amlodipine besylate Drug Patent Profile

When do Amlodipine Besylate patents expire, and what generic alternatives are available?

Amlodipine Besylate is a drug marketed by Synthon Pharms, Accord Hlthcare, Alkem, Amneal Pharms Ny, Aurobindo Pharma, Chartwell Rx, China Resources, Cipla, Corepharma, Epic Pharma Llc, Gedeon Richter Usa, Genpharm, Hikma, Hikma Pharms, Invagen Pharms, Lupin, Macleods Pharms Ltd, Mylan, Norvium Bioscience, Orbion Pharms, Oxford Pharms, Polygen Pharms, Puracap Pharm, Sciegen Pharms Inc, Sovereign Pharms, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Sunshine, Teva, Torrent Pharms, Unichem, Watson Labs, Wockhardt, Zydus Pharms Usa, Apotex, Dr Reddys, Zydus Pharms, Amneal, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Heritage, Lupin Pharms, Teva Pharms, Watson Labs Inc, Alembic, Hetero Labs, Novel Labs Inc, Teva Pharms Usa, Torrent, and Lupin Ltd. and is included in seventy NDAs.

The generic ingredient in AMLODIPINE BESYLATE is amlodipine besylate; hydrochlorothiazide; valsartan. There are fifty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.

Summary for amlodipine besylate

US Patents:	0
Applicants:	52
NDAs:	70
Finished Product Suppliers / Packagers:	39
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	58
Patent Applications:	5,135
Drug Prices:	Drug price information for amlodipine besylate
Drug Sales Revenues:	Drug sales revenues for amlodipine besylate
What excipients (inactive ingredients) are in amlodipine besylate?	amlodipine besylate excipients list
DailyMed Link:	amlodipine besylate at DailyMed

See drug prices for amlodipine besylate

See drug sales revenues for amlodipine besylate

Recent Clinical Trials for amlodipine besylate

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

Sponsor	Phase
Guangzhou Health Start Pharmaceutical Techology Co.,Ltd	Phase 1
Overseas Pharmaceuticals, Ltd.	Phase 1
American Society for Transplantation	Phase 4

See all amlodipine besylate clinical trials

Pharmacology for amlodipine besylate

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 besylate

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

US Patents and Regulatory Information for amlodipine besylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Puracap Pharm	AMLODIPINE BESYLATE	amlodipine besylate	TABLET;ORAL	078131-001	Sep 4, 2007		DISCN	No	No
Novel Labs Inc	AMLODIPINE BESYLATE AND VALSARTAN	amlodipine besylate; valsartan	TABLET;ORAL	202829-003	Mar 30, 2015	AB	RX	No	No
Teva	AMLODIPINE BESYLATE	amlodipine besylate	TABLET;ORAL	076846-003	Jun 28, 2007	AB	RX	No	No
Torrent	AMLODIPINE BESYLATE AND VALSARTAN	amlodipine besylate; valsartan	TABLET;ORAL	202377-003	Mar 30, 2015		DISCN	No	No
Hikma	AMLODIPINE BESYLATE	amlodipine besylate	TABLET;ORAL	077262-002	Jul 9, 2007		DISCN	No	No
Epic Pharma Llc	AMLODIPINE BESYLATE	amlodipine besylate	TABLET;ORAL	078552-002	Apr 8, 2009	AB	RX	No	No
Dr Reddys Labs Inc	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	077183-001	Apr 15, 2010	AB	RX	No	No

Expired US Patents for amlodipine besylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Synthon Pharms	AMLODIPINE BESYLATE	amlodipine besylate	TABLET, ORALLY DISINTEGRATING;ORAL	022026-001	Sep 27, 2007
Synthon Pharms	AMLODIPINE BESYLATE	amlodipine besylate	TABLET, ORALLY DISINTEGRATING;ORAL	022026-002	Sep 27, 2007
Synthon Pharms	AMLODIPINE BESYLATE	amlodipine besylate	TABLET, ORALLY DISINTEGRATING;ORAL	022026-003	Sep 27, 2007

International Patents for amlodipine besylate

See the table below for patents covering amlodipine besylate around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1448197
Norway	20042539
Argentina	037565	FORMAS DE SALES DE AMLODIPINA Y PROCEDIMIENTOS PARA PREPARARLAS.
World Intellectual Property Organization (WIPO)	03043635
Australia	2002343257

Supplementary Protection Certificates for amlodipine besylate

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
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	2007C/043	Belgium		PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
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
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
0443983	C300445	Netherlands		PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
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

Amlodipine besylate Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory of Amlodipine Besylate

Introduction to Amlodipine Besylate

Amlodipine besylate is a widely used antihypertensive medication, primarily prescribed for the treatment of hypertension and angina. Its efficacy in managing cardiovascular diseases has made it a cornerstone in the pharmaceutical industry.

Global Market Size and Growth

The global amlodipine besylate market has been experiencing steady growth, driven by several key factors. As of 2023, the market size was recorded at USD 1,867.0 million, with projections indicating it will reach USD 1,933.0 million in 2024 and USD 2,539.5 million by 2031, growing at a CAGR of 3.98% from 2024 to 2031[1].

Driving Factors for Market Growth

Rising Prevalence of Hypertension and Cardiovascular Diseases

The increasing prevalence of hypertension and cardiovascular diseases globally is a significant driver of the amlodipine besylate market. According to the WHO, approximately 1.28 million adults aged 30-79 in low and middle-income countries suffer from hypertension, with many remaining unaware of their condition[1].

