QUININE SULFATE - Generic Drug Details

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

Quinine sulfate is the generic ingredient in two branded drugs marketed by Sun Pharm Industries, Amneal Pharms, Aurobindo Pharma Usa, Lupin Ltd, Novast Labs, and Teva Pharms, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for quinine sulfate. Five suppliers are listed for this compound.

Summary for QUININE SULFATE

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	6
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	205
Clinical Trials:	17
Patent Applications:	4,848
Drug Prices:	Drug price trends for QUININE SULFATE
What excipients (inactive ingredients) are in QUININE SULFATE?	QUININE SULFATE excipients list
DailyMed Link:	QUININE SULFATE at DailyMed

See drug prices for QUININE SULFATE

Recent Clinical Trials for QUININE SULFATE

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

Sponsor	Phase
Hiroshi Mitsumoto	Phase 1/Phase 2
Universitas Padjadjaran	N/A
Prodia Diacro Laboratories P.T.	N/A

See all QUININE SULFATE clinical trials

Pharmacology for QUININE SULFATE

Drug Class

Antimalarial

Medical Subject Heading (MeSH) Categories for QUININE SULFATE

Analgesics, Non-Narcotic

Antimalarials

Muscle Relaxants, Central

Anatomical Therapeutic Chemical (ATC) Classes for QUININE SULFATE

P01BC	Methanolquinolines
P01B	ANTIMALARIALS
P01	ANTIPROTOZOALS
P	Antiparasitic products, insecticides and repellents

US Patents and Regulatory Information for QUININE SULFATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lupin Ltd	QUININE SULFATE	quinine sulfate	CAPSULE;ORAL	203112-001	Apr 24, 2015	AB	RX	No	No
Novast Labs	QUININE SULFATE	quinine sulfate	CAPSULE;ORAL	204372-001	Jul 22, 2015	AB	RX	No	Yes
Sun Pharm Industries	QUALAQUIN	quinine sulfate	CAPSULE;ORAL	021799-001	Aug 12, 2005		DISCN	Yes	No
Aurobindo Pharma Usa	QUININE SULFATE	quinine sulfate	CAPSULE;ORAL	202581-001	Dec 14, 2012		DISCN	No	No
Teva Pharms	QUININE SULFATE	quinine sulfate	CAPSULE;ORAL	091661-001	Sep 28, 2012	AB	RX	No	No

QUININE SULFATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Quinine Sulfate

Introduction to Quinine Sulfate

Quinine sulfate, an alkaloid derived from the bark of the cinchona tree, is a crucial medication primarily used for treating malaria and relieving nocturnal leg cramps. Its therapeutic benefits and natural origin make it a significant player in the pharmaceutical market.

Current Market Size and Growth

The quinine sulfate market has experienced substantial growth in recent years. As of 2023, the market size was valued at $2.23 billion, and it is projected to grow to $2.41 billion in 2024, reflecting a compound annual growth rate (CAGR) of 8.3%[2][4].

Forecasted Growth and Projections

Looking ahead, the market is anticipated to continue its robust growth, reaching $3.33 billion by 2028 at a CAGR of 8.4%. This forecasted growth is driven by several key factors, including:

• Increased Focus on Tropical Diseases: There is a heightened emphasis on treating tropical diseases, particularly malaria, which is a major driver of the quinine sulfate market[1][2][4].
• Rising Healthcare Expenditures: Developing nations are increasing their healthcare spending, which includes investments in anti-malarial treatments[1][2][4].
• Growing Demand for Muscle Relaxant Medications: Quinine sulfate's use in relieving muscle cramps contributes to its growing demand[1][2][4].
• Expanding Population in Malaria-Endemic Areas: The increasing population in regions prone to malaria further drives the demand for quinine sulfate[1][2][4].
• Improvements in Raw Material Supply Chain: Enhancements in the supply chain for raw materials are expected to support the market's growth[1][2][4].

Market Segmentation

The quinine sulfate market is segmented in several ways:

By Type

• 200mg
• 300mg
• Other Types[1][4].

By Product

• Quinine Sulfate Tablets
• Quinine Sulfate Capsules
• Quinine Sulfate Injections
• Quinine Sulfate Powder
• Quinine Sulfate Oral Solutions[1][4].

By Distribution Channel

• Hospitals
• Retail Pharmacies
• Online Pharmacies[1][4].

By Application

• Malaria
• Problematic Leg Cramps
• Lupus
• Rheumatoid Arthritis
• Other Applications[1][4].

By End-User

• Adults
• Pediatrics
• Geriatrics[1][4].

Regional Insights

The Asia-Pacific region was the largest market for quinine sulfate in 2023, followed by other regions such as Western Europe, Eastern Europe, North America, South America, the Middle East, and Africa[1][2][4].

