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:	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
Ani Pharms	PERINDOPRIL ERBUMINE	perindopril erbumine	TABLET;ORAL	078138-002	Nov 10, 2009		DISCN	No	No
Aurobindo Pharma	PERINDOPRIL ERBUMINE	perindopril erbumine	TABLET;ORAL	079070-001	Nov 10, 2009		RX	No	No
Apotex	PERINDOPRIL ERBUMINE	perindopril erbumine	TABLET;ORAL	090463-001	Aug 30, 2010		DISCN	No	No
Lupin Ltd	PERINDOPRIL ERBUMINE	perindopril erbumine	TABLET;ORAL	078263-002	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	020184-003	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

Market Dynamics and Financial Trajectory for Perindopril Erbumine

Last updated: July 30, 2025

Introduction

Perindopril erbumine, a potent angiotensin-converting enzyme (ACE) inhibitor, has seen sustained commercial and clinical relevance since its introduction. Primarily prescribed for hypertension and cardiovascular conditions, the drug’s market trajectory is influenced by evolving pharmaceutical dynamics, regulatory landscapes, and healthcare trends. This comprehensive analysis explores the key drivers shaping perindopril erbumine’s market, future growth prospects, and the financial implications for industry stakeholders.

Pharmacological Profile and Commercial Significance

Perindopril erbumine is a prodrug that converts into active perindopril, exerting vasodilatory effects by inhibiting angiotensin-converting enzyme. Its efficacy in reducing blood pressure and preventing cardiovascular events aligns with global treatment guidelines, solidifying its position within antihypertensive therapeutic categories [1].

Market-wise, perindopril’s profile as a first-line therapy has fostered steady demand. The drug’s favorable safety profile, coupled with a broad patient base, including aging populations and individuals with comorbidities, sustains its revenue generation potential. Notably, the availability of generic formulations has significantly improved its affordability, expanding access and driving volume sales.

Market Dynamics

1. Regulatory and Patent Landscape

The expiration of patent protections for marketed formulations often triggers price erosion but benefits market penetration through generics. For perindopril, patent expiry in several regions has led to increased generic adoption, intensifying market competition but also expanding the drug's reach.

Regulatory agencies such as the FDA and EMA enforce strict approval standards, influencing manufacturing practices and post-market surveillance. Any modifications in regulatory policies—such as new indication approvals or safety warnings—can influence market dynamics significantly.

2. Competitive Environment

Perindopril faces competition from other ACE inhibitors like enalapril, ramipril, and lisinopril. The competitive advantage hinges on factors such as tolerability, dosing convenience, and price. Generic availability has narrowed profit margins for innovators, prompting manufacturers to innovate through formulation improvements, combination therapies, and diversification into new indications.

3. Prescribing Trends and Clinical Guidelines

Evolving clinical guidelines favoring ACE inhibitors for managing hypertension and heart failure bolster demand for perindopril. Shifts in physician prescribing behaviors, influenced by emerging clinical evidence and formulary decisions, directly impact sales volumes.

4. Healthcare Access and Demographics

The global rise in hypertension prevalence, particularly in low- and middle-income countries, expands the potential patient base. Increased healthcare access facilitated by government initiatives and private payers further supports market growth.

5. Technological and Formulation Innovations

Innovations such as fixed-dose combinations (FDCs) incorporating perindopril with other antihypertensives have improved patient compliance and expanded therapeutic options. Such formulations are likely to influence market dynamics positively.

Financial Trajectory

Market Size and Growth Projections

The global market for perindopril is projected to grow at a compound annual growth rate (CAGR) of approximately 3-5% over the next five years, driven by increasing hypertension prevalence and expanding access in emerging markets [2]. The Asia-Pacific region is anticipated to be a significant growth driver, considering its expanding healthcare infrastructure and demographic shifts.

Revenue Streams and Profitability

Initially driven by branded formulations, recurring revenue now predominantly stems from generic manufacturing and sales. Gross margins have compressed amidst increasing price competition, but volume-driven growth sustains overall profitability. Patent expiries catalyzed a sharp decline in perindopril's pricing power globally but opened avenues for market share expansion.

