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

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			Y	Y
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-003	Jan 21, 2015		DISCN	Yes	No			Y	Y
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-001	Jan 21, 2015		DISCN	Yes	No			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
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-002	Jan 21, 2015
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-003	Jan 21, 2015

International Patents for AMLODIPINE BESYLATE; PERINDOPRIL ARGININE

Country	Patent Number	Title	Estimated Expiration
Canada	2644467	FORME CRISTALLINE A DU SEL D'ARGININE DU PERINDOPRIL, SON PROCEDE DE PREPARATION, ET LES COMPOSITIONS PHARMACEUTIQUES QUI LA CONTIENNENT (A CRYSTALLINE FORM OF THE ARGININE SALT OF PERINDOPRIL, PROCESS FOR PREPARING IT, AND PHARMACEUTICAL COMPOSITIONS COMPRISING IT)
Slovenia	1989182
Ukraine	89905	α КРИСТАЛЛИЧЕСКАЯ ФОРМА АРГИНИНОВОЙ СОЛИ ПЕРИНДОПРИЛА, СПОСОБ ЕЕ ПОЛУЧЕНИЯ И ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, КОТОРАЯ ЕЕ СОДЕРЖИТ;α-КРИСТАЛІЧНА ФОРМА АРГІНІНОВОЇ СОЛІ ПЕРИНДОПРИЛУ, СПОСІБ ЇЇ ОДЕРЖАННЯ І ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ, ЯКА ЇЇ МІСТИТЬ (α-CRYSTALLINE FORM OF PERINDOPRIL ARGININE SALT, METHOD FOR MAKING SAME, AND PHARMACEUTICAL COMPOSITIONS CONTAINING SAME)
Georgia, Republic of	P20125433	α CRYSTALLINE FORM OF THE ARGININE SALT OF PERINDOPRIL, PROCESS FOR PREPARING IT, AND PHARMACEUTICAL COMPOSITIONS COMPRISING IT
European Patent Office	1989182	FORME CRISTALLINE DU SEL D'ARGININE DU PERINDOPRIL, SON PROCEDE DE PREPARATION, ET LES COMPOSITIONS PHARMACEUTIQUES QUI LA CONTIENNENT (CRYSTALLINE FORM OF THE ARGININE SALT OF PERINDOPRIL, PROCESS FOR PREPARING IT, AND PHARMACEUTICAL COMPOSITIONS COMPRISING IT)

Supplementary Protection Certificates for AMLODIPINE BESYLATE; PERINDOPRIL ARGININE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0503785	C300486	Netherlands		PRODUCT NAME: COMBINATIE VAN OLMESARTANMEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, AMLODIPINEBESYLAAT AND HYDROCHLOORTHIAZIDE; NATL REGISTRATION NO/DATE: RVG 106667, RVG 106671-74, RVG 106682-86 20101221; FIRST REGISTRATION: DE 79810.00.00-79814.00.00 20101216
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
0443983	C00443983/03	Switzerland		PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
1507558	2012/018	Ireland		PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705
0443983	2007C/043	Belgium		PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222

AMLODIPINE BESYLATE; PERINDOPRIL ARGININE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Amlodipine Besylate and Perindopril Arginine

Introduction

The combination of amlodipine besylate and perindopril arginine, often marketed as Viacoram or Prestalia, is a significant player in the antihypertensive market. This fixed-dose combination (FDC) of a calcium channel blocker (CCB) and an angiotensin-converting enzyme (ACE) inhibitor has been approved for the treatment of mild to moderate essential hypertension. Here, we delve into the market dynamics and financial trajectory of this combination.

Market Size and Growth

The global market for amlodipine besylate is substantial and growing. As of 2023, the market size was estimated at USD 1,867.0 million and is projected to reach USD 2,539.5 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 3.98% from 2024 to 2031[3].

Drivers of Market Growth

Several factors drive the growth of the amlodipine besylate market:

Rising Prevalence of Hypertension

The increasing prevalence of hypertension and cardiovascular diseases globally is a primary driver. According to the World Health Organization (WHO), approximately 1.28 million adults aged 30-79 in low and middle-income countries suffer from hypertension, with about 46% of these individuals unaware of their condition[3].

Combination Therapies

The adoption of combination therapies, such as the FDC of amlodipine besylate and perindopril arginine, enhances patient compliance and accessibility. These combinations often improve adherence, persistence, and outcomes compared to monotherapies[1][4].

Regulatory Approvals and Endorsements

Regulatory approvals and endorsements by health organizations play a crucial role in market expansion. The approval of new formulations, such as the combination of perindopril arginine and amlodipine besylate, further solidifies the market position of these medications[1][4].

Increasing Awareness and Healthcare Infrastructure

Growing awareness programs regarding cardiovascular health and the expansion of healthcare infrastructure, particularly in regions like North America and the Asia Pacific, contribute to the market's growth. Advanced healthcare systems, high healthcare spending, and widespread insurance coverage in North America ensure broad access to these medications[3].

