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Last Updated: January 7, 2025

PERINDOPRIL ERBUMINE Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Perindopril Erbumine

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

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Summary for PERINDOPRIL ERBUMINE
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SponsorPhase
Symplmed Pharmaceuticals LLCPhase 3
Roxane LaboratoriesN/A

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Pharmacology for PERINDOPRIL ERBUMINE
Medical Subject Heading (MeSH) Categories for PERINDOPRIL ERBUMINE
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
Ani Pharms PERINDOPRIL ERBUMINE perindopril erbumine TABLET;ORAL 078138-001 Nov 10, 2009 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aurobindo Pharma PERINDOPRIL ERBUMINE perindopril erbumine TABLET;ORAL 079070-001 Nov 10, 2009 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Apotex PERINDOPRIL ERBUMINE perindopril erbumine TABLET;ORAL 090463-001 Aug 30, 2010 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hikma PERINDOPRIL ERBUMINE perindopril erbumine TABLET;ORAL 090072-003 Nov 10, 2009 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aurobindo Pharma PERINDOPRIL ERBUMINE perindopril erbumine TABLET;ORAL 079070-002 Nov 10, 2009 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lupin Ltd PERINDOPRIL ERBUMINE perindopril erbumine TABLET;ORAL 078263-002 Jan 27, 2010 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ani Pharms PERINDOPRIL ERBUMINE perindopril erbumine TABLET;ORAL 078138-002 Nov 10, 2009 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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.

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