QUINIDINE GLUCONATE - Generic Drug Details

What are the generic sources for quinidine gluconate and what is the scope of freedom to operate?

Quinidine gluconate is the generic ingredient in six branded drugs marketed by Lilly, Warner Chilcott, Bayer Hlthcare, Chartwell Molecular, Watson Labs, Ani Pharms, Ascot, Cycle, Halsey, Hibrow Hlthcare, Rising, Sun Pharm Industries, and Superpharm, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for quinidine gluconate. Four suppliers are listed for this compound.

Summary for QUINIDINE GLUCONATE

US Patents:	0
Tradenames:	6
Applicants:	13
NDAs:	16
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	40
Patent Applications:	2,223
Drug Prices:	Drug price trends for QUINIDINE GLUCONATE
What excipients (inactive ingredients) are in QUINIDINE GLUCONATE?	QUINIDINE GLUCONATE excipients list
DailyMed Link:	QUINIDINE GLUCONATE at DailyMed

See drug prices for QUINIDINE GLUCONATE

Pharmacology for QUINIDINE GLUCONATE

Drug Class	Antiarrhythmic Cytochrome P450 2D6 Inhibitor
Mechanism of Action	Cytochrome P450 2D6 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for QUINIDINE GLUCONATE

C01BA	Antiarrhythmics, class Ia
C01B	ANTIARRHYTHMICS, CLASS I AND III
C01	CARDIAC THERAPY
C	Cardiovascular system

US Patents and Regulatory Information for QUINIDINE GLUCONATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	QUINACT	quinidine gluconate	TABLET;ORAL	085978-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Watson Labs	QUINIDINE GLUCONATE	quinidine gluconate	TABLET, EXTENDED RELEASE;ORAL	087785-001	Jan 24, 1983		DISCN	No	No
Chartwell Molecular	QUINALAN	quinidine gluconate	TABLET, EXTENDED RELEASE;ORAL	088081-001	Feb 10, 1986		DISCN	No	No
Superpharm	QUINIDINE GLUCONATE	quinidine gluconate	TABLET, EXTENDED RELEASE;ORAL	089164-001	Nov 21, 1985		DISCN	No	No

QUINIDINE GLUCONATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Quinidine Gluconate

Introduction

Quinidine gluconate, a derivative of quinine, is a multifaceted drug with applications in both antimalarial and antiarrhythmic therapies. Understanding its market dynamics and financial trajectory is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Size and Growth

The market for quinidine gluconate is part of the broader quinine market, which is projected to grow significantly. By 2032, the quinine market is expected to reach USD 3.21 billion, growing at a Compound Annual Growth Rate (CAGR) of 5.81%[1].

Product Types and Applications

Quinidine gluconate is available in various forms, including extended-release tablets. It is primarily used for:

• Malaria Treatment: Although less common due to the emergence of more effective antimalarials, quinidine gluconate remains an option in certain cases.
• Antiarrhythmic Therapy: It is used to restore normal sinus rhythm in patients with atrial fibrillation/flutter and to suppress ventricular arrhythmias[2][4].
• Other Applications: It is also used in treating conditions like nocturnal leg cramps and restless legs syndrome.

Distribution Channels

The distribution of quinidine gluconate occurs through various channels, including:

• Pharmacies: Retail pharmacies are a primary point of sale.
• Hospitals: Quinidine gluconate is often prescribed and administered in hospital settings.
• Online Retailers: Increasingly, patients are purchasing medications online.
• Wholesalers: Bulk purchases are made through wholesalers for distribution to pharmacies and hospitals[1].

Regional Market Analysis

The market for quinidine gluconate is segmented geographically into:

• North America: A significant market due to advanced healthcare infrastructure.
• Europe: Another major market with a high demand for antiarrhythmic drugs.
• Asia-Pacific: Growing rapidly due to increasing healthcare needs and economic development.
• South America, Middle East, and Africa: These regions also contribute to the market, particularly in areas where malaria is prevalent[1].

