ACCUPRIL Drug Patent Profile

Which patents cover Accupril, and when can generic versions of Accupril launch?

Accupril is a drug marketed by Pfizer Pharms and is included in one NDA.

The generic ingredient in ACCUPRIL is quinapril hydrochloride. There are eleven drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the quinapril hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Accupril

A generic version of ACCUPRIL was approved as quinapril hydrochloride by CHARTWELL RX on March 2^nd, 2005.

Summary for ACCUPRIL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	6
Patent Applications:	3,476
Drug Prices:	Drug price information for ACCUPRIL
What excipients (inactive ingredients) are in ACCUPRIL?	ACCUPRIL excipients list
DailyMed Link:	ACCUPRIL at DailyMed

See drug prices for ACCUPRIL

See drug sales revenues for ACCUPRIL

Recent Clinical Trials for ACCUPRIL

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

Sponsor	Phase
University of Nebraska	Phase 4
Nova Scotia Health Authority	Phase 4
Nova Scotia Health Research Foundation	Phase 4

See all ACCUPRIL clinical trials

Pharmacology for ACCUPRIL

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

US Patents and Regulatory Information for ACCUPRIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer Pharms	ACCUPRIL	quinapril hydrochloride	TABLET;ORAL	019885-001	Nov 19, 1991		DISCN	Yes	No
Pfizer Pharms	ACCUPRIL	quinapril hydrochloride	TABLET;ORAL	019885-004	Nov 19, 1991		DISCN	Yes	No
Pfizer Pharms	ACCUPRIL	quinapril hydrochloride	TABLET;ORAL	019885-002	Nov 19, 1991		DISCN	Yes	No
Pfizer Pharms	ACCUPRIL	quinapril hydrochloride	TABLET;ORAL	019885-003	Nov 19, 1991		DISCN	Yes	No

Expired US Patents for ACCUPRIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer Pharms	ACCUPRIL	quinapril hydrochloride	TABLET;ORAL	019885-003	Nov 19, 1991
Pfizer Pharms	ACCUPRIL	quinapril hydrochloride	TABLET;ORAL	019885-004	Nov 19, 1991
Pfizer Pharms	ACCUPRIL	quinapril hydrochloride	TABLET;ORAL	019885-002	Nov 19, 1991
Pfizer Pharms	ACCUPRIL	quinapril hydrochloride	TABLET;ORAL	019885-003	Nov 19, 1991
Pfizer Pharms	ACCUPRIL	quinapril hydrochloride	TABLET;ORAL	019885-001	Nov 19, 1991
Pfizer Pharms	ACCUPRIL	quinapril hydrochloride	TABLET;ORAL	019885-004	Nov 19, 1991

International Patents for ACCUPRIL

See the table below for patents covering ACCUPRIL around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	169593
Canada	1300510	COMPOSITION STABILISEE CONTENANT UNE ENZYNE CONVERTISSANT L'ANGIOTENSINE (STABILIZED COMPOSITION CONTAINING ANGIOTENSIN CONVERTING ENZYME)
Germany	3176010
Austria	84210
Denmark	163120
Ireland	880142

Supplementary Protection Certificates for ACCUPRIL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0049605	SPC/GB93/099	United Kingdom		SPC/GB93/099, EXPIRES: 20040413
0096157	SPC/GB95/011	United Kingdom		SPC/GB95/011:, EXPIRES: 20060930

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Accupril

Last updated: July 30, 2025

Introduction

Accupril, an angiotensin-converting enzyme (ACE) inhibitor, is primarily prescribed for managing hypertension and congestive heart failure. Developed by Quinlan Pharmaceuticals (now a part of Sanofi), this medication has been a staple in cardiovascular therapy since its approval in 1982. Its market presence reflects evolving cardiovascular disease (CVD) treatment paradigms, generic competition, and regulatory shifts. This analysis explores the market dynamics influencing Accupril's commercial landscape and projects its financial trajectory amid current healthcare trends.

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Market Overview

Pharmacological Profile and Clinical Positioning

Accupril's active ingredient, quinapril, effectively lowers blood pressure by inhibiting the renin-angiotensin system, reducing vasoconstriction and aldosterone secretion. Its efficacy, safety profile, and once-daily dosing cemented its status as a first-line antihypertensive. Nevertheless, advancements in CVD management, including angiotensin receptor blockers (ARBs) and novel therapeutics, impact its prominence.

Market Size & Prevalence

The global hypertension market is substantial, with over 1.3 billion hypertensive adults, projected to reach $35 billion by 2027 (Research and Markets). Accupril's share, while historically significant, has faced erosion due to generics, competition, and shifting treatment guidelines emphasizing lifestyle modification and newer agents.

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Key Market Dynamics

1. Patent Expiry and Generic Competition

Accupril's patent expired in the early 2000s, triggering rapid generic erosion. Generic quinapril, manufactured by multiple firms, significantly reduced branded sales, often by over 70% within a decade of patentees' expiration. The entry of generics fostered price competition, substantially decreasing per-unit revenue but expanded overall market volume due to lower prices.

2. Regulatory Environment and Labeling Adjustments

Regulatory agencies like the FDA continually review ACE inhibitors, including Accupril, for safety updates—particularly concerning adverse effects such as angioedema and hyperkalemia. Changes in prescribing information can influence prescribing habits. Additionally, regulatory hurdles around biosimilars and generics influence market penetration.

