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. Ten 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:	85
Clinical Trials:	6
Patent Applications:	3,142
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

International Patents for ACCUPRIL

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

Country	Patent Number	Title	Estimated Expiration
Denmark	163120
Hong Kong	1006003
Ireland	880142
Hong Kong	59496	Stabilized pharmaceutical compositions containing angiotens in-converting enzyme inhibitors
Germany	3176029

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

ACCUPRIL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ACCUPRIL

Introduction

ACCUPRIL, also known as quinapril hydrochloride, 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 ACCUPRIL involves analyzing various factors, including competition, pricing, regulatory influences, and the broader pharmaceutical market.

Market Competition

The pharmaceutical market, particularly for ACE inhibitors, is highly competitive. ACCUPRIL competes with other ACE inhibitors such as captopril, enalapril, and lisinopril. The presence of generic versions of these drugs further intensifies the competition.

Authorized Generic Drugs

Authorized generic drugs (AGs) play a significant role in the market competition for ACCUPRIL. AGs are generic versions of brand-name drugs that are manufactured by the brand-name drug company itself or under a licensing agreement. The introduction of AGs can significantly lower prices and reduce revenues for independent generic competitors. For instance, during the 180-day exclusivity period, competition from AGs can lower retail generic prices by 4-8% and wholesale prices by 7-14% compared to prices without AG competition[1].

Pricing Dynamics

The pricing of ACCUPRIL and its generic counterparts is influenced by several factors, including competition, regulatory policies, and market demand.

Impact of Authorized Generics on Pricing

The presence of AGs during the 180-day exclusivity period can lead to lower prices for consumers. On average, the retail price of a generic drug during this period is 86% of the pre-entry brand price without AG competition and 82% with AG competition. Similarly, the wholesale price falls from 80% to 70% of the brand price with AG competition[1].

Long-Term Pricing

Over the long term, there is no evidence that AG prices are higher than those of other generics, allaying concerns that AGs might be less aggressive competitors. This suggests that the pricing of ACCUPRIL and its generic versions remains competitive even after the exclusivity period[1].

Financial Trajectory

The financial performance of ACCUPRIL and its generic versions is closely tied to the competitive landscape and pricing dynamics.

Revenue Impact on Generic Competitors

The introduction of AGs can significantly reduce the revenues of independent generic competitors. During the 180-day exclusivity period, the presence of an AG can reduce the first-filer generic’s revenues by 40-52%. This impact persists even after the exclusivity period, with revenues of the first-filer generic manufacturer being 53-62% lower in the 30 months following exclusivity[1].

Brand-Name Company Strategies

Brand-name companies may use agreements not to launch an AG as a way to compensate independent generics in exchange for not challenging the patent. This strategy can affect the financial trajectory by altering the timing and intensity of generic competition[1].

Regulatory Influences

Regulatory policies and approvals play a crucial role in shaping the market dynamics and financial trajectory of ACCUPRIL.

FDA Approvals and Labeling

ACCUPRIL is approved by the FDA for the treatment of hypertension and heart failure. Any changes in FDA labeling or approvals can impact its market position. For example, the use of ACCUPRIL in combination with thiazide diuretics is approved, which can influence prescribing patterns and market share[3][4].

Patent Challenges

The ability of generic companies to challenge patents affects the timing of generic entry. The presence of AGs can influence a generic company’s decision to challenge a patent, particularly for drugs with low sales. However, overall, patent challenges have remained robust despite the prevalence of AG competition[1].

Market Demand and Therapeutic Use

The demand for ACCUPRIL is driven by its therapeutic uses and the prevalence of the conditions it treats.

Hypertension and Heart Failure

ACCUPRIL is effective in reducing blood pressure and managing heart failure, which are significant health issues. The antihypertensive effect of ACCUPRIL continues during long-term therapy, with no evidence of loss of effectiveness. This consistent efficacy supports its market demand[3][4].

Combination Therapy

ACCUPRIL can be used alone or in combination with other medications, such as thiazide diuretics, which enhances its therapeutic value and market appeal[3][4].

Key Takeaways

• Competition: The market for ACCUPRIL is highly competitive, with significant impact from authorized generic drugs.
• Pricing: AGs lower prices during the 180-day exclusivity period and maintain competitive pricing long-term.
• Financial Trajectory: AGs reduce revenues for independent generic competitors, and brand-name companies use strategic agreements to manage competition.
• Regulatory Influences: FDA approvals and patent challenges are critical in shaping the market dynamics.
• Market Demand: Therapeutic efficacy and combination therapy options drive demand for ACCUPRIL.

FAQs

What is the impact of authorized generic drugs on the pricing of ACCUPRIL?

Authorized generic drugs lower retail generic prices by 4-8% and wholesale prices by 7-14% during the 180-day exclusivity period compared to prices without AG competition[1].

How do authorized generics affect the revenues of independent generic competitors?

The presence of an AG can reduce the first-filer generic’s revenues by 40-52% during the 180-day exclusivity period and by 53-62% in the 30 months following exclusivity[1].

What are the therapeutic uses of ACCUPRIL?

ACCUPRIL is indicated for the treatment of hypertension and the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis[3][4].

Can ACCUPRIL be used in combination with other medications?

Yes, ACCUPRIL can be used alone or in combination with thiazide diuretics, which enhances its therapeutic value[3][4].

How do regulatory policies influence the market dynamics of ACCUPRIL?

Regulatory policies, including FDA approvals and patent challenges, significantly influence the market dynamics by affecting the timing and intensity of generic competition and the use of combination therapies[1][3][4].

Sources

1. Federal Trade Commission. Authorized Generic Drugs: Short-Term Effects and Long-Term Impact.
2. Oregon Drug Use Review / Pharmacy & Therapeutics Committee. Oregon State Drug Review.
3. FDA. Accupril (Quinapril Hydrochloride Tablets) Label.
4. FDA. Accupril® (Quinapril Hydrochloride Tablets) Label.