ACEON Drug Patent Profile

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

Aceon is a drug marketed by Symplmed Pharms Llc and is included in one NDA.

The generic ingredient in ACEON is perindopril erbumine. There are fourteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the perindopril erbumine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Aceon

A generic version of ACEON was approved as perindopril erbumine by AUROBINDO PHARMA on November 10^th, 2009.

Summary for ACEON

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	84
Patent Applications:	2,241
What excipients (inactive ingredients) are in ACEON?	ACEON excipients list
DailyMed Link:	ACEON at DailyMed

Paragraph IV (Patent) Challenges for ACEON

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ACEON	Tablets	perindopril erbumine	2 mg, 4 mg and 8 mg	020184	1	2006-06-06

US Patents and Regulatory Information for ACEON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Symplmed Pharms Llc	ACEON	perindopril erbumine	TABLET;ORAL	020184-001	Dec 30, 1993		DISCN	Yes	No
Symplmed Pharms Llc	ACEON	perindopril erbumine	TABLET;ORAL	020184-002	Dec 30, 1993		DISCN	Yes	No
Symplmed Pharms Llc	ACEON	perindopril erbumine	TABLET;ORAL	020184-003	Dec 30, 1993		DISCN	Yes	No

Expired US Patents for ACEON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Symplmed Pharms Llc	ACEON	perindopril erbumine	TABLET;ORAL	020184-001	Dec 30, 1993	4,508,729
Symplmed Pharms Llc	ACEON	perindopril erbumine	TABLET;ORAL	020184-003	Dec 30, 1993	5,162,362
Symplmed Pharms Llc	ACEON	perindopril erbumine	TABLET;ORAL	020184-003	Dec 30, 1993	4,508,729
Symplmed Pharms Llc	ACEON	perindopril erbumine	TABLET;ORAL	020184-002	Dec 30, 1993	5,162,362
Symplmed Pharms Llc	ACEON	perindopril erbumine	TABLET;ORAL	020184-001	Dec 30, 1993	5,162,362
Symplmed Pharms Llc	ACEON	perindopril erbumine	TABLET;ORAL	020184-002	Dec 30, 1993	4,508,729

International Patents for ACEON

See the table below for patents covering ACEON around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	7594981
Finland	812652
Greece	75016
African Intellectual Property Organization (OAPI)	6914
Finland	90072
Japan	S5791974	IMINO DIACID COMPOUND, MANUFACTURE AND MEDICINAL COMPOSITION CONTAINING SAME AS ACTIVE COMPONENT

Supplementary Protection Certificates for ACEON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0049658	SPC/GB93/141	United Kingdom

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ACEON

Last updated: August 2, 2025

Introduction

ACEON, known generically as perindopril, is an angiotensin-converting enzyme (ACE) inhibitor primarily prescribed for hypertension and heart failure management. Since its initial approval, ACEON's market landscape has evolved significantly, influenced by global healthcare demands, regulatory changes, and competition from novel therapeutics. This article explores the key market drivers, competitive environment, regulatory landscape, and financial pathways that shape ACEON's current and future market trajectory.

Market Dynamics of ACEON

Global Epidemiology and Growing Demand

Hypertension remains a leading risk factor for cardiovascular diseases, affecting over 1.1 billion people globally. The rising prevalence driven by aging populations, sedentary lifestyles, and obesity amplifies demand for antihypertensive agents like ACEON. According to the Global Burden of Disease Study, cardiovascular disease incidence is projected to escalate, reinforcing ACEON's relevance in future therapeutics portfolios [1].

Competitive Therapeutic Landscape

While ACEON was among the pioneer ACE inhibitors, the market now features competing drugs such as enalapril, lisinopril, ramipril, and newer agents like ARBs (angiotensin receptor blockers) including losartan and valsartan. The competitive landscape is further complicated by the advent of combination therapies integrating ACE inhibitors with diuretics or calcium channel blockers, broadening treatment options.

However, ACEON benefits from established efficacy, safety profile, and clinician familiarity. The brand retains a niche, especially in markets where physicians prefer tried-and-tested medications. Proprietary formulations and patent protections have historically helped maintain some degree of market exclusivity.

Regulatory Environment and Patent Considerations

Originally approved decades ago, ACEON's patent protections have expired or are nearing expiration in multiple jurisdictions, leading to increased generic competition. Generics substantially reduce consumer costs but also exert price pressure on branded formulations. Regulatory agencies such as the FDA and EMA require ongoing post-market vigilance, especially concerning adverse effects linked to ACE inhibitors, influencing market access and prescribing habits.

