PRESTALIA Drug Patent Profile

When do Prestalia patents expire, and what generic alternatives are available?

Prestalia is a drug marketed by Adhera and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has thirty patent family members in twenty-seven countries.

The generic ingredient in PRESTALIA is amlodipine besylate; perindopril arginine. There are fifty drug master file entries for this compound. Additional details are available on the amlodipine besylate; perindopril arginine profile page.

DrugPatentWatch^® Generic Entry Outlook for Prestalia

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 5, 2029. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for PRESTALIA

International Patents:	30
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PRESTALIA
What excipients (inactive ingredients) are in PRESTALIA?	PRESTALIA excipients list
DailyMed Link:	PRESTALIA at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for PRESTALIA

NDA:

205003

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.

Paragraph IV (Patent) Challenges for PRESTALIA

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 PRESTALIA

PRESTALIA is protected by one US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	205003-001	Jan 21, 2015		DISCN	Yes	No			Y	Y
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

Expired US Patents for PRESTALIA

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	205003-003	Jan 21, 2015
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-002	Jan 21, 2015

International Patents for PRESTALIA

When does loss-of-exclusivity occur for PRESTALIA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

France

Georgia, Republic of

Hong Kong

Hungary

Japan

Malaysia

Montenegro

Morocco

New Zealand

Norway

Poland

Serbia

Slovenia

South Africa

South Korea

Spain

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering PRESTALIA around the world.

Country	Patent Number	Title	Estimated Expiration
Slovenia	1989182
Japan	3737488
New Zealand	570367	A crystalline form of the arginine salt of perindopril, process for preparing it, and pharmaceutical compositions comprising it
Australia	2003200700
Poland	1989182
Australia	2007220435
Canada	2644467

Supplementary Protection Certificates for PRESTALIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0502314	C300478	Netherlands		PRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN AMLODIPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER AMLODIPINEBESILAAT; REGISTRATION NO/DATE: EU/1/10/648/001-028 20101007
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
0443983	C300445	Netherlands		PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
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
1003503	05C0048	France		PRODUCT NAME: AMLODIPINE OU UN DE SES SELS D?ADDITION D?ACIDES PHARMACAUTIQUEMENT ACCEPTABLES/ ATORVASTATINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: NL 29929 DU 20050707; REGISTRATION NO/DATE AT EEC: NL 29929 DU 20050707
1507558	C300528	Netherlands		PRODUCT NAME: COMBINATIE VAN ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; NATL. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705
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

Market Dynamics and Financial Trajectory for Prestalia

Last updated: July 29, 2025

Introduction

Prestalia (perindopril arginine with amlodipine) is a combination antihypertensive medication approved for the treatment of hypertension and chronic stable angina. The drug synergizes the actions of an ACE inhibitor (perindopril) and a calcium channel blocker (amlodipine), offering an effective alternative for patients inadequately controlled on monotherapy. As cardiovascular diseases continue to be a leading global health concern, understanding Prestalia’s market dynamics and financial trajectory is critical for stakeholders—including pharmaceutical companies, investors, healthcare payers, and policymakers.

Market Overview

The hypertension market remains among the largest segments within cardiovascular therapeutics, driven by the rising prevalence of high blood pressure globally. The World Health Organization (WHO) estimates approximately 1.28 billion adults worldwide suffer from hypertension, with numbers projected to increase due to aging populations and lifestyle factors such as obesity and poor diet (1). Innovative combination medications like Prestalia are instrumental in addressing unmet needs for effective blood pressure management, especially among patients requiring multi-drug therapy.

Competitive Landscape

Prestalia operates in a highly competitive arena with existing multi-drug formulations from companies such as Novartis, AstraZeneca, and Novo Nordisk. Notably, fixed-dose combinations (FDCs) of ACE inhibitors and calcium channel blockers have demonstrated improved patient adherence and therapeutic outcomes, thus gaining widespread acceptance (2). The key competitors include drugs like Exforge (amlodipine and valsartan) and Lotrel (amlodipine and benazepril).

Regulatory Status & Market Penetration

Initially approved in Europe and select territories, Prestalia's market penetration has been moderate due to the conservative adoption of generic and branded combination therapies. Regulatory pathways for FDCs are becoming more streamlined, which could accelerate their market entry and acceptance, especially given the global shift toward personalized and combination therapies.

Market Dynamics

Drivers

1. Rising Hypertension Prevalence

   The escalating burden of hypertension, particularly in emerging markets like Asia and Latin America, underscores the need for effective combination therapies. As awareness and diagnosis rates improve, demand for drugs like Prestalia is expected to grow.

2. Cardiovascular Risk Management

   There is an increasing emphasis on comprehensive cardiovascular risk management, with clinicians favoring multi-mechanistic approaches provided by fixed-dose combinations, which improve adherence and reduce pill burden.

3. Regulatory Incentives for FDCs

   Governments and regulatory agencies are increasingly encouraging the development and approval of fixed-dose combinations. The U.S. FDA has streamlined approval pathways for FDCs, fostering opportunities for Prestalia’s expansion (3).

4. Market Expansion in Developing Economies

   Growing healthcare infrastructure and rising investment in cardiovascular health initiatives in nations like India, China, and Brazil present substantial growth avenues for Prestalia, especially if priced competitively and supported by local manufacturing.

