuticals[3].

Sales Channels and Distribution

The market is segmented based on sales channels, including hospital pharmacies, drug store & pharmacies, online retails, and others. The online retail segment is expected to witness significant growth at a CAGR of 4.67% during the forecast period, driven by the convenience and accessibility of e-commerce platforms for purchasing medications[1].

Regional Analysis

North America

North America holds a significant market share, with a valuation of USD 645.2 million in 2023. This dominance is due to the high prevalence of hypertension and cardiovascular diseases, advanced healthcare infrastructure, high healthcare spending, and widespread insurance coverage in the region[1].

Asia Pacific

The Asia Pacific region is poised to experience rapid growth, registering a CAGR of 5.09% over the forecast period. This growth is driven by increasing awareness regarding cardiovascular health and the rising prevalence of hypertension in the region. Government initiatives aimed at promoting preventive healthcare and early treatment are also boosting demand for antihypertensive drugs[1].

Europe

Europe is experiencing a high aging rate, leading to a higher occurrence of chronic illnesses like hypertension. The number of patients willing to take medicine to prevent or control disease increases with age, contributing to the overall demand for Amlodipine Besylate in the region[3].

Pharmacoeconomic Impact

The use of Amlodipine Besylate has significant pharmacoeconomic implications. Studies have shown that adding Amlodipine Besylate to standard care can reduce vascular events and the need for revascularization procedures, leading to savings in hospital expenditure. For instance, a study in Italy estimated that the total cost of adding Amlodipine Besylate to standard care amounted to 139,050 euros per 1000 patients treated for 36 months, which translates to a cost of 1780 euros per patient remaining free of any vascular event[2].

Clinical Benefits and Outcomes

Amlodipine Besylate has been shown to have favorable clinical outcomes in various studies. For example, the CAMELOT trial demonstrated that Amlodipine Besylate reduced the risk of hospitalizations for angina and revascularization procedures compared to the placebo group. The study showed a 31% risk reduction in composite cardiovascular endpoints, including hospitalization for angina and coronary revascularization[4].

Market Trends and Opportunities

Growing Awareness and Investments

Growing awareness programs regarding cardiovascular diseases and increasing investments in cardiovascular departments are driving the market growth. Companies are also investing in marketing strategies to differentiate their branded products from generic competitors[1].

Emerging Markets

Pharmaceutical companies can explore opportunities in emerging markets where hypertension rates are rising and healthcare access is improving. This presents a favorable investment climate, bolstered by ongoing research and development in the field[5].

Challenges and Considerations

Generic Competition

The ongoing patent expirations of major brands continue to foster the availability of cost-effective generics, intensifying competition and broadening patient access to this essential medication. Companies must navigate this competitive landscape by investing in R&D to develop novel formulations and strengthening collaborations with healthcare providers[1].

Regulatory Environment

The market is influenced by a strong regulatory framework, particularly in regions like North America. Companies must comply with these regulations to maintain their market presence and ensure the continued use of Amlodipine Besylate as a primary treatment for hypertension and angina[1].

Key Takeaways

• The global Amlodipine Besylate market is projected to grow significantly, driven by the rising prevalence of hypertension and cardiovascular diseases.
• The market is characterized by a robust competitive landscape with key players investing in R&D and marketing strategies.
• Online retail is a growing sales channel, driven by the convenience and accessibility of e-commerce platforms.
• Regional growth is strong in North America, Asia Pacific, and Europe, fueled by different demographic and healthcare factors.
• Amlodipine Besylate has demonstrated favorable clinical outcomes and pharmacoeconomic benefits.

Frequently Asked Questions (FAQs)

Q: What is the current market size of the Amlodipine Besylate market? A: As of 2023, the global Amlodipine Besylate market size was estimated at USD 1,867.0 million[1].

Q: What is the projected growth rate of the Amlodipine Besylate market? A: The market is projected to grow at a CAGR of 3.98% from 2024 to 2031[1].

Q: Which region holds the largest market share for Amlodipine Besylate? A: North America holds the largest market share, with a valuation of USD 645.2 million in 2023[1].

Q: What are the key drivers of the Amlodipine Besylate market growth? A: The key drivers include the rising prevalence of hypertension and cardiovascular diseases, increasing adoption of combination therapies, advancements in pharmaceutical formulations, and regulatory approvals[1].

Q: How does Amlodipine Besylate impact healthcare costs? A: Amlodipine Besylate can reduce healthcare costs by reducing vascular events and the need for revascularization procedures, leading to savings in hospital expenditure[2].

Cited Sources:

1. Kings Research: Amlodipine Besylate Market Size & Share Forecast [2031][1]
2. PubMed: The pharmacoeconomic impact of amlodipine use on coronary artery disease[2]
3. Market Research Future: Amlodipine Besylate Market Trends, Growth, Forecast 2032[3]
4. FDA: Amlodipine Besylate Tablets[4]
5. Market Research Intellect: Amlodipine Besylate Market Size And Projection[5]