Last Updated: June 17, 2026

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
US Patents:0
Applicants:5
NDAs:5
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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Aurobindo Pharma PERINDOPRIL ERBUMINE perindopril erbumine TABLET;ORAL 079070-001 Nov 10, 2009 RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Apotex PERINDOPRIL ERBUMINE perindopril erbumine TABLET;ORAL 090463-001 Aug 30, 2010 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hikma PERINDOPRIL ERBUMINE perindopril erbumine TABLET;ORAL 090072-003 Nov 10, 2009 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Last updated: February 17, 2026

What is Perindopril Erbumine?

Perindopril erbumine is an angiotensin-converting enzyme (ACE) inhibitor used primarily to treat hypertension and heart failure. It functions by relaxing blood vessels, which lowers blood pressure and reduces the workload on the heart. Approved treatments include monotherapy and combination therapy with other antihypertensives.

What is the Current Market Landscape?

The global ACE inhibitor market was valued at approximately $15 billion in 2022. It is expected to grow at a compound annual growth rate (CAGR) of around 3% from 2023 to 2030. Perindopril is among the leading drugs in this category, with key competitors including ramipril, enalapril, and lisinopril.

What Are the Key Therapeutic Attributes and Advantages?

Perindopril erbumine demonstrates a favorable safety profile, with common side effects including cough, dizziness, and hyperkalemia. Its pharmacokinetics feature once-daily dosing, which enhances patient compliance. Clinical trials show reductions in systolic blood pressure averaging 10–15 mmHg.

How is the Patent and Regulatory Environment?

The original patent for Perindopril erbumine expired in the U.S. in 2003 and in Europe in 2006. Several generic versions entered the market shortly afterward. Recently, regulatory agencies such as the FDA and EMA have approved new formulations and indications, including combination therapies. Still, patents covering specific formulations or delivery methods may hold exclusivity in certain markets until 2025-2030.

What Are the Market Penetration and Pricing Trends?

Generic versions significantly reduced per-unit costs globally. In entry markets like the U.S. and Europe, average retail prices for branded perindopril are roughly $20 per month, compared to $5–$8 for generics. Competition drives prices downward, impacting revenue and profitability projections.

What Are the Investment Opportunities?

The drug's long-standing clinical use supports steady demand. Opportunities exist in developing fixed-dose combinations (FDCs), such as perindopril with amlodipine or indapamide, which offer enhanced compliance. Orphan drug designation is unlikely due to widespread use.

Biotech and pharma companies could consider strategic licensing or partnership deals for formulations with improved bioavailability or novel delivery methods. Currently, no significant new molecular patents are active, but exclusivity may still derive from proprietary formulations or combination strategies.

What Are the Risks and Challenges?

Generic competition exerts downward pressure on prices. Patent expiries limit revenue potential beyond 2025. Regulatory delays or constraints could hinder approval of new formulations. Additionally, the drug faces competition from newer classes such as angiotensin receptor blockers (ARBs).

Safety concerns are minimal but include angioedema risks, especially in specific populations. Poor adherence, especially among elderly patients, remains an ongoing challenge impacting market size.

How Do Regulatory Trends Affect Investment?

Regulatory agencies have emphasized safety profile transparency in hypertension drugs. Post-marketing surveillance continues to monitor adverse events. Expanding indications—such as for diabetic nephropathy—are subject to approval processes but may expand market scope.

Emerging trends prioritize combination therapies, which could extend the product lifecycle of existing molecules. Regulatory pathways for FDCs are evolving, offering growth prospects.

What Are the Financial and R&D Fundamentals?

Perindopril erbumine's development costs were amortized long ago. Current revenues derive primarily from mature formulations. Future R&D investments focus on combination therapies, new formulations, or delivery systems.

Pharmacies and healthcare systems favor generics, pressuring pricing strategies. Contract manufacturing organizations (CMOs) and licensing partnerships remain vital to sustaining margins.

What Is the Outlook for the Market and Investment?

Steady demand driven by hypertension prevalence (estimated at 1.28 billion adults globally in 2023) supports sustained revenue streams. Market growth may be constrained by generic competition; however, niche segments like combination therapies or specific indications present growth avenues.

Investors should consider lifecycle management strategies—such as reformulations or new indications—to extend commercial viability. Entry points include licencing opportunities with early-stage formulations or partnering with companies holding FDC patents.

Key Takeaways

  • Perindopril erbumine has a well-established presence in the antihypertensive market with a global footprint.
  • Patent expiration and generic competition pressure revenues; opportunities exist in combination therapies and new formulations.
  • Regulatory landscapes favor safety and efficacy, with a focus on expanding indications.
  • Pricing is market-dependent, with generic options decreasing costs and profitability.
  • Future growth depends on lifecycle extension through innovation in delivery systems and combination drugs.

FAQs

1. What are the primary competitors to Perindopril erbumine?

Ramipril, enalapril, and lisinopril are the main competitors. They offer similar mechanisms with comparable efficacy and safety profiles.

2. How do patent expiries affect investment prospects?

Patent expiries have led to generic entry, reducing profits for original manufacturers. Opportunities shift toward combination drugs, formulations, or new indications.

3. Are there new formulation development opportunities?

Yes. Developing fixed-dose combinations and improved delivery systems such as sustained-release formulations offer promising avenues.

4. What regulatory considerations impact market expansion?

Regulatory agencies prioritize safety monitoring, approval of combination therapies, and indication expansion, which can facilitate or delay market growth.

5. Is there a significant pediatric or specialty market for Perindopril?

Limited data exist for pediatric use, but certain indications, like hypertensive nephropathy in diabetics, could open niche markets. Focus remains primarily on adult hypertension and heart failure.


[1] Market Research Future, 2022; FDA and EMA approval documents; Company filings.

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