Perindopril erbumine - Generic Drug Details

What are the generic drug sources for perindopril erbumine and what is the scope of freedom to operate?

Perindopril erbumine is the generic ingredient in two branded drugs marketed by Symplmed Pharms Llc, Ani Pharms, Apotex, Aurobindo Pharma, Hikma, and Lupin Ltd, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for perindopril erbumine. One supplier is listed for this compound.

Summary for perindopril erbumine

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	6
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	3
Patent Applications:	3,186
Drug Prices:	Drug price trends for perindopril erbumine
What excipients (inactive ingredients) are in perindopril erbumine?	perindopril erbumine excipients list
DailyMed Link:	perindopril erbumine at DailyMed

See drug prices for perindopril erbumine

Recent Clinical Trials for perindopril erbumine

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Symplmed Pharmaceuticals LLC	Phase 3
Roxane Laboratories	N/A

See all perindopril erbumine clinical trials

Pharmacology for perindopril erbumine

Drug Class	Angiotensin Converting Enzyme Inhibitor
Mechanism of Action	Angiotensin-converting Enzyme Inhibitors

Medical Subject Heading (MeSH) Categories for perindopril erbumine

Angiotensin-Converting Enzyme Inhibitors

Antihypertensive Agents

Anatomical Therapeutic Chemical (ATC) Classes for perindopril erbumine

C09AA	ACE inhibitors, plain
C09A	ACE INHIBITORS, PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

Paragraph IV (Patent) Challenges for PERINDOPRIL ERBUMINE

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 perindopril erbumine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma	PERINDOPRIL ERBUMINE	perindopril erbumine	TABLET;ORAL	079070-001	Nov 10, 2009		RX	No	No
Symplmed Pharms Llc	ACEON	perindopril erbumine	TABLET;ORAL	020184-002	Dec 30, 1993		DISCN	Yes	No
Apotex	PERINDOPRIL ERBUMINE	perindopril erbumine	TABLET;ORAL	090463-001	Aug 30, 2010		DISCN	No	No
Ani Pharms	PERINDOPRIL ERBUMINE	perindopril erbumine	TABLET;ORAL	078138-003	Nov 10, 2009		DISCN	No	No
Apotex	PERINDOPRIL ERBUMINE	perindopril erbumine	TABLET;ORAL	090463-003	Aug 30, 2010		DISCN	No	No
Hikma	PERINDOPRIL ERBUMINE	perindopril erbumine	TABLET;ORAL	090072-003	Nov 10, 2009		DISCN	No	No
Lupin Ltd	PERINDOPRIL ERBUMINE	perindopril erbumine	TABLET;ORAL	078263-001	Jan 27, 2010		DISCN	No	No

Expired US Patents for perindopril erbumine

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	020184-002	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	020184-003	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	020184-002	Dec 30, 1993	4,508,729

Perindopril erbumine Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory of Perindopril Erbumine

Introduction to Perindopril Erbumine

Perindopril erbumine is a small molecule drug that targets the angiotensin-converting enzyme (ACE) and is primarily used in the treatment of cardiovascular diseases, including hypertension, heart failure, and stable coronary artery disease. Developed by Servier Pharma LLC, it has been a cornerstone in cardiovascular therapy since its global approval in 1988[4].

Market Growth and Outlook

The Perindopril Erbumine API Market has experienced significant growth in recent years and is projected to continue this upward trajectory. The market is expected to see sustained and substantial expansion from 2023 to 2031, driven by increasing demand for effective cardiovascular treatments[1].

Market Segmentation

The market is segmented based on type (purity ≥99% and purity <99%) and application (Perindopril Erbumine Tablets and others). Geographically, the market is divided into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. This segmentation helps in understanding the diverse market dynamics and opportunities across different regions and product types[1].