Financial Trajectory

Cost Analysis

The financial trajectory of the FDC of perindopril arginine and amlodipine besylate is influenced by its cost relative to other antihypertensive treatments. At manufacturer-submitted prices, the daily cost of this combination ranges from $0.95 to $1.15 per patient, or $346.75 to $419.75 annually. This makes it more costly than perindopril erbumine and amlodipine used as monotherapy but generally less costly than the free-dose combination of these drugs[2][4].

Comparative Cost-Effectiveness

Compared to other ACE inhibitor/CCB combinations, perindopril arginine/amlodipine is less costly than combinations like verapamil/trandolapril but more expensive than some other FDCs with diuretics. It is also more expensive than ACE inhibitors, angiotensin receptor blockers (ARBs), and CCBs when used as monotherapy[2][4].

Regional Market Dynamics

North America dominates the amlodipine besylate market, accounting for around 34.56% of the global market share in 2023. The Asia Pacific region is expected to experience significant growth, driven by increasing awareness of cardiovascular health and government initiatives promoting preventive healthcare[3].

Sales Channels and Distribution

The market for amlodipine besylate is influenced by various sales channels, including hospital pharmacies, drug stores, and online retailers. The online retail segment is expected to grow significantly, with a CAGR of 4.67% from 2024 to 2031, driven by the convenience and accessibility offered by e-commerce platforms. The COVID-19 pandemic has accelerated this shift toward online purchasing, ensuring continuous access to essential medications[3].

Competitive Landscape

The amlodipine besylate market is characterized by a robust competitive landscape with numerous global and regional pharmaceutical companies. The expansion of the market is fueled by the availability of cost-effective generics, which intensifies competition and broadens patient access to these medications. However, fierce competition from generic drugs leads to price erosion and reduced profit margins for manufacturers, necessitating a focus on differentiating products through improved formulations and combination therapies[3].

Clinical Efficacy and Adverse Effects

Clinical trials have demonstrated the efficacy of the combination of perindopril arginine and amlodipine besylate in reducing blood pressure and the risk of major adverse cardiovascular events. The most common adverse effects include peripheral edema, cough, dizziness, and hypotension. More severe but less common adverse effects can include dose-dependent hyperkalemia, impairment of renal function, angioedema, and teratogenicity[1][5].

Conclusion

The market for amlodipine besylate and perindopril arginine is driven by a combination of factors including the rising prevalence of hypertension, the adoption of combination therapies, and regulatory approvals. While the financial trajectory shows that this FDC is more costly than some monotherapies but competitive with other combinations, its efficacy and patient compliance benefits make it an attractive option in the antihypertensive market.

Key Takeaways

• Growing Market Size: The global amlodipine besylate market is projected to grow from USD 1,867.0 million in 2023 to USD 2,539.5 million by 2031.
• Combination Therapies: The FDC of perindopril arginine and amlodipine besylate enhances patient compliance and outcomes.
• Cost-Effectiveness: More costly than some monotherapies but competitive with other combinations.
• Regional Dynamics: North America dominates, with significant growth expected in the Asia Pacific region.
• Sales Channels: Online retail segment growing due to convenience and accessibility.
• Clinical Efficacy: Demonstrated efficacy in reducing blood pressure and cardiovascular risk.

FAQs

What is the primary indication for the combination of perindopril arginine and amlodipine besylate?

The primary indication is for the treatment of mild to moderate essential hypertension in patients for whom combination therapy is appropriate.

How does the cost of perindopril arginine/amlodipine compare to other antihypertensive treatments?

It is more costly than perindopril erbumine and amlodipine used as monotherapy but generally less costly than the free-dose combination of these drugs and some other FDCs.

What are the common adverse effects of perindopril arginine/amlodipine?

Common adverse effects include peripheral edema, cough, dizziness, and hypotension.

How is the market for amlodipine besylate expected to grow in the coming years?

The market is expected to grow at a CAGR of 3.98% from 2024 to 2031, driven by the rising prevalence of hypertension and increasing adoption of combination therapies.

What role do online retail channels play in the distribution of amlodipine besylate?

Online retail channels are expected to grow significantly, driven by the convenience and accessibility they offer, and accelerated by the COVID-19 pandemic.

Sources

1. Perindopril arginine and amlodipine besylate for hypertension - PubMed[1]
2. CADTH CANADIAN DRUG EXPERT COMMITTEE FINAL RECOMMENDATION - CADTH[2]
3. Amlodipine Besylate Market Size & Share Forecast [2031] - Kings Research[3]
4. CDR Pharmacoeconomic Review Report for Viacoram - CADTH[4]
5. PRESTALIA® (perindopril arginine/amlodipine besylate) - FDA[5]