QUINAPRIL HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for quinapril hydrochloride and what is the scope of freedom to operate?

Quinapril hydrochloride is the generic ingredient in two branded drugs marketed by Pfizer Pharms, Actavis Elizabeth, Actavis Labs Fl Inc, Ani Pharms, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Rx, Invagen Pharms, Lupin, Mylan, Norvium Bioscience, Prinston Inc, and Sun Pharm Inds Ltd, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for quinapril hydrochloride. Ten suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for QUINAPRIL HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	13
NDAs:	14
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	27
Patent Applications:	4,926
What excipients (inactive ingredients) are in QUINAPRIL HYDROCHLORIDE?	QUINAPRIL HYDROCHLORIDE excipients list
DailyMed Link:	QUINAPRIL HYDROCHLORIDE at DailyMed

Recent Clinical Trials for QUINAPRIL HYDROCHLORIDE

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

Sponsor	Phase
AHEPA University Hospital	Phase 4
University of Nebraska	Phase 4
Pfizer

See all QUINAPRIL HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for QUINAPRIL HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		EQ 10MG BASE	TABLET;ORAL
		EQ 5MG BASE	TABLET;ORAL
		EQ 40MG BASE	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for QUINAPRIL HYDROCHLORIDE

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

Anatomical Therapeutic Chemical (ATC) Classes for QUINAPRIL HYDROCHLORIDE

C09AA	ACE inhibitors, plain
C09A	ACE INHIBITORS, PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

US Patents and Regulatory Information for QUINAPRIL HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ani Pharms	QUINAPRIL HYDROCHLORIDE	quinapril hydrochloride	TABLET;ORAL	075504-003	Aug 24, 2007		DISCN	No	No
Ani Pharms	QUINAPRIL HYDROCHLORIDE	quinapril hydrochloride	TABLET;ORAL	075504-002	Aug 24, 2007		DISCN	No	No
Pfizer Pharms	ACCUPRIL	quinapril hydrochloride	TABLET;ORAL	019885-004	Nov 19, 1991		DISCN	Yes	No
Aurobindo Pharma Ltd	QUINAPRIL HYDROCHLORIDE	quinapril hydrochloride	TABLET;ORAL	202725-001	Apr 29, 2013	AB	RX	No	No
Ani Pharms	QUINAPRIL HYDROCHLORIDE	quinapril hydrochloride	TABLET;ORAL	075504-001	Aug 24, 2007		DISCN	No	No

Expired US Patents for QUINAPRIL HYDROCHLORIDE

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

QUINAPRIL HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Quinapril Hydrochloride

Introduction

Quinapril hydrochloride, marketed under the brand name Accupril, is an angiotensin-converting enzyme (ACE) inhibitor used primarily for the treatment of hypertension and heart failure. Understanding the market dynamics and financial trajectory of this drug is crucial for pharmaceutical companies, investors, and healthcare providers.

Mechanism of Action and Therapeutic Benefits

Quinapril hydrochloride is deesterified to its active metabolite, quinaprilat, which inhibits ACE activity. This inhibition reduces the conversion of angiotensin I to angiotensin II, a potent vasoconstrictor, thereby lowering blood pressure and reducing peripheral vascular resistance[3][5].

Market Size and Growth

The global quinapril hydrochloride market is expected to exhibit robust growth rates driven by increasing demand for antihypertensive medications. The positive momentum in market dynamics, combined with sustained expansion, indicates a likelihood of continued growth. Factors such as an aging population, rising prevalence of hypertension, and the need for effective blood pressure management contribute to this growth[4].

Competitive Landscape

The market for quinapril hydrochloride is influenced by the presence of generic and authorized generic versions. Authorized generics, which are brand-name drugs marketed and distributed by the brand manufacturer but under a generic label, play a significant role in pricing and competition. During the 180-day exclusivity period, the entry of an authorized generic can lower retail generic prices by 4-8% and wholesale prices by 7-14% compared to prices without authorized generic competition[2].

Pricing and Revenue Impact

The introduction of authorized generics significantly affects the revenues of first-filer generic companies. During the 180-day exclusivity period, the presence of an authorized generic can reduce the first-filer generic’s revenues by 40-52%. This impact persists even after the exclusivity period, with revenues 53-62% lower in the following 30 months[2].

