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Last Updated: April 26, 2025

QUINALAN Drug Patent Profile


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When do Quinalan patents expire, and when can generic versions of Quinalan launch?

Quinalan is a drug marketed by Chartwell Molecular and is included in one NDA.

The generic ingredient in QUINALAN is quinidine gluconate. There are twenty-seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the quinidine gluconate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Quinalan

A generic version of QUINALAN was approved as quinidine gluconate by SUN PHARM INDUSTRIES on February 11th, 1987.

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Summary for QUINALAN
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 24
Patent Applications: 1,462
DailyMed Link:QUINALAN at DailyMed
Drug patent expirations by year for QUINALAN

US Patents and Regulatory Information for QUINALAN

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Chartwell Molecular QUINALAN quinidine gluconate TABLET, EXTENDED RELEASE;ORAL 088081-001 Feb 10, 1986 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 1 of 1 entries

Market Dynamics and Financial Trajectory for Quinalan

Introduction

Quinalan, a brand name for the drug quinidine, is a Group I antiarrhythmic medication used primarily to treat abnormal heart rhythms and, in some cases, malaria. To understand the market dynamics and financial trajectory of Quinalan, it is essential to delve into its usage, market segmentation, competitive landscape, and regulatory environment.

Uses and Medical Significance

Quinalan is used to treat various heart rhythm disorders, including atrial flutter and fibrillation, and ventricular arrhythmias. It is also employed in the treatment of malaria, although it should not be confused with quinine, which has different medical uses[2].

Market Segmentation

The market for antiarrhythmic drugs like Quinalan can be segmented based on several factors:

Therapeutic Class

Quinalan falls under the Group I antiarrhythmic category, which is a specific segment within the broader cardiovascular drugs market[2].

Distribution Channels

The drug is distributed through various channels, including hospital pharmacies, online pharmacies, and retail pharmacies. This segmentation helps in understanding the different sales routes and their impact on the market[1].

Geographical Markets

The demand for Quinalan can vary geographically. For instance, North America is a significant market due to high healthcare expenditure and extensive R&D activities. Other regions, such as Asia-Pacific, also show growth potential due to increasing disposable income and healthcare awareness[1].

Competitive Landscape

The antiarrhythmic drug market is competitive, with several other medications available for treating heart rhythm disorders. Here are some key points regarding the competition:

Generic Competition

The generic drug industry plays a crucial role in the antiarrhythmic market. Generic versions of quinidine can enter the market after the patent expiration of the branded version, leading to increased competition and potentially lower prices. Studies have shown that generic drug prices decline as the number of competitors increases, approaching long-run marginal costs when there are eight or more competitors[3].

Alternative Antiarrhythmics

Other antiarrhythmic drugs, including those from different groups (e.g., Group II, III, IV), compete with Quinalan. These alternatives may offer different efficacy and safety profiles, influencing market share and patient preference[2].

Regulatory Environment

Regulatory factors significantly impact the market dynamics of Quinalan:

FDA Approval and Monitoring

The FDA's approval process and ongoing monitoring of drug safety are critical. For instance, the FDA has highlighted the increased mortality risk associated with quinidine use in certain patient groups, which can affect prescribing practices and market demand[2].

Pharmacovigilance

Regulatory bodies like the European Medicines Agency's pharmacovigilance risk assessment committee have advised restricting certain antibiotics and antiarrhythmics due to their long-lasting adverse effects. Such advisories can influence the market by shifting demand towards safer alternatives[1].

Financial Trajectory

To understand the financial trajectory of Quinalan, we need to consider several factors:

Market Size and Growth

While Quinalan is not part of the broader quinolones market, which is projected to grow at a CAGR of 4.5% to reach USD 69.40 billion by 2030, the antiarrhythmic drug market has its own growth dynamics. The increasing incidence of heart rhythm disorders and the aging population contribute to the demand for antiarrhythmic medications[1].

Revenue and Profitability

The revenue generated by Quinalan is influenced by its market share, pricing, and the number of competitors. Generic competition can reduce prices and profitability over time. However, the drug's niche use in treating specific arrhythmias and malaria can maintain a stable revenue stream[3].

Cost and Pricing

The cost of Quinalan, including its production and distribution costs, affects its pricing. Regulatory pressures and competition from generics can lead to price reductions, impacting the drug's profitability. Generic drug prices, for example, fall significantly as the number of competitors increases[3].

Challenges and Opportunities

Safety Concerns

The increased mortality risk associated with quinidine use in certain patient groups is a significant challenge. This has led to a cautious approach by healthcare providers, potentially reducing market demand[2].

Emerging Markets

Growing healthcare awareness and increasing disposable income in regions like Asia-Pacific present opportunities for market expansion. Targeted marketing and distribution strategies can help capitalize on these emerging markets[1].

Key Takeaways

  • Market Segmentation: Quinalan's market is segmented based on therapeutic class, distribution channels, and geographical regions.
  • Competitive Landscape: The drug faces competition from other antiarrhythmic medications and generic versions.
  • Regulatory Environment: FDA approvals, pharmacovigilance, and safety advisories significantly impact market dynamics.
  • Financial Trajectory: The drug's revenue is influenced by market share, pricing, and competition, with opportunities in emerging markets.

FAQs

  1. What is Quinalan used for? Quinalan is used to treat abnormal heart rhythms and, in some cases, malaria[2].

  2. What are the potential side effects of Quinalan? Side effects include abdominal pain, blurred vision, dizziness, fainting, fever, and others. Some side effects are rare but can be severe[2].

  3. How does generic competition affect Quinalan's market? Generic competition can lead to lower prices and reduced profitability as the number of competitors increases[3].

  4. What regulatory factors impact Quinalan's market? FDA approvals, pharmacovigilance, and safety advisories from regulatory bodies like the European Medicines Agency affect the market dynamics of Quinalan[1][2].

  5. What are the growth prospects for Quinalan in emerging markets? Growing healthcare awareness and increasing disposable income in regions like Asia-Pacific present opportunities for market expansion[1].

Sources

  1. Data Bridge Market Research - Global Quinolones Market – Industry Trends and Forecast to 2030
  2. Drugs.com - Quinalan Advanced Patient Information
  3. Federal Trade Commission - Generic Drug Industry Dynamics
  4. Loyola University Chicago - Stock trading during COVID-19 inspires student to find a new career path in business
  5. Brookings Institution - The dynamics of US drug markets

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