ACCURETIC Drug Patent Profile

When do Accuretic patents expire, and what generic alternatives are available?

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

The generic ingredient in ACCURETIC is hydrochlorothiazide; quinapril hydrochloride. There are thirty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; quinapril hydrochloride profile page.

Summary for ACCURETIC

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	128
Clinical Trials:	3
Patent Applications:	3,142
Drug Prices:	Drug price information for ACCURETIC
What excipients (inactive ingredients) are in ACCURETIC?	ACCURETIC excipients list
DailyMed Link:	ACCURETIC at DailyMed

See drug prices for ACCURETIC

Recent Clinical Trials for ACCURETIC

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

Sponsor	Phase
Ranbaxy Laboratories Limited	N/A
Mylan Pharmaceuticals	Phase 1

See all ACCURETIC clinical trials

Pharmacology for ACCURETIC

Drug Class	Angiotensin Converting Enzyme Inhibitor Thiazide Diuretic
Mechanism of Action	Angiotensin-converting Enzyme Inhibitors
Physiological Effect	Increased Diuresis

US Patents and Regulatory Information for ACCURETIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer Pharms	ACCURETIC	hydrochlorothiazide; quinapril hydrochloride	TABLET;ORAL	020125-001	Dec 28, 1999		DISCN	Yes	No
Pfizer Pharms	ACCURETIC	hydrochlorothiazide; quinapril hydrochloride	TABLET;ORAL	020125-002	Dec 28, 1999		DISCN	Yes	No
Pfizer Pharms	ACCURETIC	hydrochlorothiazide; quinapril hydrochloride	TABLET;ORAL	020125-003	Dec 28, 1999		DISCN	Yes	No

Expired US Patents for ACCURETIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer Pharms	ACCURETIC	hydrochlorothiazide; quinapril hydrochloride	TABLET;ORAL	020125-002	Dec 28, 1999
Pfizer Pharms	ACCURETIC	hydrochlorothiazide; quinapril hydrochloride	TABLET;ORAL	020125-002	Dec 28, 1999
Pfizer Pharms	ACCURETIC	hydrochlorothiazide; quinapril hydrochloride	TABLET;ORAL	020125-001	Dec 28, 1999
Pfizer Pharms	ACCURETIC	hydrochlorothiazide; quinapril hydrochloride	TABLET;ORAL	020125-003	Dec 28, 1999

International Patents for ACCURETIC

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

Country	Patent Number	Title	Estimated Expiration
Finland	79839
Germany	3176010
Hong Kong	43389	SUBSTITUTED ACYL DERIVATIVES OF 1,2,3,4-TETRAHYDROISOQUINOLINE-3-CARBOXYLIC ACIDS,SALTS THEREOF,PHARMACEUTICAL COMPOSITIONS CONTAINING THE DERIVATIVES OR SALTS,AND THE PRODUCTION OF THE SAME
New Zealand	198542	ACYL DERIVATIVES OF 1,2,3,4-TETRAHYDRO-ISOQUINOLINE-3-CARBOXYLIC ACID DERIVATIVES

Supplementary Protection Certificates for ACCURETIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0480717	98C0025	Belgium		PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
0502314	SPC/GB02/037	United Kingdom		PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419
0096157	SPC/GB95/011	United Kingdom		SPC/GB95/011:, EXPIRES: 20060930
0454511	SPC/GB99/008	United Kingdom		PRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE)(GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/98/086/001 19981015; UK EU/1/98/086/002 19981015; UK EU/1/98/086/003 19981015; UK EU/1/98/086/004 19981015; UK EU/1/98/086/005 19981015; UK EU/1/98/086/006 19981015

Market Dynamics and Financial Trajectory for the Drug: Accuretic

Introduction

Accuretic, a blood pressure medication, is part of the broader antihypertensive drugs market, which is highly competitive and influenced by various market dynamics. This article will delve into the market dynamics, financial trajectory, and other key factors affecting Accuretic.

Market Overview of Antihypertensive Drugs

The global antihypertensive drugs market is characterized by intense competition among major vendors such as AstraZeneca, Johnson & Johnson, Merck & Co., Novartis AG, and Pfizer Inc.[1].

• This market is driven by the rising prevalence of hypertension and heart failure, particularly in North America, where there is high awareness about the risk factors, prevention, diagnosis, and treatment of high blood pressure.

Role of ACE Inhibitors

Accuretic, which contains the ACE inhibitor quinapril and the diuretic hydrochlorothiazide, is a significant player in the ACE inhibitors segment.

• ACE inhibitors are crucial in managing hypertension, heart failure, and post-heart attack care. They also help in slowing kidney disease progression in diabetic patients and preventing cardiovascular events in high-risk individuals[3].

