AMLODIPINE BESYLATE Drug Patent Profile

Which patents cover Amlodipine Besylate, and when can generic versions of Amlodipine Besylate launch?

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, 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, Alembic, Apotex, Dr Reddys, Neocubes Pharma, Amneal, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Heritage, Lupin Pharms, Rising, Teva Pharms, Watson Labs Inc, Hetero Labs, Macleods Pharms Ltd, Novel Labs Inc, Strides Pharma Intl, Teva Pharms Usa, Torrent, and Lupin Ltd. and is included in seventy-three NDAs.

The generic ingredient in AMLODIPINE BESYLATE is amlodipine besylate; hydrochlorothiazide; valsartan. There are fifty drug master file entries for this compound. Five 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:	56
NDAs:	73
Finished Product Suppliers / Packagers:	38
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	60
Patent Applications:	5,262
Drug Prices:	Drug price information 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

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 Labs Blu	AMLODIPINE BESYLATE	amlodipine besylate	TABLET;ORAL	207821-003	Jul 11, 2016	AB	RX	No	No
Hetero Labs	AMLODIPINE BESYLATE AND VALSARTAN	amlodipine besylate; valsartan	TABLET;ORAL	205137-002	Sep 16, 2016	AB	RX	No	No
Teva	AMLODIPINE BESYLATE	amlodipine besylate	TABLET;ORAL	076846-002	Jun 28, 2007	AB	RX	No	No
Mylan	AMLODIPINE BESYLATE AND VALSARTAN	amlodipine besylate; valsartan	TABLET;ORAL	090483-004	Mar 30, 2015	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	022026-003	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

International Patents for AMLODIPINE BESYLATE

See the table below for patents covering AMLODIPINE BESYLATE around the world.

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

Supplementary Protection Certificates for AMLODIPINE BESYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0678503	C300499	Netherlands		PRODUCT NAME: COMBINATIE OMVATTEND ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110114
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
0502314	SPC/GB11/010	United Kingdom		PRODUCT NAME: THE COMBINATION OF A) TELMISARTAN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, AND B) AMLODIPINE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, ESPECIALLY AMLODIPINE BESYLATE; REGISTERED: UK EU/1/10/648/001 20101007; UK EU/1/10/648/002 20101007; UK EU/1/10/648/003 20101007; UK EU/1/10/648/004 20101007; UK EU/1/10/648/005 20101007; UK EU/1/10/648/006 20101007; UK EU/1/10/648/007 20101007; UK EU/1/10/648/008 20101007; UK EU/1/10/648/009 20101007; UK EU/1/10/648/010 20101007; UK EU/1/10/648/011 20101007; UK EU/1/10/648/012 20101007; UK EU/1/10/648/013 20101007; UK EU/1/10/648/014 20101007; UK EU/1/10/648/015 20101007; UK EU/1/10/648/016 20101007; UK
0443983	C300445	Netherlands		PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016

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.

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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.