Key Trends Shaping the Market

Several trends are expected to influence the quinine sulfate market in the coming years:

Demand for Generic Anti-Malarial Drugs

There is an increasing demand for generic versions of anti-malarial drugs, which is expected to drive the market forward[2][4].

Investment in Healthcare in Emerging Markets

Rising investment in healthcare within emerging markets is another significant trend. This includes technological integration in pharmaceutical production and a growing regulatory emphasis on drug safety[2][4].

Global Commitment to Malaria Eradication

The global commitment to malaria eradication strategies is also a key driver. For instance, the World Health Organization (WHO) reported approximately 249 million malaria cases globally in 2022, highlighting the ongoing need for effective treatments[2].

Increasing Interest in Natural and Organic Products

The growing interest in natural and organic products is fueling the demand for quinine sulfate. Consumers are increasingly preferring products derived from natural sources, such as cinchona bark, due to their perceived health benefits and environmental sustainability[2][4].

"US sales of certified organic products approached $70 billion in 2023, with dollar sales hitting $69.7 billion, up 3.4 percent from 2022," according to the Organic Trade Association (OTA)[2][4].

Innovative Solutions and Technological Advancements

Leading companies in the quinine sulfate market are focusing on developing innovative solutions to optimize the production process. This includes more efficient synthesis methods for quinine and its derivatives, aimed at reducing time, waste, and costs while enhancing chemical synthesis capabilities. For example, Tohoku University achieved a breakthrough in the enantioselective synthesis of quinine using organ catalysts, which streamlines the production process and minimizes chemical waste[2].

Key Players in the Market

Several major companies are operating in the quinine sulfate market, including:

• Sanofi SA
• Thermo Fisher Scientific Inc.
• Viatris Inc.
• Teva Pharmaceuticals
• Sun Pharmaceutical Industries Ltd.
• Aurobindo Pharma
• Dr. Reddy's Laboratories
• Cipla Limited
• Lupin Limited
• Strides Pharma
• Taj Pharmaceuticals
• Wockhardt Ltd.
• Alchem International Private Limited
• SimSon Pharma Limited
• Hangzhou Dayang Co. Ltd.
• Haihang Industry Co. Ltd.
• Pharmakina SA
• Aecochem Corp
• Buchler GmbH
• Prism Industries Private Limited
• Shreeji Pharma International
• Trademax Pharmaceuticals & Chemicals
• Sihauli Chemicals Private Limited[1][2][4].

Macro Economic Scenario

The quinine sulfate market is influenced by various macroeconomic factors:

Impact of High Inflation

High inflation can affect the production costs and pricing strategies of quinine sulfate manufacturers[4].

Ukraine-Russia War Impact

Global conflicts, such as the Ukraine-Russia war, can disrupt supply chains and affect raw material availability[4].

COVID-19 Impact

The COVID-19 pandemic has highlighted the importance of robust healthcare systems and the need for effective treatments for infectious diseases, including malaria[4].

Key Takeaways

• The quinine sulfate market is projected to grow significantly, reaching $3.33 billion by 2028.
• Key drivers include the increasing prevalence of malaria, rising healthcare expenditures, and growing demand for natural and organic products.
• The market is segmented by type, product, distribution channel, application, and end-user.
• Asia-Pacific is the largest region in the quinine sulfate market.
• Innovative production methods and a global commitment to malaria eradication are shaping the market's future.

Frequently Asked Questions (FAQs)

1. What is the primary use of quinine sulfate? Quinine sulfate is primarily used for treating malaria and relieving nocturnal leg cramps.

2. What is the projected market size of quinine sulfate by 2028? The quinine sulfate market is expected to reach $3.33 billion by 2028 at a CAGR of 8.4%[1][2][4].

3. Which region dominates the quinine sulfate market? The Asia-Pacific region is the largest market for quinine sulfate[1][2][4].

4. What are the key trends driving the quinine sulfate market? Key trends include the demand for generic anti-malarial drugs, investment in healthcare in emerging markets, technological integration in pharmaceutical production, and a growing interest in natural and organic products[2][4].

5. Who are some of the major players in the quinine sulfate market? Major players include Sanofi SA, Thermo Fisher Scientific Inc., Viatris Inc., Teva Pharmaceuticals, and Sun Pharmaceutical Industries Ltd., among others[1][2][4].

Sources Cited

1. The Business Research Company, "Comprehensive Study On The Global Quinine Sulfate Market: Trends And Market Opportunities 2024-2033"[1].
2. GII Research, "Quinine Sulfate Global Market Report 2024"[2].
3. Market Research Intellect, "Quinine Sulphate Market Size And Projection"[3].
4. The Business Research Company, "Quinine Sulfate Global Market Report 2024"[4].