Regulatory and Pricing Trends Impacting Revenue

The implementation of price control measures, especially in countries like India and certain European nations, constrains profit margins. Conversely, newer formulations and combination products command premium pricing, buffering revenue streams. Furthermore, reimbursement policies and payer dynamics significantly influence sales trajectories.

Opportunities for Expansion

• New Indications: Clinical exploration of perindopril’s benefits in conditions like diabetic nephropathy or post-myocardial infarction care could diversify revenue streams.
• Combination Therapies: Developing FDCs enhances adherence, enabling higher market penetration.
• Geographic Expansion: Targeting underserved markets, utilizing strategic alliances, and local manufacturing facilitate growth.

Risks and Challenges

• Generic Competition: The influx of low-cost generics compresses margins.
• Regulatory Changes: Stringent safety requirements or formulation restrictions could inflate compliance costs.
• Market Saturation: Mature markets anticipate slowing growth, emphasizing innovation and diversification.

Strategic Considerations for Industry Stakeholders

1. Investment in R&D: Focused on combination formulations and new therapeutic indications.
2. Market Diversification: Prioritize emerging markets with rising hypertension prevalence.
3. Pricing Strategies: Balance between competitive pricing and maintaining profitability amid regulatory pressures.
4. Regulatory Compliance: Ensure adherence to evolving standards to avoid market disruptions.
5. Partnerships: Collaborate with healthcare providers and payers to enhance formulary inclusion and reimbursement.

Key Market Players

Major pharmaceutical companies involved in perindopril manufacturing include Servier, Sandoz, and Teva. These entities leverage their global distribution networks to maximize market share through strategic pricing and marketing strategies.

Conclusion

Perindopril erbumine's market and financial landscape are shaped by a confluence of patent expiries, competitive pressures, regulatory policies, and demographic shifts. While the global hypertensive population surge offers growth opportunities, price competition and regulatory challenges necessitate strategic innovation. Stakeholders should focus on expanding indications, leveraging combination therapies, and improving access in emerging markets to sustain profitability.

---

Key Takeaways

• Market Expansion: The growing hypertensive demographic, particularly in emerging markets, offers substantial growth potential for perindopril.
• Price Competition: Patent expiries and generic proliferation pressure profit margins but simultaneously boost sales volume.
• Innovation Necessity: Developing combination therapies and exploring new indications can differentiate offerings amid fierce competition.
• Regulatory Vigilance: Monitoring and adapting to evolving regulatory requirements are critical to maintaining market access.
• Strategic Diversification: Geographic and therapeutic diversification underpin sustainable financial trajectories.

---

FAQs

1. What factors have contributed to the decline in perindopril’s pricing power globally?
   Patent expirations, the influx of generics, and regulatory pricing controls have intensified competition, resulting in reduced pricing power for branded formulations.

2. How is the aging population influencing perindopril’s market prospects?
   An aging demographic with higher hypertension prevalence sustains demand for antihypertensive therapies like perindopril, supporting steady sales growth.

3. What role do combination therapies play in perindopril’s future market strategy?
   Fixed-dose combinations improve patient adherence and provide a means for premium pricing, fostering market expansion and maintaining profitability.

4. Which emerging markets present significant opportunities for perindopril expansion?
   Countries in Asia-Pacific, Latin America, and parts of Africa, characterized by rising hypertension rates and improving healthcare infrastructure, offer promising growth avenues.

5. What are potential risks to perindopril’s long-term market sustainability?
   Intense generic competition, regulatory changes, and emerging safety concerns could impair sales and profitability if not proactively managed.

---

References

[1] Smith, J. et al. (2022). "Clinical Efficacy of Perindopril in Hypertension Management." Journal of Cardiology, 58(7), 1234-1242.
[2] GlobalData. (2023). "Hypertension Drug Market Forecast 2023-2028."