Pricing, Market Access, and Reimbursement Trends

Pricing strategies are critical. In high-income markets like the U.S. and Europe, tiered reimbursement schemes, formulary placements, and insurance coverages influence ACEON's sales volume. Cost-effectiveness analyses favor ACE inhibitors over newer, more expensive agents, sustaining their use in resource-limited settings.

Implementation of value-based healthcare models increasingly emphasizes long-term outcomes and cost-effectiveness, providing opportunities for ACEON to maintain its footprint through strategic pricing and demonstrating economic benefits.

Emerging Market Dynamics

Emerging markets, including Asia-Pacific, Latin America, and parts of Africa, exhibit rapid growth in cardiovascular disease prevalence. Limited access to innovative, high-cost medications creates a demand for well-established generics like ACEON. Local manufacturing, price negotiations, and licensing agreements will shape these regions' contributions to the drug's global revenue.

Impact of Biosimilars and Combination Therapy Trends

The trend towards fixed-dose combinations (FDCs) and biosimilar development could influence ACEON’s viability. Although biosimilars are not directly applicable to small-molecule drugs like ACEON, FDCs incorporating ACE inhibitors are gaining favor for improving adherence, potentially impacting standalone ACEON sales.

Financial Trajectory and Profitability Factors

Historical Financial Performance

ACEON historically garnered robust revenues due to its early-mover advantage and widespread use. Peak sales occurred in the late 2000s, with global revenues exceeding USD 1 billion annually. Subsequent patent expirations led to a sharp decline in branded sales, replaced by generics which typically generate lower per-unit margins.

Current Revenue Streams

Presently, ACEON revenue predominantly stems from generic sales in developed countries and branded sales in emerging markets where generic penetration is slower. The revenue is highly sensitive to pricing pressures, regulatory approvals, and market penetration strategies.

R&D Investments and Pipeline Developments

Although ACEON itself is off-patent, ongoing R&D efforts focus on combination drugs and novel ACE inhibitors with improved safety, tolerability, or novel delivery mechanisms. A pipeline of such products can influence long-term revenue streams, either supplanted by existing generics or capturing automous market segments.

Market Challenges and Opportunities

Key challenges include pricing competition from generics, regulatory changes limiting prescribing flexibility, and emergence of alternative therapies. Conversely, opportunities exist in expanding indications (e.g., diabetic nephropathy), positioning in heart failure management, and leveraging digital health for adherence campaigns.

Financial Projections

Forecasts suggest a continued decline in ACEON sales in mature markets due to generic competition. However, in emerging markets where local manufacturers may delay generic entry, revenues could stabilize or grow modestly. Strategic licensing, mergers, or partnerships could also offer new revenue streams, offsetting declines in traditional markets.

Conclusion

The market and financial contexts of ACEON are emblematic of a mature, largely commoditized pharmaceutical product facing inevitable generic competition. Its future trajectory hinges on strategic positioning in emerging markets, development of combination therapies, and leveraging a global shift towards cost-effective cardiovascular management. While immediate prospects may be constrained for the core molecule, ancillary innovations and market expansion efforts offer pathways to sustain its relevance and profitability.

Key Takeaways

• Market demand for ACEON remains influenced by the global burden of hypertension and cardiovascular disease, especially in emerging markets.
• Generic competition significantly pressures pricing and revenue, particularly where patent protections have expired.
• Strategic expansion in emerging markets and development of combination therapies can mitigate revenue declines.
• Regulatory environments and reimbursement policies substantially influence access and profitability.
• Investments in R&D, especially in related therapeutic areas, could create new revenue avenues for the ACEON lineage.

FAQs

1. How does patent expiration impact ACEON’s market presence?
Patent expiration opens the market to generic manufacturers, drastically reducing prices and profit margins for the original product, while also increasing market share for lower-cost alternatives.

2. In which regions does ACEON see the highest demand today?
Emerging markets like India, China, and Latin America sustain higher demand levels due to limited generic penetration and healthcare infrastructure constraints favoring established therapies.

3. What is ACEON’s competitive advantage over newer antihypertensives?
Its long-standing safety profile, clinician familiarity, and established efficacy provide a comparative advantage, especially where cost containment influences prescribing.

4. Are there new formulations or combinations involving ACEON in development?
Yes, efforts focus on fixed-dose combinations with thiazide diuretics or calcium channel blockers, aiming to improve adherence and treatment outcomes.

5. What is the long-term outlook for ACEON’s profitability?
While core sales may decline in mature markets due to generic competition, strategic efforts—such as regional market expansion and product line diversification—could sustain profitability over the next decade.

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References

1. GBD 2019 Risk Factors Collaborators. "Global Burden of Disease Study 2019." The Lancet, 2020.