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 twenty-one branded drugs marketed by Brillian Pharma, 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, Graviti Pharms, Hikma, Hikma Pharms, Invagen Pharms, Lupin, Mylan, Orbion Pharms, Oxford Pharms, Pharmobedient, Puracap Labs Blu, Puracap Pharm, Sciegen Pharms, Sovereign Pharms, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Sunshine, Teva, Teva Pharms Inc, Torrent Pharms, Unichem, Watson Labs, Wockhardt, Zydus Pharms Usa, Viatris, Alembic, Apotex, Dr Reddys, Neocubes Pharma, Pharmacia, Amneal, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Heritage, Lupin Pharms, Rising, Teva Pharms, Watson Labs Inc, Sandoz, Purple Biotech, Hetero Labs Ltd V, Macleods Pharms Ltd, Micro Labs, Ph Health, Piramal, Teva Pharms Usa, Torrent, Cosette, Lupin Ltd, Strides Pharma Intl, Novartis, Azurity, Accord Hlthcare Inc, Ajanta Pharma Ltd, Alkem Labs Ltd, Glenmark Pharms Ltd, Jubilant Generics, Zydus Pharms, Adhera, Boehringer Ingelheim, Hetero Labs, and Novel Labs Inc, and is included in one hundred and eleven NDAs. There are eleven 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-three suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for AMLODIPINE BESYLATE

US Patents:	11
Tradenames:	21
Applicants:	77
NDAs:	111
Drug Master File Entries:	27
Finished Product Suppliers / Packagers:	43
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	60
Patent Applications:	7,223
Drug Prices:	Drug price trends for AMLODIPINE BESYLATE
Drug Sales Revenues:	Drug sales revenues for AMLODIPINE BESYLATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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
Third Military Medical University	PHASE4
Overseas Pharmaceuticals, Ltd.	Phase 1
Guangzhou Health Start Pharmaceutical Techology Co.,Ltd	Phase 1

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	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
Azurity	WIDAPLIK	amlodipine besylate; indapamide; telmisartan	TABLET;ORAL	219423-001	Jun 5, 2025		DISCN	Yes	No	12,465,599		Y
Alembic	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	217279-006	May 22, 2025	AB	RX	No	No
Puracap Pharm	AMLODIPINE BESYLATE	amlodipine besylate	TABLET;ORAL	078131-003	Sep 4, 2007		DISCN	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	6,828,339
Viatris	NORVASC	amlodipine besylate	TABLET;ORAL	019787-002	Jul 31, 1992	4,572,909*PED
Viatris	NORVASC	amlodipine besylate	TABLET;ORAL	019787-003	Jul 31, 1992	4,879,303*PED

Market Dynamics and Financial Trajectory for Amlodipine Besylate

Last updated: March 11, 2026

Amlodipine besylate is a widely prescribed calcium channel blocker used primarily for hypertension and coronary artery disease. The drug’s market growth is driven by factors like increasing global hypertension prevalence, aging populations, and expanding cardiovascular disease treatment. The compound's patent status, generic entry, and regulatory environment significantly influence revenue streams.

Key Market Drivers

Rising Hypertension Incidence

An estimated 1.39 billion adults globally have hypertension (WHO, 2021). This constant increase fuels demand for antihypertensive therapies, with amlodipine besylate accounting for a significant fraction of prescriptions.

Aging Population

Older demographics more frequently develop cardiovascular conditions, prompting sustained demand. The World Population Ageing report projects adults over 60 will comprise 16% of the global population by 2030.

Expanding Cardiovascular Treatment

Innovations in combination therapies and increased awareness about cardiovascular health expand market opportunities. Amlodipine’s higher efficacy, reduced side effects, and low cost maintain its market position.

Patent Status and Generic Competition

Patent Expiry

Pfizer’s patent on Norvasc (amlodipine besylate) expired in 2014 in the U.S., allowing generic manufacturers to produce lower-cost versions.

Generic Market Entry

Post-2014, generic variants flooded markets, causing prices for amlodipine to decline significantly. This has increased affordability and access, boosting volume sales, but compressed profit margins for branded products.

Impact on revenue:

Year	Branded Sales	Generic Sales	Total Market Size
2010	$2.2 billion	N/A	$2.2 billion
2015	$1.2 billion	$2.8 billion	$4 billion
2020	$500 million	$3.5 billion	$4 billion

Source: IMS Health Data (2015-2020)

Market Share Distribution

Generics hold approximately 85–90% of worldwide amlodipine sales, with branded products primarily in emerging markets or controlled prescription segments.

Regulatory Environment and Pricing Policies

Regulatory Approvals

Amlodipine is approved by major agencies including the FDA, EMA, and Japan’s PMDA. Automating regulatory pathways, such as expedited reviews for biosimilars or formulations, influences market expansion.

Pricing and Reimbursement

Price reductions due to policy changes and reimbursement restrictions in countries like the U.S. (via CMS) have narrowed profit margins. Countries like India and China witness price controls that limit revenue.

Financial Trajectory

Revenue Trends

The global amlodipine market is projected to grow at a compound annual growth rate (CAGR) of 3–4% from 2021 through 2028, reaching approximately USD 7 billion.

Market Segmentation

Segment	Share (2022)	CAGR (2022–2028)
Brand-name	10%	1%
Generics	90%	4%

Key Players

• Pfizer (brand: Norvasc)
• Teva Pharmaceuticals
• Mylan (now part of Viatris)
• Sun Pharma
• Dr. Reddy’s Laboratories

These companies' strategies include expanding to emerging markets, developing fixed-dose combinations, and exploring biosimilars.

Challenges and Opportunities

Challenges

• Price competition with generics diminishes top-line growth.
• Regulatory constraints threaten market expansion.
• Increasing awareness invites stricter pricing policies.

Opportunities

• Developing new formulations, such as extended-release variants.
• Expanding into underserved markets.
• Combining amlodipine with other antihypertensives for improved efficacy.

Key Takeaways

• The global amlodipine besylate market sees steady growth driven by hypertension prevalence and aging demographics.
• Patent expiration in 2014 led to robust generic competition, reducing profitability for brand firms.
• Market share favors generics, which comprise the majority of sales; branded segment remains modest.
• Regulatory and pricing policies differ globally, impacting revenue streams.
• Growth prospects include formulation innovation and expansion into emerging markets.

FAQs

1. How does patent expiration affect amlodipine sales?
Patent expiry enables generic manufacturers to produce lower-cost versions, increasing competition, reducing prices, and shifting market share from branded products to generics.

2. What is the projected global market size for amlodipine in 2028?
Approximately USD 7 billion, with a CAGR of 3–4% from 2021 onward.

3. Which regions offer the highest growth potential?
Emerging markets such as India, China, and Latin America exhibit rapid growth due to large hypertensive populations and expanding healthcare infrastructure.

4. How are regulatory policies impacting the amlodipine market?
Streamlined approval processes support market entry, while price controls and reimbursement policies restrict revenue growth in certain countries.

5. What are the strategic opportunities for pharmaceutical companies?
Developing novel formulations, expanding into underserved regions, and creating fixed-dose combination therapies provide avenues for growth.

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References

1. World Health Organization (2021). Hypertension. Retrieved from https://www.who.int/news-room/fact-sheets/detail/hypertension
2. IMS Health (2015–2020). Global Pharmaceutical Sales Data.
3. U.S. Food and Drug Administration (2022). Approved Drug Products.
4. European Medicines Agency (2022). Marketing Authorization Approvals.
5. World Population Ageing (2019). United Nations.