Market Size and Growth

The North America ACE Inhibitors Market, which includes drugs like Accuretic, was valued at USD 2.18 billion in 2023 and is expected to grow with a CAGR of 5.25% through 2029, reaching USD 2.93 billion by 2029[3].

• This growth is fueled by the increasing incidence of cardiovascular diseases, an aging population, and improvements in healthcare infrastructure.

Competitive Landscape

The market for ACE inhibitors, including Accuretic, is highly competitive with key players like Pfizer, Novartis, and AstraZeneca.

• These companies engage in intense competition through innovation, pricing strategies, and strategic collaborations. The competitive landscape drives the development of novel formulations, enhanced drug delivery mechanisms, and combination therapies[3].

Recall and Its Impact

In 2022, Pfizer recalled Accuretic due to elevated levels of nitrosamine, a chemical compound that can increase the risk of cancer. This recall had a significant impact on Pfizer's stock price, which fell by 2.1% following the announcement[4].

• The recall highlighted the importance of stringent quality control measures and the potential financial repercussions of such incidents.

Financial Impact

The recall of Accuretic led to a short-term financial impact on Pfizer, including a decline in stock price and potential losses from the recall process.

• However, the long-term financial trajectory of Pfizer and the broader antihypertensive drugs market is less likely to be significantly affected by a single recall, given the market's size and growth potential.

Revenue and Market Share

Despite the recall, Pfizer remains a major player in the antihypertensive drugs market. The company's overall revenue and market share are influenced by a diverse portfolio of drugs.

• For instance, Pfizer's revenue from other antihypertensive medications and its extensive product line helps mitigate the financial impact of a single drug recall[1].

Patient and Healthcare Provider Preferences

The market dynamics for Accuretic and other ACE inhibitors are also influenced by patient and healthcare provider preferences.

• Healthcare providers carefully evaluate the benefits and drawbacks of different antihypertensive drug classes to tailor treatment regimens that optimize patient outcomes. Patient education about potential adverse reactions and the importance of medication adherence is crucial for maintaining market share[3].

Combination Therapies

A significant trend in the ACE inhibitors market, including Accuretic, is the increasing adoption of combination therapies.

• Combining ACE inhibitors with other classes of antihypertensive medications can optimize treatment outcomes and provide unique value propositions to patients and healthcare providers[3].

Regulatory Environment

The regulatory environment plays a critical role in the market dynamics of Accuretic and other antihypertensive drugs.

• Regulatory bodies like the U.S. Food and Drug Administration (FDA) set strict standards for drug safety and efficacy, which pharmaceutical companies must adhere to. Compliance with these regulations is essential for maintaining market presence and avoiding financial penalties[4].

Future Outlook

Despite the recall, the future outlook for Accuretic and the broader ACE inhibitors market remains positive.

• Ongoing research and development efforts focus on enhancing existing drugs and developing novel therapies, which will continue to drive market growth. The increasing burden of cardiovascular diseases and improvements in healthcare infrastructure will also contribute to sustained growth in the market[3].

Key Takeaways

• Market Growth: The ACE inhibitors market, including Accuretic, is expected to grow with a CAGR of 5.25% through 2029.
• Competitive Landscape: The market is highly competitive, with major players like Pfizer, Novartis, and AstraZeneca.
• Regulatory Impact: The recall of Accuretic due to nitrosamine levels highlights the importance of regulatory compliance.
• Combination Therapies: The increasing adoption of combination therapies is a significant trend in the market.
• Patient Preferences: Healthcare providers and patient preferences play a crucial role in market dynamics.

FAQs

1. What is Accuretic used for?

   • Accuretic is used to treat hypertension and high blood pressure to reduce the risk of heart attacks or strokes.

2. Why was Accuretic recalled?

   • Accuretic was recalled due to elevated levels of nitrosamine, a chemical compound that can increase the risk of cancer.

3. How does the recall of Accuretic affect Pfizer's financials?

   • The recall led to a short-term decline in Pfizer's stock price and potential losses from the recall process, but the long-term financial impact is likely minimal.

4. What is the market size of the North America ACE Inhibitors Market?

   • The North America ACE Inhibitors Market was valued at USD 2.18 billion in 2023 and is expected to reach USD 2.93 billion by 2029.

5. What are the key drivers of the ACE inhibitors market?

   • The key drivers include the rising prevalence of cardiovascular diseases, an aging population, and improvements in healthcare infrastructure.

Sources

1. Top 5 Vendors in the Global Antihypertensive Drugs Market 2019-2023 - Business Wire
2. Quipt Home Medical Reports Third Quarter Fiscal 2024 Financial Results - Quipt Home Medical
3. North America ACE Inhibitors Market By Size, Share and Forecast - TechSci Research
4. Pfizer recalls blood pressure drug Accuretic, share price slides - Fortune
5. Blueprint Medicines Reports Fourth Quarter and Full Year 2022 - Blueprint Medicines