QUINIDINE SULFATE - Generic Drug Details

What are the generic drug sources for quinidine sulfate and what is the scope of patent protection?

Quinidine sulfate is the generic ingredient in four branded drugs marketed by Solvay, Lilly, Wyeth Pharms Inc, Cosette, Barr, Chartwell Molecular, Chartwell Rx, Contract Pharmacal, Cycle, Dava Pharms Inc, Elkins Sinn, Epic Pharma Llc, Everylife, Halsey, Hikma, Impax Labs, Ivax Sub Teva Pharms, King Pharms, Kv Pharm, Lederle, Perrigo, Pharmavite, Purepac Pharm, Sandoz, Scherer Labs, Sun Pharm Industries, Superpharm, Usl Pharma, Valeant Pharm Intl, Vangard, Vintage Pharms, Warner Chilcott, Watson Labs, Whiteworth Town Plsn, Key Pharms, and Schering, and is included in forty-eight NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for quinidine sulfate. Two suppliers are listed for this compound.

Summary for QUINIDINE SULFATE

US Patents:	0
Tradenames:	4
Applicants:	36
NDAs:	48
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	214
Clinical Trials:	21
Patent Applications:	4,947
Drug Prices:	Drug price trends for QUINIDINE SULFATE
What excipients (inactive ingredients) are in QUINIDINE SULFATE?	QUINIDINE SULFATE excipients list
DailyMed Link:	QUINIDINE SULFATE at DailyMed

See drug prices for QUINIDINE SULFATE

Recent Clinical Trials for QUINIDINE SULFATE

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

Sponsor	Phase
ALS Association	Phase 1/Phase 2
University of Florida	Phase 1/Phase 2
Holy Cross Hospital, Florida	Phase 1/Phase 2

See all QUINIDINE SULFATE clinical trials

Pharmacology for QUINIDINE SULFATE

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

Anatomical Therapeutic Chemical (ATC) Classes for QUINIDINE SULFATE

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

US Patents and Regulatory Information for QUINIDINE SULFATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dava Pharms Inc	QUINIDINE SULFATE	quinidine sulfate	TABLET;ORAL	087011-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Cycle	QUINIDINE SULFATE	quinidine sulfate	TABLET;ORAL	085632-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Wyeth Pharms Inc	QUINIDEX	quinidine sulfate	TABLET, EXTENDED RELEASE;ORAL	012796-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Hikma	QUINIDINE SULFATE	quinidine sulfate	TABLET;ORAL	083862-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Cycle	QUINIDINE SULFATE	quinidine sulfate	TABLET;ORAL	083640-001	Approved Prior to Jan 1, 1982		DISCN	No	No

QUINIDINE SULFATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Quinidine Sulfate

Introduction to Quinidine Sulfate

Quinidine sulfate is a crucial therapeutic agent primarily used in the treatment of malaria and various cardiovascular conditions, including arrhythmias. Its effectiveness against different strains of Plasmodium parasites and its administration via both intravenous and oral routes make it a vital component in the healthcare industry.

Market Size and Growth Projections

The quinidine sulfate market is anticipated to experience significant growth in the coming years. Here are some key projections:

• The market size is forecast to increase by USD 272.6 million at a Compound Annual Growth Rate (CAGR) of 4.5% between 2023 and 2028[1].
• Another report suggests that the global quinidine sulfate market is expected to reach USD 500 million by 2030, growing at a CAGR of 7.1% from 2023 to 2030[2].

Driving Factors

Several factors are driving the growth of the quinidine sulfate market:

• Rising Incidence of Malaria: The increasing number of malaria cases globally, particularly in regions like Africa and parts of Asia, is a major driver. According to the World Health Organization (WHO), there were approximately 229 million malaria cases and 405,000 deaths in 2019[1].
• Strong Funding for Malaria Eradication: Significant funding from governments and international organizations, such as the Bill and Melinda Gates Foundation and the World Bank, is boosting the market. These funds support awareness campaigns, medical technology advancements, and healthcare infrastructure[1].
• Emergence of Insecticide-Resistant Vectors: The rise of insecticide-resistant Anopheles mosquitoes has increased the demand for alternative treatments like quinidine sulfate[1].
• Cardiovascular Applications: Quinidine sulfate is also widely used in managing arrhythmias, particularly in the geriatric population and those with cardiovascular genetic disorders. Investments in cardiovascular departments and government awareness programs about heart diseases are additional drivers[2].

Regional Trends

The market is geographically diverse, with different regions contributing significantly:

• Asia-Pacific: This region is expected to contribute substantially to the market growth, with an estimated 44% contribution during the forecast period. Factors such as a surge in the geriatric population, development of therapeutics, and enhanced accessibility of pharmaceutical products are driving growth in this region[1][2].
• North America and Europe: These regions also play a significant role, with countries like the U.S., Canada, Germany, and the U.K. contributing to the market due to advanced healthcare infrastructure and high awareness about cardiovascular and communicable diseases[2].

