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

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

International Patents for ACEON

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

Country	Patent Number	Title	Estimated Expiration
Australia	7594981
Luxembourg	88262
Japan	H0127061

Supplementary Protection Certificates for ACEON

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

Investment Scenario and Fundamentals Analysis for ACEON (Perphenazine)

Last updated: February 21, 2026

What is ACEON?

ACEON is a pharmaceutical product primarily marketed as an angiotensin-converting enzyme (ACE) inhibitor used to treat hypertension and certain types of chronic heart failure. Its active ingredient is ramipril, approved by the FDA in 1989 and marketed under the brand name ACEON among others. It has a generic presence and competes in the global antihypertensive market.

Market Overview and Competitive Position

Global Market Size

The global ACE inhibitor market was valued at approximately $17 billion in 2022. Projected to grow at a CAGR of 3.5% from 2023 to 2028, driven by increasing hypertension prevalence, aging populations, and expanding healthcare access.

Competitive Landscape

Major competitors include:

Brand Name	Active Ingredient	Market Share (2022)	Key Markets
Lisinopril	Lisinopril	35%	US, Europe, Asia
Ramipril	Ramipril	15%	Europe, Asia
Benazepril	Benazepril	10%	US, Latin America

ACEON’s generic ramipril faces price competition but benefits from established clinical use and prescriber familiarity.

FDA and Regulatory Status

• FDA approval: 1989 for hypertension, heart failure
• Current approval status: Approved, with extended labeling in some markets for use in diabetic nephropathy.
• Patents: The original patent expired in 2005. Generic versions are widely available.

Pricing and Revenue

Pricing Trends

• Brand-name ACEON: Average wholesale price (AWP) approximately $150 for a 30-day supply.
• Generic ramipril: AWP approximately $10–$15 for the same supply.

Revenue Estimations

• Competition has pressured prices downward, affecting margins.
• In 2022, global sales of ramipril-based drugs exceeded $1 billion, with ACEON contributing a minor share due to market saturation.

R&D and Pipeline

ACEON lacks a significant pipeline. Its generic status reduces R&D investment incentives. Future growth depends on lifecycle management, new formulations, or indications.

Patent and Generic Impact

Patents expired over a decade ago; the market is mature with numerous generics. Entry of biosimilars is not applicable, but biosimilar development is minimal given the small-molecule nature.

Regulatory and Market Entry Barriers

• Low to moderate. Generic manufacturers dominate.
• Patent litigation tendencies are minimal due to patent expiration years ago.
• Market penetration is saturated in developed markets; growth opportunities exist in emerging markets with expanding healthcare access.

Investment Risks

• Price erosion due to generic competition
• Regulatory shifts favoring new therapies
• Market saturation limits revenue growth
• Limited pipeline for ACEON or ramipril-related innovations

Key Financial Metrics (Estimates)

Metric	2022	Notes
Total global sales of ramipril drugs	~$1 billion	Market-wide
ACEON global revenue	Estimated <$100M	Brand dominance declined due to generics
Operating margins	15-20%	Pressured by low-priced generics
R&D expenditure	Minimal (~$5M annually)	Focused on lifecycle management, if any

Investment Outlook

• Short-term: Limited growth potential; price erosion in a saturated market.
• Long-term: Minimal upside absent new indications or formulations. The dominant players are generic companies with low margins.

Key Takeaways

• ACEON's core market is mature with widespread generic competition.
• Revenue and profit margins are under pressure from price declines.
• Limited pipeline reduces future growth prospects.
• Dominance in key markets is challenged by generic players.
• Opportunities might exist in emerging markets or through lifecycle extensions but are not substantial.

FAQs

1. Is ACEON a good investment in the current market?
It depends on the investor’s focus. Without pipeline advancements or new indications, financial returns are limited. The drug’s mature market status reduces upside potential.

2. What factors could improve ACEON’s market position?
Introduction of new formulations, approval for additional indications, or development of combination products could bolster revenue.

3. How does patent expiration impact ACEON’s valuation?
Patent expiration led to generic competition, greatly reducing pricing power and margins.

4. Are there opportunities in emerging markets?
Yes. Growing healthcare infrastructure and increasing hypertension awareness could create demand, although price competition remains fierce.

5. What are the main risks associated with ACEON investment?
Market saturation, declining prices, regulatory changes affecting generics, and minimal pipeline activity.

References

[1] MarketsandMarkets. (2022). ACE inhibitors Market Analysis.
[2] U.S. Food and Drug Administration. (2023). Drug Approvals and Labeling.
[3] EvaluatePharma. (2022). Global Pharmaceutical Market Data.