Challenges

1. Pricing and Reimbursement Barriers

   Cost concerns in both developed and developing markets may hinder access, particularly where healthcare systems are heavily cost-conscious. Reimbursement policies influence prescribing patterns significantly.

2. Generic Competition

   The widespread availability of generic monotherapies and FDCs can pressure pricing and market share of Prestalia, necessitating differentiation through clinical superiority or enhanced patient adherence.

3. Physician Prescribing Habits

   Prescriber familiarity with existing therapies and regulatory approvals influence the uptake rate. Overcoming clinical inertia remains a challenge.

4. Patent Expirations and Patent Cliff

   While Prestalia's patent protection provides exclusivity, upcoming patent expirations on key components (e.g., amlodipine, perindopril) can impact sales unless supplemental protections or formulations are introduced.

Emerging Trends

• Personalized medicine and biomarker-driven therapies are reshaping hypertension management, potentially limiting the scope of broad-spectrum combination drugs.

• The advent of digital health solutions is improving patient adherence, which can positively influence prescription volumes of drugs like Prestalia.

• Pharmacoeconomic research emphasizing the cost-effectiveness of combination therapies bolsters the case for Prestalia’s market growth.

Financial Trajectory

Revenue Projections

Given the current market landscape, Prestalia’s revenue outlook hinges on several key factors:

• Market Penetration Rate: The adoption rate will depend on geographic expansion, physician awareness, and formulary inclusions.

• Pricing Strategy: Competitive pricing aligned with generics, or premium positioning based on clinical benefits, will shape revenue streams.

• Regulatory Developments: Approvals in high-growth markets and securing formulary placements will enhance revenue potential.

• Lifecycle Management: Introduction of new formulations, dosage variations, or expanded indications can stoke revenues.

Economic Impact of Competition

Generic versions of the individual components, perindopril and amlodipine, have commoditized portions of the market, pressuring branded combination drugs’ prices. However, if Prestalia can demonstrate superior efficacy, tolerability, or adherence benefits, it may justify a premium price point.

Investment and Funding

Pharmaceutical firms investing in Prestalia’s manufacturing, marketing, and clinical research anticipate steady growth opportunities, especially with emerging data supporting its use in high-risk hypertensive populations. Strategic collaborations or licensing agreements could further augment financial prospects.

Potential for Market Expansion

• Developed Markets: Continued medical guideline updates favoring combination therapies will sustain demand, with Reimbursements playing a pivotal role.

• Emerging Markets: Rapid urbanization and healthcare access improvements forecast buoyant growth, especially if local regulatory pathways are navigated effectively.

Risks and Uncertainties

• Regulatory Delays or Rejections: May hinder market entry or expansion plans.
• Pricing Pressures: Revenue could be impacted by aggressive discounting or policy shifts favoring generics.
• Market Saturation: In mature markets, growth may plateau unless differentiated through novel indications or formulations.

Conclusion

The financial and market trajectory for Prestalia is poised for growth, driven by a confluence of rising hypertension prevalence, favorable regulatory trends, and the expanding acceptance of fixed-dose combination therapies. Competitor dynamics and pricing pressures present ongoing challenges; however, strategic positioning, efficient lifecycle management, and targeted market expansion can elicit substantial financial gains.

Key Takeaways

• Growing Demand: The global hypertension burden underpins long-term demand for combination therapies like Prestalia.
• Competitive Edge: Demonstrating superior adherence, efficacy, or safety can differentiate Prestalia amidst generic competition.
• Market Expansion: Emerging economies offer significant opportunities if access and pricing strategies are optimized.
• Regulatory Environment: Favorable policies for FDCs can accelerate market growth.
• Innovation & Lifecycle Management: Introducing new formulations or indications can sustain revenue streams and extend product relevance.

FAQs

1. What are the primary advantages of Prestalia over monotherapy options?
Prestalia combines an ACE inhibitor with a calcium channel blocker, providing superior blood pressure control, reduced pill burden, and improved patient adherence, especially in patients requiring multi-drug therapy.

2. How does Prestalia differentiate itself in a crowded antihypertensive market?
Its fixed-dose combination formulation, proven efficacy, tolerability profile, and potential for improved adherence serve as key differentiators, alongside clinical evidence supporting its use.

3. What are the main barriers to Prestalia’s global market expansion?
Pricing and reimbursement constraints, competition from generic alternatives, clinician prescribing inertia, and regulatory approval processes are significant barriers.

4. How might emerging trends in personalized medicine impact Prestalia’s market?
Personalized approaches may reduce reliance on broad-spectrum combination drugs, favoring tailored therapies. However, ongoing evidence of enhanced outcomes with FDCs can sustain relevance.

5. What strategies could enhance Prestalia’s financial future?
Expanding into new markets, optimizing pricing strategies, demonstrating cost-effectiveness, and launching improved formulations or indications can bolster its market position and revenue streams.

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Sources:

[1] WHO. “Hypertension.” World Health Organization, 2021.
[2] Williams, B. et al. “Impact of Fixed-Dose Combinations in Hypertension: Clinical and Economic Perspectives.” Cardiovascular Therapeutics, 2020.
[3] US FDA. “Guidance for Industry: Fixed-Dose Combination Products,” 2018.