Challenges and Limitations

Despite the growth potential, the market faces several challenges:

• Regulatory Restrictions: Quinidine sulfate is subject to regulatory restrictions due to its potential pharmacological side effects, such as gastrointestinal issues, tinnitus, and visual disturbances collectively known as cinchonism[1].
• Pharmacological Side Effects: These side effects necessitate ongoing research and development to improve drug delivery technologies and novel formulations, aiming for individualized medicine and better patient outcomes[1].

Market Strategies and Competitive Landscape

Companies in the quinidine sulfate market are adopting various strategies to enhance their market presence:

• Strategic Alliances and Partnerships: Companies are engaging in strategic alliances, partnerships, mergers, and acquisitions to expand their reach and improve product offerings[1].
• Geographical Expansion: Expanding into new regions, especially in Asia-Pacific, is a key strategy. For example, Bennet Pharmaceuticals Ltd. offers quinidine sulfate under the brand name Quinet[1].
• Product/Service Launches: Continuous innovation in drug delivery technologies and the development of novel formulations are critical for mitigating side effects and improving patient compliance[1].

Customer Landscape and Purchase Criteria

The customer landscape is influenced by several factors:

• Adoption Lifecycle: The market adoption lifecycle varies across regions, with different stages of adoption from innovators to laggards. Understanding these stages helps companies develop targeted market growth strategies[1].
• Price Sensitivity: The report highlights key purchase criteria and drivers of price sensitivity, which are essential for companies to evaluate and develop their market growth analysis strategies[1].

Financial Trajectory

The financial trajectory of the quinidine sulfate market is promising:

• Current Market Size: The market was valued at USD 340 million in 2022 and is expected to grow significantly over the forecast period[2].
• Future Projections: The market is projected to reach USD 500 million by 2030, with a CAGR of 7.1% from 2023 to 2030. Another projection estimates the market to grow at a CAGR of 6.30% to reach USD 13.74 billion in 2024 and further grow in subsequent years[2][5].

Illustrative Statistics

• The global quinidine sulfate market grew from USD 12.79 billion in 2023 to USD 13.74 billion in 2024, with a projected CAGR of 6.30%[5].
• Asia-Pacific is expected to grow with a high CAGR during the forecast period, driven by factors such as a surge in the geriatric population and enhanced accessibility of pharmaceutical products[2].

Quotes from Industry Experts

While specific quotes from industry experts are not available in the provided sources, the emphasis on continuous innovation and the need for individualized medicine is a common theme. For instance, the focus on novel formulations and drug delivery technologies to mitigate side effects and improve patient outcomes is a critical area of research and development.

Key Takeaways

• The quinidine sulfate market is driven by the rising incidence of malaria and cardiovascular diseases.
• Strong funding for malaria eradication and the emergence of insecticide-resistant vectors are significant drivers.
• Asia-Pacific is expected to contribute substantially to the market growth.
• Regulatory restrictions and pharmacological side effects pose challenges that are being addressed through research and development.
• Companies are adopting various strategies to enhance their market presence, including strategic alliances and geographical expansion.

Frequently Asked Questions (FAQs)

Q1: What is the current market size of the quinidine sulfate market?

The quinidine sulfate market was valued at USD 340 million in 2022 and is expected to grow significantly over the forecast period[2].

Q2: What are the primary applications of quinidine sulfate?

Quinidine sulfate is primarily used in the treatment of malaria and various cardiovascular conditions, including arrhythmias[1][3].

Q3: Which region is expected to contribute the most to the market growth?

Asia-Pacific is expected to contribute significantly to the market growth, with an estimated 44% contribution during the forecast period[1][2].

Q4: What are the major challenges facing the quinidine sulfate market?

The market faces challenges such as regulatory restrictions and pharmacological side effects, including gastrointestinal issues, tinnitus, and visual disturbances[1].

Q5: How are companies addressing the side effects of quinidine sulfate?

Companies are focusing on research and development to improve drug delivery technologies and novel formulations, aiming for individualized medicine and better patient outcomes[1].

Sources:

1. Technavio: Quinidine Sulfate Market Size, Share | Growth Industry Analysis 2028
2. Univdatos Market Insights: Quinidine Sulfate Market: Current Analysis and Forecast (2023-2030)
3. Allied Market Research: Quinidine Sulfate Market
4. Research and Markets: Global Quinidine Sulfate Market by Route of Administration
5. Research and Markets: Quinidine Sulfate Market Size, Share & Forecast to 2030