AMLODIPINE BESYLATE - Generic Drug Details

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

Amlodipine besylate is the generic ingredient in nineteen branded drugs marketed by Cmp Dev Llc, 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, Viatris, Apotex, Dr Reddys, Zydus Pharms, Pharmacia, Amneal, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Heritage, Lupin Pharms, Teva Pharms, Watson Labs Inc, Sandoz, Purple Biotech, Endo Operations, Teva Pharms Usa, Torrent, Cosette, Lupin Ltd, Novartis, Accord Hlthcare Inc, Ajanta Pharma Ltd, Alembic, Alkem Labs Ltd, Glenmark Pharms Ltd, Jubilant Generics, Micro Labs, Adhera, Boehringer Ingelheim, Hetero Labs, and Novel Labs Inc, and is included in one hundred and one NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are twenty-seven drug master file entries for amlodipine besylate. Forty-seven suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for AMLODIPINE BESYLATE

US Patents:	10
Tradenames:	19
Applicants:	68
NDAs:	101
Drug Master File Entries:	27
Finished Product Suppliers / Packagers:	47
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	58
Patent Applications:	7,057
Drug Prices:	Drug price trends 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

Generic filers with tentative approvals for AMLODIPINE BESYLATE

Applicant	Application No.	Strength	Dosage Form
		EQ 10MG BASE	TABLET;ORAL
		EQ 5MG BASE	TABLET;ORAL
		EQ 2.5MG BASE	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for AMLODIPINE BESYLATE

Drug Class	Dihydropyridine Calcium Channel Blocker 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
Macleods Pharms Ltd	AMLODIPINE BESYLATE AND VALSARTAN	amlodipine besylate; valsartan	TABLET;ORAL	207292-002	Oct 11, 2024	AB	RX	No	No
Glenmark Pharms Ltd	AMLODIPINE AND OLMESARTAN MEDOXOMIL	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	207807-004	Jul 5, 2017		DISCN	No	No
Norvium Bioscience	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	077375-002	May 21, 2010		DISCN	No	No
Zydus Pharms Usa	AMLODIPINE BESYLATE	amlodipine besylate	TABLET;ORAL	078226-001	Jul 9, 2007	AB	RX	No	No
Aurobindo Pharma	AMLODIPINE BESYLATE AND VALSARTAN	amlodipine besylate; valsartan	TABLET;ORAL	206512-003	Apr 22, 2016	AB	RX	No	No
Torrent	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	201593-001	Jun 3, 2015		DISCN	No	No
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-009	Jul 29, 2004	AB	RX	Yes	No

Expired US Patents for AMLODIPINE BESYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	NORVASC	amlodipine besylate	TABLET;ORAL	019787-001	Jul 31, 1992
Viatris	NORVASC	amlodipine besylate	TABLET;ORAL	019787-003	Jul 31, 1992
Synthon Pharms	AMLODIPINE BESYLATE	amlodipine besylate	TABLET, ORALLY DISINTEGRATING;ORAL	022026-001	Sep 27, 2007
Viatris	NORVASC	amlodipine besylate	TABLET;ORAL	019787-002	Jul 31, 1992
Viatris	NORVASC	amlodipine besylate	TABLET;ORAL	019787-002	Jul 31, 1992
Viatris	NORVASC	amlodipine besylate	TABLET;ORAL	019787-001	Jul 31, 1992
Synthon Pharms	AMLODIPINE BESYLATE	amlodipine besylate	TABLET, ORALLY DISINTEGRATING;ORAL	022026-003	Sep 27, 2007

AMLODIPINE BESYLATE Market Analysis and Financial Projection Experimental

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)