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:	80
Patent Applications:	2,041
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	020184-002	Dec 30, 1993	4,508,729
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	020184-001	Dec 30, 1993	5,162,362
Symplmed Pharms Llc	ACEON	perindopril erbumine	TABLET;ORAL	020184-002	Dec 30, 1993	5,162,362

International Patents for ACEON

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

Country	Patent Number	Title	Estimated Expiration
Denmark	383581
Denmark	157011
European Patent Office	0328160	Dérivés d'acides aminés, procédé pour leur préparation, moyens les contenant et leur utilisation. (Amino acid derivatives, process to prepare them, composition containing them and their use.)
Finland	812652
Norway	813339
Portugal	73584	AMINOSAEUREDERIVATE VERFAHREN ZU IHRER HERSTELLUNG DIESE ENTHALTENDE MITTEL UND DEREN VERWENDUNG
Spain	497517

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 ACE Inhibitors: A Focus on ACEON

Introduction

Angiotensin-Converting Enzyme (ACE) inhibitors, such as ACEON (perindopril erbumine), play a crucial role in the management of cardiovascular diseases, particularly hypertension and heart failure. This article delves into the market dynamics and financial trajectory of ACE inhibitors, with a specific focus on ACEON.

Market Size and Growth

The global ACE inhibitors market has been experiencing steady growth. In 2023, the market was valued at $6.9 billion and is projected to reach $7.24 billion in 2024, with a compound annual growth rate (CAGR) of 5.6% through 2028, reaching $9 billion[3].

North America Market

In North America, the ACE inhibitors market was valued at $2.18 billion in 2023 and is anticipated to grow with a CAGR of 5.25% through 2029, reaching $2.93 billion. This growth is driven by the increasing prevalence of cardiovascular diseases, an aging population, and advancements in healthcare infrastructure[1].

Key Market Trends

Increased Focus on Combination Therapies

Combination therapies, which involve combining ACE inhibitors with other antihypertensive medications, are gaining traction. This approach offers better treatment outcomes by targeting multiple pathways involved in blood pressure regulation[1].

Personalized Medicine Approaches

There is a significant shift towards personalized medicine, where treatments are tailored to individual patient characteristics such as genetics, comorbidities, and lifestyle factors. This trend emphasizes the importance of genetic testing and biomarker analysis to identify the most appropriate antihypertensive medication, including ACE inhibitors[1].

Segmental Insights

Dosage Forms

Oral tablets are the dominant dosage form for ACE inhibitors, including ACEON, due to their convenient administration, patient-friendly nature, and cost-effectiveness. These tablets provide accurate dosing and are readily accessible, promoting adherence to treatment plans[1].

Country Insights

The United States dominates the North America ACE inhibitors market due to its high prevalence of cardiovascular diseases, well-established healthcare infrastructure, and the presence of key pharmaceutical companies. The U.S. market is also driven by advanced medical research and a proactive regulatory environment[1].

Financial Implications

Cost Savings Through Evidence-Based Prescribing

Adherence to evidence-based prescribing guidelines can result in substantial cost savings. For instance, substituting higher-cost medications with lower-cost alternatives, such as generic ACE inhibitors, can reduce spending on antihypertensive medications significantly. A study found that such substitutions could decrease spending by $11.6 million in a single year, representing a 24% reduction in program spending[2].

Medicaid and Generic Pricing

The utilization of generic ACE inhibitors has significantly impacted the financial landscape. Medicaid data shows that generic products have exceeded brand utilization since 2006, leading to lower reimbursement costs. However, the average prices of brand ACE inhibitors continue to increase, despite the introduction of generics[4].

Competitive Landscape

Key Market Players

The ACE inhibitors market is highly competitive, with key players such as Pfizer, Novartis, AstraZeneca, Johnson & Johnson, and Merck KGaA. These companies are actively involved in drug production, distribution, and research and development to enhance existing drugs and develop novel therapies[1].

Recent Acquisitions and Expansions

AstraZeneca's acquisition of CinCor Pharma for $1.3 billion in January 2023 is a notable example of market expansion. This acquisition aims to enhance AstraZeneca's product line of aldosterone synthase inhibitors for treating resistant and uncontrolled hypertension[3].

Utilization and Expenditure

Historical Trends

From 1991 to 2021, the utilization of ACE inhibitors and angiotensin receptor blockers (ARBs) increased by 25%. Brand ACE inhibitors peaked in 2002, while generic products took over in 2006. Medicaid spent over $33.7 billion on ACE inhibitors and ARBs during this period[4].

Price Dynamics

The average reimbursement per prescription for brand ACE inhibitors and ARBs has increased sharply, despite the introduction of generics. This trend indicates ongoing pricing pressures and the need for cost-effective strategies in prescribing ACE inhibitors[4].

Regulatory and Safety Considerations

FDA Approvals and Labeling

ACEON (perindopril erbumine) has been evaluated for safety in numerous clinical trials. The FDA labeling highlights potential adverse effects such as cough, hypotension, and hyperkalemia, emphasizing the need for careful patient monitoring[5].

Postmarketing Experience

Postmarketing reports have included various adverse events, some of which are of unknown causal relationship to ACEON. These include cardiac arrest, eosinophilic pneumonitis, and acute renal failure, among others. This underscores the importance of continuous safety monitoring and regulatory updates[5].

Future Outlook

Growing Burden of Cardiovascular Diseases

The increasing incidence of cardiac disorders, such as coronary artery disease and heart failure, is expected to propel the growth of the ACE inhibitors market. As the global burden of cardiovascular diseases rises, the demand for effective treatments like ACE inhibitors will continue to grow[3].

Advancements in Combination Therapies

Ongoing research and development in combination therapies and personalized medicine approaches will further drive the market. These advancements aim to improve cardiovascular health and prevent complications, ensuring a promising future for ACE inhibitors[1].

Key Takeaways

• The ACE inhibitors market, including drugs like ACEON, is expected to grow significantly due to the rising burden of cardiovascular diseases.
• Combination therapies and personalized medicine approaches are key trends shaping the market.
• The North America market, particularly the U.S., dominates due to high disease prevalence and advanced healthcare infrastructure.
• Evidence-based prescribing and the use of generic ACE inhibitors can lead to substantial cost savings.
• The competitive landscape is driven by major pharmaceutical companies and recent acquisitions.

FAQs

What is the current market size of ACE inhibitors in North America?

The North America ACE inhibitors market was valued at $2.18 billion in 2023[1].

How is the ACE inhibitors market expected to grow in the future?

The market is anticipated to grow with a CAGR of 5.25% through 2029, reaching $2.93 billion[1].

What are the key trends in the ACE inhibitors market?

Key trends include the increased focus on combination therapies and personalized medicine approaches[1].

Which companies are major players in the ACE inhibitors market?

Major players include Pfizer, Novartis, AstraZeneca, Johnson & Johnson, and Merck KGaA[1].

What are the potential cost savings from using generic ACE inhibitors?

Substituting higher-cost medications with generic ACE inhibitors can reduce spending on antihypertensive medications by up to 42%[2].

Sources

1. North America ACE Inhibitors Market Trends, Competition, Opportunities - GlobeNewswire
2. Economic Implications of Evidence-Based Prescribing for Hypertension - JAMA Network
3. Global ACE Inhibitors Market Report 2024 - The Business Research Company
4. The Utilization, Expenditure, and Price of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers - PubMed
5. ACEON (perindopril erbumine) Label - FDA