Key Drivers

Several factors drive the growth of the Perindopril Erbumine market:

• Increasing Prevalence of Cardiovascular Diseases: The rising incidence of hypertension, heart failure, and coronary artery disease globally fuels the demand for effective treatments like perindopril erbumine[4].
• Efficacy and Safety Profile: Perindopril erbumine has been demonstrated to reduce the risk of cardiovascular death, non-fatal myocardial infarction, and cardiac arrest, making it a preferred choice among healthcare providers[2][5].
• Long-Term Patient Adherence: Patients typically take perindopril erbumine over many years, ensuring a steady and predictable market demand[3].

Financial Performance

Perindopril erbumine has been a highly profitable product, particularly for Servier Pharma LLC. In the years 2006 and 2007, it generated annual global sales exceeding USD 1 billion, accounting for approximately 30% of Servier's total turnover. The product's high profitability is attributed to its high operating margins, which exceeded 90-100% during the period from 2000 to 2008[3].

Competitive Landscape

The market for ACE inhibitors, including perindopril erbumine, is competitive with several key players such as Les Laboratoires Servier SAS, CHIESI Farmaceutici SpA, and Viatris Inc. These companies are actively involved in research and development, driving innovation and competition in the market[4].

Generic Entry and Market Strategies

The entry of generic versions of perindopril erbumine has significant implications for the market. Servier employed strategies such as patent settlements and the development of a second-generation product (using the arginine salt instead of erbumine) to delay generic competition. This strategy involved switching patients to the new product and withdrawing the original product before generic versions could enter the market[3].

Regional Market Dynamics

The European Union, China, the United States, and Japan are key regions driving the development and consumption of ACE inhibitors. China, in particular, has shown significant progress in the development of these drugs, contributing to the overall market growth[4].

Challenges and Opportunities

While the market for perindopril erbumine is poised for growth, there are challenges to consider:

• Adverse Effects: The drug is associated with potential adverse effects such as angioedema, cough, and hypotension, which can impact patient compliance and market dynamics[2][5].
• Regulatory Environment: Changes in regulatory policies and patent laws can affect the market trajectory. For instance, the expiration of patents can lead to increased generic competition[3].

Future Outlook

The future outlook for perindopril erbumine remains positive, driven by the increasing need for effective cardiovascular treatments. The market is expected to expand significantly, with opportunities for further research and development in the ACE inhibitor segment. The competitive landscape will continue to evolve, with innovative drugs and strategies emerging to capture market share[1][4].

Key Takeaways

• Perindopril erbumine is a highly effective ACE inhibitor used in treating cardiovascular diseases.
• The market for perindopril erbumine is expected to grow substantially from 2023 to 2031.
• Key drivers include the increasing prevalence of cardiovascular diseases and the drug's efficacy and safety profile.
• The product has been highly profitable, with significant contributions to Servier's revenue.
• The market is competitive, with major players involved in R&D and strategic market maneuvers.
• Regional dynamics, particularly in the EU, China, the US, and Japan, play a crucial role in market growth.

Frequently Asked Questions

1. What is perindopril erbumine used for?

Perindopril erbumine is used for the treatment of patients with essential hypertension, stable coronary artery disease, and mild to moderate congestive heart failure[2][5].

2. Who developed perindopril erbumine?

Perindopril erbumine was developed by Servier Pharma LLC[4].

3. What are the potential side effects of perindopril erbumine?

Potential side effects include angioedema, cough, hypotension, and dizziness. In severe cases, angioedema can be life-threatening[2][5].

4. How has the market for perindopril erbumine performed financially?

The market for perindopril erbumine has been highly profitable, with annual global sales exceeding USD 1 billion in the past and operating margins of 90-100% during certain periods[3].

5. What strategies have been employed to manage generic competition for perindopril erbumine?

Servier has employed strategies such as patent settlements and the development of a second-generation product to delay generic competition and maintain market share[3].

Sources:

1. Market Research Intellect: Perindopril Erbumine API Market Size, Scope And Forecast Report.
2. Health Canada: PERINDOPRIL ERBUMINE Product Monograph.
3. European Commission: CASE AT.39612 – Perindopril (Servier).
4. Patsnap Synapse: Unleashing the Power of Perindopril Erbumine - A Comprehensive Review on R&D Breakthroughs.
5. Drugs.com: Perindopril: Package Insert / Prescribing Information.