Increasing Adoption of Combination Therapies

The market is also fueled by the increasing adoption of combination therapies that include amlodipine besylate. These combinations enhance patient compliance and accessibility, contributing to the sustained demand for this medication[1].

Advancements in Pharmaceutical Formulations

Advancements in pharmaceutical formulations, such as extended-release versions, are crucial in differentiating products and maintaining market competitiveness. These improved formulations help in better disease management and patient adherence[1].

Regulatory Approvals and Endorsements

Regulatory approvals and endorsements by health organizations play a vital role in ensuring amlodipine besylate remains a primary treatment for hypertension and angina. This validation helps in expanding the market and reinforcing the medication's importance in clinical practice[1].

Market Segmentation

By Form

The amlodipine besylate market is segmented into tablets, capsules, and liquid forms. The 5 mg tablets segment holds the largest market share due to its widespread use and efficacy in managing hypertension[3].

By Sales Channel

The market is segmented into hospital pharmacies, drug stores & pharmacies, online retails, and others. The online retail segment is expected to witness significant growth at a CAGR of 4.67% from 2024 to 2031, driven by the convenience and accessibility offered by e-commerce platforms[1].

Regional Analysis

North America

North America dominates the global amlodipine besylate market, with a market share of around 34.56% in 2023. This dominance is attributed 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 for rapid growth, registering a CAGR of 5.09% during 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[1].

Competitive Landscape

The amlodipine besylate market features 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].

Challenges and Opportunities

Fierce Competition from Generic Drugs

The market faces significant competition from generic drugs, leading to price erosion and reduced profit margins for manufacturers. To overcome this, pharmaceutical companies must focus on differentiating their products through improved formulations and combination therapies[1].

Increasing Demand and Supply Dynamics

The demand for amlodipine besylate is continuously growing, but it is often met with supply challenges. For instance, in March 2024, global prices surged due to peak demand and dwindling supplies, particularly post-Chinese New Year when manufacturing slows down in China[4].

Pharmacoeconomic Impact

A study on the pharmacoeconomic impact of amlodipine besylate in Italy highlighted its cost-effectiveness in treating coronary artery disease (CAD). The study showed that adding amlodipine besylate to standard care reduced major vascular events and revascularization procedures, resulting in significant savings in hospital expenditures[2].

Impact of Lifestyle Factors

The growth of the amlodipine besylate market is also influenced by lifestyle factors such as increased alcohol and tobacco consumption, which are well-established risk factors for hypertension. These factors contribute to the rising demand for effective antihypertensive medications like amlodipine besylate[3].

Digital Health Initiatives

The COVID-19 pandemic has accelerated the shift towards online purchasing of medications, including amlodipine besylate. Digital health initiatives and the growing comfort with online transactions among consumers are further contributing to the growth of the online retail segment[1].

Market Projections and Forecast

The global amlodipine besylate market is expected to continue its upward trajectory, driven by the increasing prevalence of cardiovascular diseases, advancements in pharmaceutical formulations, and the growing adoption of online retail channels. By 2032, the market is projected to reach USD 0.56 billion at a CAGR of 5.00% during the forecast period[3].

"Approximately 1.28 million adults aged 30-79 in low and middle-income countries are suffering from hypertension, whereas roughly 46% of the individuals suffering from the condition are unaware of their condition."[1]

Key Takeaways

• The global amlodipine besylate market is growing steadily, driven by the rising prevalence of hypertension and cardiovascular diseases.
• The market is segmented by form and sales channel, with online retail expected to see significant growth.
• North America and the Asia Pacific region are key markets, with the latter experiencing rapid growth.
• The competitive landscape is robust, with major pharmaceutical companies competing for market share.
• Lifestyle factors and digital health initiatives are influencing market dynamics.
• The market is projected to reach USD 2,539.5 million by 2031 and USD 0.56 billion by 2032.

FAQs

Q1: What is the current market size of the amlodipine besylate market?

The global amlodipine besylate market size was recorded at USD 1,867.0 million in 2023[1].

Q2: What are the primary drivers of the amlodipine besylate market growth?

The primary drivers include the rising prevalence of hypertension and cardiovascular diseases, increasing adoption of combination therapies, and advancements in pharmaceutical formulations[1].

Q3: Which region dominates the global amlodipine besylate market?

North America dominates the global amlodipine besylate market, with a market share of around 34.56% in 2023[1].

Q4: How is the online retail segment impacting the amlodipine besylate market?

The online retail segment is expected to witness significant growth at a CAGR of 4.67% from 2024 to 2031, driven by the convenience and accessibility offered by e-commerce platforms[1].

Q5: What are the challenges faced by the amlodipine besylate market?

The market faces significant competition from generic drugs, leading to price erosion and reduced profit margins for manufacturers. Supply challenges, such as those seen post-Chinese New Year, also impact the market[1][4].

Sources

1. Kings Research: Amlodipine Besylate Market Size & Share Forecast [2031]
2. PubMed: The pharmacoeconomic impact of amlodipine use on coronary artery disease
3. Market Research Future: Amlodipine Besylate Market Trends, Growth, Forecast 2032 | MRFR
4. ChemAnalyst: Global Amlodipine Besylate Prices Surge in March as Demand Peaks and Supplies Dwindle
5. UnivDatos: Amlodipine Besylate Market Current Analysis and Forecast (2023 – 2030)