Competitive Landscape

The market for quinidine gluconate is competitive, with several pharmaceutical companies involved in its production and distribution. Key players must navigate the challenges of regulatory compliance, patent expirations, and the introduction of new therapies.

Economic Impact

The economic impact of quinidine gluconate is significant, particularly in the context of its use in chronic conditions. For example, the use of dextromethorphan/quinidine (Nuedexta) for pseudobulbar affect (PBA) has shown substantial economic benefits by reducing the frequency of episodes and improving patient quality of life[3].

Pharmacokinetics and Metabolism

Understanding the pharmacokinetics and metabolism of quinidine gluconate is crucial for its effective use. The drug has an absolute bioavailability of 70 to 80% and peak serum levels generally appear 3 to 5 hours after dosing. Food increases the rate and extent of absorption, while grapefruit juice may decrease it[2][4].

Drug Interactions

Quinidine gluconate interacts with several other drugs, which can affect its efficacy and safety. For instance, it inhibits the action of cytochrome P450IID6, converting extensive metabolizers into poor metabolizers. This interaction is critical when prescribing quinidine gluconate with other drugs metabolized by this enzyme[4].

Clinical Indications and Risks

Quinidine gluconate is indicated for restoring normal sinus rhythm in atrial fibrillation/flutter and suppressing ventricular arrhythmias. However, its use comes with significant risks, including proarrhythmic effects and increased mortality. Patients must be informed of these risks and benefits before starting therapy[2][4].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of quinidine gluconate. The drug must comply with stringent regulatory standards, including those set by the FDA. Compliance with USP Dissolution Test 6 is mandatory for extended-release formulations[4].

Patient Compliance and Adherence

Patient compliance and adherence are vital for the effective use of quinidine gluconate. The extended-release formulation helps in maintaining consistent serum levels, which is essential for managing chronic conditions.

Future Outlook

The future outlook for quinidine gluconate is mixed. While it remains a valuable drug in certain therapeutic areas, the emergence of newer antiarrhythmic agents and the risks associated with its use may impact its market share. However, its unique properties and applications ensure it will continue to have a place in the pharmaceutical market.

Key Takeaways

• Market Growth: The quinine market, including quinidine gluconate, is projected to grow at a CAGR of 5.81% by 2032.
• Applications: Quinidine gluconate is used in malaria treatment, antiarrhythmic therapy, and other conditions.
• Distribution: It is distributed through pharmacies, hospitals, online retailers, and wholesalers.
• Regional Markets: Significant markets include North America, Europe, Asia-Pacific, and regions where malaria is prevalent.
• Economic Impact: The drug has substantial economic benefits, particularly in chronic condition management.
• Pharmacokinetics and Interactions: Understanding its pharmacokinetics and potential drug interactions is crucial for safe and effective use.
• Regulatory Compliance: The drug must comply with stringent regulatory standards.

FAQs

What are the primary applications of quinidine gluconate?

Quinidine gluconate is primarily used for malaria treatment, restoring normal sinus rhythm in atrial fibrillation/flutter, and suppressing ventricular arrhythmias.

What are the potential risks associated with quinidine gluconate?

The drug is associated with proarrhythmic effects and an increased risk of mortality. Patients must be informed of these risks before starting therapy.

How does food affect the absorption of quinidine gluconate?

Food increases the rate and extent of absorption of quinidine gluconate by 27% and 17%, respectively.

What are the common distribution channels for quinidine gluconate?

The drug is distributed through pharmacies, hospitals, online retailers, and wholesalers.

What is the projected market size for the quinine market by 2032?

The quinine market, including quinidine gluconate, is projected to reach USD 3.21 billion by 2032.

Sources

1. Market Research Future, Quinine Market Size, Growth Analysis, Trends, Report 2032.
2. FDA, QUINIDINE GLUCONATE.
3. Pharmacy Benefits Management Services, Dextromethorphan Hydrobromide and Quinidine Sulfate (Nuedexta) Drug Monograph.
4. DailyMed, QUINIDINE GLUCONATE- quinidine gluconate tablet, extended release.