Consumer Benefits

Consumers benefit from the competition introduced by authorized generics, as it leads to lower drug prices. For instance, the retail price of a generic drug during the 180-day exclusivity period can fall to 70% of the brand price with authorized generic competition, compared to 86% without it[2].

Long-Term Incentives and Patent Challenges

Despite the short-term revenue impact on generic companies, the long-term incentives for patent challenges remain robust. However, the expectation of authorized generic competition might deter generic companies from challenging patents on products with small sales, affecting decisions in markets with brand sales between $12 million and $27 million[2].

Regulatory and Legal Considerations

The use of authorized generics in patent litigation settlements is a significant factor. Brand-name companies may use agreements not to launch an authorized generic as a way to compensate independent generics in exchange for not challenging the patent. This practice can influence the competitive landscape and affect consumer prices[2].

Clinical and Economic Impact

Quinapril hydrochloride has been shown to reduce the risk of fatal and nonfatal cardiovascular events, such as strokes and myocardial infarctions, by lowering blood pressure. This therapeutic benefit translates into economic savings for the healthcare system by reducing the costs associated with managing and treating cardiovascular diseases[1].

Patient Population and Demographics

The therapeutic effects of quinapril hydrochloride are consistent across different age groups, including elderly patients. There is no increase in adverse events in elderly patients given the same daily dosages, making it a viable option for a broad patient population[5].

Side Effects and Safety Profile

While quinapril hydrochloride is generally well-tolerated, it can cause side effects such as angioedema, excessive hypotension, and renal function changes. These side effects are more pronounced in patients with preexisting renal impairment or heart failure. Periodic monitoring of renal function and white blood cell counts is recommended, especially in patients with collagen vascular disease and/or renal disease[1].

Pharmacokinetics and Metabolism

Quinapril hydrochloride is rapidly absorbed and extensively distributed to all tissues except the brain. It is hydrolyzed to quinaprilat, which is eliminated primarily by renal excretion. The elimination half-life of quinaprilat increases with decreasing creatinine clearance, necessitating dose adjustments in patients with renal insufficiency[5].

Conclusion

The market dynamics for quinapril hydrochloride are shaped by its therapeutic benefits, competitive landscape, and regulatory factors. While authorized generics introduce significant price competition, they also impact the revenues of generic companies. The long-term growth prospects for quinapril hydrochloride remain positive due to increasing demand for antihypertensive medications.

Key Takeaways

• Therapeutic Benefits: Quinapril hydrochloride effectively lowers blood pressure and reduces the risk of cardiovascular events.
• Market Growth: The global market is expected to grow due to increasing demand for antihypertensive drugs.
• Authorized Generics: These significantly lower prices and impact generic company revenues.
• Consumer Benefits: Lower prices benefit consumers, especially during the 180-day exclusivity period.
• Regulatory Considerations: Authorized generics play a role in patent litigation settlements.
• Safety Profile: The drug is generally well-tolerated but requires monitoring for side effects, especially in patients with renal impairment.

FAQs

Q: What is the primary use of quinapril hydrochloride? A: Quinapril hydrochloride is primarily used for the treatment of hypertension and heart failure.

Q: How does the introduction of authorized generics affect the market? A: Authorized generics lower prices and significantly reduce the revenues of first-filer generic companies during the 180-day exclusivity period and beyond.

Q: What are the potential side effects of quinapril hydrochloride? A: Potential side effects include angioedema, excessive hypotension, and changes in renal function, particularly in patients with preexisting renal impairment or heart failure.

Q: How is quinapril hydrochloride metabolized and eliminated? A: Quinapril hydrochloride is hydrolyzed to quinaprilat, which is eliminated primarily by renal excretion, with its elimination half-life increasing with decreasing creatinine clearance.

Q: What is the impact of quinapril hydrochloride on the healthcare system? A: By reducing the risk of fatal and nonfatal cardiovascular events, quinapril hydrochloride contributes to economic savings for the healthcare system.

Sources

1. Pfizer Medical Information - US: ACCUPRIL® (quinapril HCl)
2. Federal Trade Commission: Authorized Generic Drugs: Short-Term Effects and Long-Term Impact
3. PubMed: Quinapril: overview of preclinical data
4. Market Research Intellect: Global Quinapril Hydrochloride Market Size, Scope And Forecast Report
5. FDA: Accupril (Quinapril Hydrochloride Tablets) WARNING