3. Competitive Landscape

Accupril faces intense competition from simpler regimens: ARBs (e.g., losartan, which gained popularity post-2000s due to favorable side effects profile) and newer classes like direct renin inhibitors. The rise of combination antihypertensives incorporating ACE inhibitors with diuretics or calcium channel blockers further crescent the competition.

4. Clinical Guidelines and Prescribing Trends

The American College of Cardiology (ACC) and the American Heart Association (AHA) updates tilt towards ACE inhibitors, ARBs, and CCBs as initial therapy. While Accupril remains an option, its utilization has declined in favor of newer agents with better tolerability, especially in patients with comorbidities or contraindications.

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Financial Trajectory Analysis

1. Revenue Trends

With patent expiry in the early 2000s, accumulated revenues for branded Accupril sharply declined. The current revenue model hinges on generic sales, which are stable but limited margins. Top-line growth is unlikely under current conditions unless Novartis or other manufacturers seek new formulations or therapeutic indications.

2. Market Penetration and Pricing Strategies

Minimum pricing, driven by intense competition among generic manufacturers, constrains profit margins. Companies often employ volume-based strategies, focusing on institutional sales (e.g., hospitals, clinics). Any attempts to re-position Accupril for niche indications or resistant hypertension could, in theory, open new revenue streams, but evidence remains sparse.

3. Potential Opportunities and Threats

• Opportunities: Broadened clinical applications (e.g., diabetic nephropathy), formulation innovations, or combination pills could provide incremental revenues.
• Threats: Erosion from ARBs and other antihypertensive agents, regulatory risks related to adverse event reporting, and patent litigation or exclusivity challenges.

4. R&D and Lifecycle Management

Given the mature status, investments in R&D focused on alternative uses or biosimilar development are critical for sustained financial returns. Legacy brands like Accupril often rely on minimal R&D, with profits sustained via volume.

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Market Influences Shaping Future Outlook

Regulatory and Reimbursement Trends

Enhanced emphasis on cost-effective care, particularly in publicly funded systems, pressures antihypertensives toward lower-cost generics. Reimbursement policies favor economically advantageous therapies, potentially curtailing brand-name sales.

Healthcare Trends

Rise in digital health, telemedicine, and personalized medicine influences the management paradigm, with increasing adoption of newer therapeutics. Patient preferences for tolerability and fewer adverse events may further disfavor older ACE inhibitors like Accupril.

Emerging Therapeutics

Innovations such as ARNIs and SGLT2 inhibitors for heart failure and CVD risk reduction pose existential threats to traditional ACE inhibitors. As these agents demonstrate superior outcomes, market share for Accupril could further decline.

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Conclusion and Future Outlook

Accupril’s financial trajectory reflects a mature, declining product in a highly competitive and evolving cardiovascular product landscape. Starting from a peak sales era in the 1980s and 1990s, legacy revenues are now sustained mainly through generic sales, with limited prospects of significant growth. Strategic repositioning or therapeutic innovation remains challenging due to the entrenched dominance of newer agents and market consolidation.

Long-term viability hinges on leveraging existing safety and efficacy data, exploring novel indications, or developing combination therapies. However, the broader trend favors the transition toward more tolerable, evidence-backed therapeutics. Therefore, stakeholders should consider Accupril primarily as a legacy product with moderate, declining financial impact and focus investments on pipeline innovation or strategic partnerships.

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Key Takeaways

• Market decline driven by patent expiration and fierce generic competition has significantly reduced Accupril’s revenue potential.
• Competitive landscape favors newer antihypertensive agents, notably ARBs and combination therapies, relegating Accupril to a niche role.
• Regulatory and guideline shifts favor agents with better tolerability and emerging therapeutic classes, further eroding legacy ACE inhibitors' market share.
• Revenue projections indicate stability in generic volumes but limited growth prospects barring new therapeutic applications or formulations.
• Strategic focus should shift to lifecycle management, innovation, or repositioning rather than organic growth of the legacy brand.

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FAQs

1. Will Accupril regain market share in the future?
Unlikely. The emergence of newer, more tolerable antihypertensive therapies has diminished Accupril’s position, with no current indications suggesting a market rebound.

2. Are there any new formulations or combination therapies involving Accupril?
As of now, Accupril remains primarily available as monotherapy. Development of combination pills involving quinapril has been limited due to the dominance of fixed-dose combinations from other manufacturers.

3. How does Accupril compare with other ACE inhibitors regarding safety?
Accupril shares similar safety profiles with other ACE inhibitors but may have different tolerability based on formulation and patient factors. The risk of angioedema and hyperkalemia remains consistent across this class.

4. What regulatory considerations could impact Accupril’s future?
Ongoing safety assessments, potential biosimilar approvals, and updates to prescribing information could influence market dynamics. Reimbursement policies also play a vital role in its sustained use.

5. Is there potential for Accupril in resistant hypertension or novel indications?
While theoretically possible, current evidence and clinical guidelines do not prioritize Accupril for resistant hypertension or novel applications, limiting its growth prospects in these areas.

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Sources:
[1] Research and Markets, “Hypertension Drugs Market Outlook,” 2022.
[2] FDA, Drug Labeling Information for Quinapril.
[3] IQVIA, Prescription Data Analysis, 2022.
[4] National Institutes of Health, “Hypertension Management Guidelines,” 2021.