PERINDOPRIL ERBUMINE - Generic Drug Details

What are the generic 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:	84
Clinical Trials:	3
Patent Applications:	3,514
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
Apotex	PERINDOPRIL ERBUMINE	perindopril erbumine	TABLET;ORAL	090463-002	Aug 30, 2010		DISCN	No	No
Ani Pharms	PERINDOPRIL ERBUMINE	perindopril erbumine	TABLET;ORAL	078138-003	Nov 10, 2009		DISCN	No	No
Ani Pharms	PERINDOPRIL ERBUMINE	perindopril erbumine	TABLET;ORAL	078138-001	Nov 10, 2009		DISCN	No	No
Hikma	PERINDOPRIL ERBUMINE	perindopril erbumine	TABLET;ORAL	090072-002	Nov 10, 2009		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	020184-003	Dec 30, 1993
Symplmed Pharms Llc	ACEON	perindopril erbumine	TABLET;ORAL	020184-002	Dec 30, 1993
Symplmed Pharms Llc	ACEON	perindopril erbumine	TABLET;ORAL	020184-001	Dec 30, 1993
Symplmed Pharms Llc	ACEON	perindopril erbumine	TABLET;ORAL	020184-002	Dec 30, 1993

PERINDOPRIL ERBUMINE Market Analysis and Financial Projection

Last updated: February 6, 2026

What Are the Market Dynamics for Perindopril Erbumine?

Perindopril erbumine is an angiotensin-converting enzyme (ACE) inhibitor primarily indicated for hypertension and heart failure management. The drug enjoys a stable global market driven by increasing prevalence of cardiovascular diseases (CVD), expanding healthcare infrastructure, and stringent regulatory approvals.

Key Market Drivers

• Rising CVD Incidence: Globally, CVD remains the leading cause of death, with an estimated 19.5 million deaths annually according to WHO. Hypertension affects approximately 1.13 billion people, emphasizing the need for effective antihypertensives like perindopril.
• Screening and Diagnosis Expansion: Greater awareness and screening programs improve diagnosis, boosting prescription rates.
• Healthcare Policy and Regulation: Many countries, including those in Europe and parts of Asia, have integrated ACE inhibitors into their essential medicines lists, promoting consistent use.

Market Restraints

• Generic Competition: Perindopril erbumine's patent expired globally by 2015, leading to extensive generic manufacturing, reducing prices.
• Side Effect Profile: Known adverse effects such as cough, hyperkalemia, and angioedema limit usage in some patient groups.
• Alternative Therapies: Increasing adoption of alternative antihypertensives, including ARBs and calcium channel blockers, influences market share.

Geographic Market Overview

• Europe: Largest market share due to high prevalence of hypertension and strong healthcare infrastructure.
• Asia-Pacific: Rapid growth potential driven by urbanization and increasing CVD prevalence.
• North America: Mature market with high generic penetration and extensive healthcare coverage.

How is the Financial Trajectory Shaping Up for Perindopril Erbumine?

Post-patent expiry has led to price erosion, yet volume sales compensate, maintaining revenue streams. The global market for ACE inhibitors, including perindopril, was valued at approximately $2.8 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 3% between 2023 and 2028.

Revenue Projections

Year	Estimated Global Revenue (USD billion)	Growth Rate (%)
2023	2.84	1.4
2024	2.91	2.4
2025	3.00	3.1
2026	3.09	3.0
2027	3.18	2.9
2028	3.28	3.1

Key Market Participants

• AstraZeneca: Originator with ongoing branded sales, especially in Europe.
• Teva Pharmaceuticals: Major generic producer, with significant market share.
• Mylan (now part of Viatris): Also a prominent generics provider.

Pricing Trends

• Price erosion averages 8-12% annually across key markets post-2015 generic entry.
• High-volume markets sustain revenue despite lower per-unit prices.

What Are the Potential Opportunities and Risks?

Opportunities

• Development of fixed-dose combination therapies with diuretics or calcium channel blockers.
• Expansion into emerging markets with unmet hypertension treatment needs.
• Innovation in formulations (e.g., sustained-release) to improve adherence.

Risks

• Price competition from generics reducing margins.
• Regulatory restrictions due to safety concerns.
• Competition from newer antihypertensives with better tolerability profiles.

Key Takeaways

• The market for perindopril erbumine is stable but mature, with growth driven by rising hypertension prevalence.
• Revenue erosion from generics is offset by increased sales volume.
• Growth is projected to be modest, around 3% CAGR through 2028.
• Major players include AstraZeneca and global generics firms.
• Regional dynamics favor Europe and Asia-Pacific, with North America highly competitive.

FAQs

1. How has the patent expiry affected the market?
Patent expiry in 2015 led to widespread generic manufacturing, significantly reducing prices and margins but increasing overall sales volume.

2. What are the main competing drugs?
Angiotensin receptor blockers (ARBs) like losartan and valsartan, along with other classes such as calcium channel blockers, compete with perindopril.

3. Are there emerging therapies that threaten perindopril's market?
Yes, newer antihypertensives with better safety profiles and fixed-dose combinations are gaining popularity, potentially impacting perindopril's market share.

4. Which markets are most important for growth?
Europe remains key, but Asia-Pacific presents significant growth opportunities due to disease burden and expanding healthcare access.

5. What is the outlook for perindopril erbumine's revenue?
Expected to grow at 3% CAGR through 2028, driven by volume increases, despite pricing pressures.

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Sources
[1] WHO Cardiovascular Disease Data, 2022
[2] MarketWatch, "Global ACE Inhibitors Market," 2022
[3] IMS Market Insights, "Hypertension Treatment Market," 2022