Amlodipine besylate; perindopril arginine - Generic Drug Details

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

Amlodipine besylate; perindopril arginine is the generic ingredient in one branded drug marketed by Adhera and is included in one NDA. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Amlodipine besylate; perindopril arginine has thirty patent family members in twenty-seven countries.

Summary for amlodipine besylate; perindopril arginine

International Patents:	30
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Clinical Trials:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for amlodipine besylate; perindopril arginine
DailyMed Link:	amlodipine besylate; perindopril arginine at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for amlodipine besylate; perindopril arginine

Constraining patent/regulatory exclusivity:

7,846,961

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for amlodipine besylate; perindopril arginine

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

Sponsor	Phase
Symplmed Pharmaceuticals LLC	Phase 3

See all amlodipine besylate; perindopril arginine clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for amlodipine besylate; perindopril arginine

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

C09AA	ACE inhibitors, plain
C09A	ACE INHIBITORS, PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

Paragraph IV (Patent) Challenges for AMLODIPINE BESYLATE; PERINDOPRIL ARGININE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PRESTALIA	Tablets	amlodipine besylate; perindopril arginine	3.5 mg/2.5 mg, 7 mg/5 mg and 14 mg/10 mg	205003	1	2016-11-04

US Patents and Regulatory Information for amlodipine besylate; perindopril arginine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-002	Jan 21, 2015		DISCN	Yes	No	7,846,961		Y	Y
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-001	Jan 21, 2015		DISCN	Yes	No	7,846,961		Y	Y
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-003	Jan 21, 2015		DISCN	Yes	No	7,846,961		Y	Y

Expired US Patents for amlodipine besylate; perindopril arginine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-001	Jan 21, 2015	6,696,481
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-003	Jan 21, 2015	6,696,481
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-002	Jan 21, 2015	6,696,481

International Patents for amlodipine besylate; perindopril arginine

Country	Patent Number	Title	Estimated Expiration
Australia	2007220435
Brazil	PI0708278
Canada	2644467
China	101389603

Supplementary Protection Certificates for amlodipine besylate; perindopril arginine

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0443983	C00443983/03	Switzerland		PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
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
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
0503785	C300375	Netherlands		PRODUCT NAME: COMBINATIE VAN OLMESARTAN MEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN AMLODIPINEBESILAAT; REGISTRATION NO/DATE: RVG100984, RVG100986-87, RVG100989-91, RVG100993-95 20080819

Last updated: February 15, 2026

What are the current market dynamics for amlodipine besylate and perindopril arginine?

Amlodipine besylate and perindopril arginine are established antihypertensive agents with broad use across cardiovascular medicine. The global hypertension treatment market, valued at approximately $35 billion in 2022, is driven by increasing prevalence of hypertension, aging populations, and growing awareness of cardiovascular health.[1] Both drugs hold significant market share within this segment.

Market Drivers:

• Rising prevalence of hypertension globally, especially in developing economies.
• Expansion of aging populations susceptible to cardiovascular diseases.
• Increasing healthcare infrastructure investments in emerging markets.
• Patent expirations, leading to a rise in generic versions and price reductions.

Market Challenges:

• Competition from other antihypertensives such as ACE inhibitors, calcium channel blockers, and diuretics.
• Regulatory pressures around drug safety profiles.
• Price erosion driven by generic competition.

Regional Variations: North America remains the largest market due to high prescription rates and better healthcare access. Europe and Asia-Pacific show rapid growth rates, especially in countries with expanding healthcare coverage and increasing awareness efforts.

How are the financial trajectories of amlodipine besylate and perindopril arginine evolving?

The revenues for amlodipine and perindopril are primarily derived from generic sales, with global sales for amlodipine estimated at over $2 billion annually, primarily from generic versions and branded formulations.[2] Perindopril reports annual sales around $1 billion, with a substantial portion from generic sales.

Amlodipine Besylate:

• Market share decline in branded segments due to patent expiry in 2011.
• Revenue growth stabilized around $2 billion annually, driven by generic sales.
• Leading manufacturers include Teva, Mylan, and Sandoz.

Perindopril Arginine:

• Patent expired in 2010; generic competition increased thereafter.
• Annual revenue remains around $1 billion.
• Manufacturers such as Servier, Teva, and Sandoz dominate supply.

Pricing Trends:

• Price reductions of up to 60% since patent expiration.
• Price competition among generics impacts profit margins.
• Strategic branding and combination therapies aim to sustain revenue streams.

What impacts could future market trends for these drugs?

Patent and Regulatory Developments: Expiration dates for patents have led to a surge in generic availability, pressuring prices and margins. Any new formulation approvals or new indications could temporarily boost revenues.

Emergence of Combination Therapies: Combined antihypertensive drugs containing amlodipine or perindopril are gaining market share due to improved compliance. Companies investing in fixed-dose combinations may see increased sales.

Innovations and New Therapies: No recent significant innovations for these molecules threaten their market position currently. The focus remains on optimizing formulations and expanding indications.

Pricing policies and healthcare reforms in major markets could further influence revenues. Countries such as the US and members of the European Union enforce price controls, which could limit profit potential.

Can current market data predict future growth or decline?

Given the high prevalence of hypertension, demand for effective antihypertensive therapy will persist. However, market saturation for amlodipine and perindopril is likely, with modest growth driven primarily by population increases and treatment rate improvements. Competition from newer drugs or combination formulations could further challenge standalone amlodipine and perindopril sales.

In emerging markets, increased healthcare access may expand treatment rates, supporting growth, but price sensitivity remains a constraint.

Key Takeaways

• Market size for amlodipine and perindopril is stable, with revenues largely from generics.
• Patent expirations have driven significant price declines, reducing margins for manufacturers.
• Growing preference for combination therapies presents both challenges and opportunities.
• Regional variations influence sales performance, with high growth potential in Asia-Pacific.
• Future market trajectories depend on regulatory policies, innovation in formulations, and healthcare access expansions.

FAQs

1. How does patent expiration impact the market for amlodipine besylate?
Patent expiry in 2011 led to increased generic competition, reducing drug prices and revenue margins for brand-name producers.

2. Are there new formulations or indications for perindopril arginine?
No significant recent innovations or new indications. The primary focus is on optimizing existing formulations and exploring combination therapies.

3. Which regions are expected to drive future growth for these drugs?
Asia-Pacific, due to expanding healthcare infrastructure, and Latin America. Growth remains constrained in regions with strict price controls.

4. How do combination therapies affect sales of amlodipine and perindopril?
Fixed-dose combinations enhance compliance and treatment adherence, potentially increasing sales despite generic competition.

5. What regulatory trends could influence these drugs' market access?
Price regulations, reimbursement policies, and approval processes for generics and biosimilars shape the competitive landscape.

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Sources

[1] Global hypertension market data: MarketWatch, 2022.
[2] IQVIA. "Pharmaceutical Sales Data: Amlodipine Market Analysis," 2022.