Amlodipine besylate - Generic Drug Details

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

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 5MG BASE	TABLET;ORAL
		EQ 2.5MG BASE	TABLET;ORAL
		EQ 10MG 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
Mylan	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	200465-003	Nov 29, 2013		DISCN	No	No
Hetero Labs Ltd V	AMLODIPINE AND OLMESARTAN MEDOXOMIL	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	209591-002	Feb 14, 2025	AB	RX	No	No
Purple Biotech	CONSENSI	amlodipine besylate; celecoxib	TABLET;ORAL	210045-002	May 31, 2018		DISCN	Yes	No	10,350,171		Y

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	022026-003	Sep 27, 2007	6,828,339
Synthon Pharms	AMLODIPINE BESYLATE	amlodipine besylate	TABLET, ORALLY DISINTEGRATING;ORAL	022026-001	Sep 27, 2007	6,828,339
Synthon Pharms	AMLODIPINE BESYLATE	amlodipine besylate	TABLET, ORALLY DISINTEGRATING;ORAL	022026-002	Sep 27, 2007	6,828,339

Market Dynamics and Financial Trajectory for Amlodipine Besylate

Last updated: April 19, 2026

What Is the Current Market for Amlodipine Besylate?

Amlodipine besylate is a calcium channel blocker used primarily for hypertension and angina. It has widespread global approval, with a robust prescription volume driven by the high prevalence of cardiovascular diseases. The drug's patent expiration in various regions has increased generic competition, exerting downward pressure on prices but expanding access.

In 2022, the global antihypertensive market is valued at approximately $32 billion. Amlodipine accounts for nearly 20% of this segment, translating to annual sales of roughly $6.4 billion. The drug is marketed under multiple brand names including Norvasc (Pfizer), Amvasc (Abbott), and generics.

Prescriptions for amlodipine are growing at an annual rate near 4%, driven by aging populations and increased awareness of cardiovascular health. North America contributes approximately 55% of sales, Europe accounts for 25%, and the rest of the world makes up 20%.

How Do Patent Expiration and Generics Affect Commercial Performance?

Patent expiration occurs at different times across jurisdictions:

Region	Patent Expiry	Impact
U.S.	2017-2023	Surge in generic availability
EU	2018-2024	Increased price competition
Emerging markets	Varies, 2020s	Rapid generic uptake

The post-patent period has seen a decline in branded sales by approximately 20% globally since 2017, offset by volume growth from generics. Price erosion in mature markets averages 10-15% annually for generics.

What Are the Key Factors Driving Market Growth?

• Growing Cardiovascular Disease (CVD) Burden: Globally, CVD remains the leading cause of death, with an estimated 17.9 million deaths in 2019 (WHO). Aging populations and sedentary lifestyles contribute to increased antihypertensive drug demand.
• Increasing Access in Developing Countries: As healthcare infrastructure improves, prescriptions grow at a compound annual growth rate (CAGR) of 7% in emerging markets, representing a key area of expansion.
• Monotherapy and Fixed-Dose Combinations: The shift toward combination therapies enhances adherence but can disrupt individual drug sales. Amlodipine is frequently combined with other antihypertensives, influencing market size.

How Will Financial Trajectories Evolve?

Projected sales trajectories are influenced by patent landscape, pricing strategies, and competitive entries:

Year	Estimated Global Sales	Factors
2022	$6.4 billion	Current market, generic competition
2025	$4.8 billion	Patent expiries, price erosion
2030	$3.5 billion	Market saturation, new therapies

The decline from peak brand sales is expected to stabilize around $3–4 billion by 2030, with potential for growth in emerging markets reaching $1 billion annually.

What Regulatory and Policy Changes Impact its Future?

• Pricing Regulations: Countries like the U.K. and Canada impose strict price controls on generics, restricting revenue growth.
• Approval of Biosimilars and Competitive Alternatives: Emerging drugs targeting hypertension could divert market share, affecting long-term sales.
• Patent Strategies: Companies securing secondary patents or formulations can prolong market exclusivity until at least 2030.

What Are the Potential Risks and Opportunities?

Risks

• Accelerated generic penetration reducing margins.
• Competitive developments from alternative therapies like dual-action agents.
• Regulatory pressures decreasing drug prices.

Opportunities

• Expansion into new indications such as hypertensive emergencies.
• Focus on formulation innovations like extended-release versions.
• Penetration into underserved markets with limited antihypertensive options.

Summary of Key Data Points

Aspect	Data/Insight
Global antihypertensive market	$32 billion (2022)
Amlodipine share	20% of antihypertensive market ($6.4 billion)
Generic sales decline post-2017	20% reduction in branded sales
Emerging market growth	7% CAGR
Projected sales (2030)	$3.5 billion globally, $1 billion in emerging markets

Key Takeaways

• Amlodipine besylate commands a significant share of the antihypertensive market.
• Patent expiries have led to increasing generic competition, reducing margins.
• Growth in emerging markets offsets decline in developed markets.
• Regulatory policies influence pricing and access.
• Future revenue depends on market penetration, therapeutic innovation, and competition management.

FAQs

1. How does patent expiry impact a drug's market?
Patent expiry allows generic manufacturers to produce lower-cost copies, increasing competition and lowering prices, thereby reducing profit margins for branded versions.

2. What therapeutic developments could challenge amlodipine?
New antihypertensive agents and combination therapies with better efficacy or fewer side effects may capture market share from traditional calcium channel blockers.

3. Will emerging markets sustain growth?
Yes. Continued healthcare infrastructure development and rising hypertension prevalence drive demand, making emerging markets a critical growth area.

4. How can pharma companies extend amlodipine's market longevity?
Formulation innovations, including extended-release versions, new dosing regimens, and novel indications, can prolong exclusivity and sales.

5. What role does pricing regulation play in future sales?
Stringent pricing controls in certain regions may limit revenue growth, especially for generics, influencing strategic decisions around marketing and R&D.

---

References

[1] World Health Organization. (2019). Cardiovascular diseases (CVDs).
[2] MarketsandMarkets. (2022). Antihypertensive Drugs Market.
[3] IQVIA. (2022). Global Prescription Trends.
[4] European Medicines Agency. (2021). Patent expiries and market impacts.
[5] U.S. Food and Drug Administration. (2022). Market exclusivity and patent data.