ATOVAQUONE; PROGUANIL HYDROCHLORIDE - Generic Drug Details

What are the generic sources for atovaquone; proguanil hydrochloride and what is the scope of patent protection?

Atovaquone; proguanil hydrochloride is the generic ingredient in three branded drugs marketed by Glenmark Pharms Ltd, Mylan, and Glaxosmithkline, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

Ten suppliers are listed for this compound.

Summary for ATOVAQUONE; PROGUANIL HYDROCHLORIDE

US Patents:	0
Tradenames:	3
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	10
Clinical Trials:	25
DailyMed Link:	ATOVAQUONE; PROGUANIL HYDROCHLORIDE at DailyMed

Recent Clinical Trials for ATOVAQUONE; PROGUANIL HYDROCHLORIDE

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

Sponsor	Phase
Australian Defence Force Malaria and Infectious Disease Institute (ADF MIDI)	Phase 4
Naval Medical Research Unit TWO (NAMRU-2)	Phase 4
Naval Medical Research Center	Phase 4

See all ATOVAQUONE; PROGUANIL HYDROCHLORIDE clinical trials

Pharmacology for ATOVAQUONE; PROGUANIL HYDROCHLORIDE

Drug Class	Antimalarial Antiprotozoal
Mechanism of Action	Dihydrofolate Reductase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ATOVAQUONE; PROGUANIL HYDROCHLORIDE

P01AX	Other agents against amoebiasis and other protozoal diseases
P01A	AGENTS AGAINST AMOEBIASIS AND OTHER PROTOZOAL DISEASES
P01	ANTIPROTOZOALS
P	Antiparasitic products, insecticides and repellents

P01BB	Biguanides
P01B	ANTIMALARIALS
P01	ANTIPROTOZOALS
P	Antiparasitic products, insecticides and repellents

Paragraph IV (Patent) Challenges for ATOVAQUONE; PROGUANIL HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MALARONE PEDIATRIC	Tablets	atovaquone; proguanil hydrochloride	62.5 mg/25 mg	021078	1	2010-09-14
MALARONE PEDIATRIC	Tablets	atovaquone; proguanil hydrochloride	250 mg/100 mg	021078	1	2009-04-03

US Patents and Regulatory Information for ATOVAQUONE; PROGUANIL HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	atovaquone; proguanil hydrochloride	TABLET;ORAL	202362-002	May 27, 2014	AB	RX	No	No
Glaxosmithkline	MALARONE	atovaquone; proguanil hydrochloride	TABLET;ORAL	021078-001	Jul 14, 2000	AB	RX	Yes	Yes
Glenmark Pharms Ltd	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	atovaquone; proguanil hydrochloride	TABLET;ORAL	091211-002	Apr 6, 2015	AB	RX	No	No

Expired US Patents for ATOVAQUONE; PROGUANIL HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	MALARONE PEDIATRIC	atovaquone; proguanil hydrochloride	TABLET;ORAL	021078-002	Jul 14, 2000
Glaxosmithkline	MALARONE	atovaquone; proguanil hydrochloride	TABLET;ORAL	021078-001	Jul 14, 2000
Glaxosmithkline	MALARONE PEDIATRIC	atovaquone; proguanil hydrochloride	TABLET;ORAL	021078-002	Jul 14, 2000

ATOVAQUONE; PROGUANIL HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Atovaquone and Proguanil Hydrochloride

Introduction

Atovaquone and Proguanil, commonly known by the brand name Malarone, are antimalarial drugs that have gained significant traction in the global pharmaceutical market. This article delves into the market dynamics, financial trajectory, and key factors influencing the growth of this medication.

Global Market Size and Revenue

As of 2024, the global Atovaquone and Proguanil market size was estimated to be USD 185.6 million. This figure is expected to grow substantially, reaching USD 397.65 million by 2031, with a compound annual growth rate (CAGR) of 11.50% from 2024 to 2031[1].

Regional Market Breakdown

The market is segmented across several regions, each with its own growth trajectory:

North America

North America dominates the market, holding more than 40% of the global revenue with a market size of USD 74.24 million in 2024. This region is expected to grow at a CAGR of 9.7% from 2024 to 2031. The strong healthcare infrastructure and high disposable incomes in this region contribute significantly to the demand for Atovaquone and Proguanil[1].

Europe

Europe is the fastest-growing region, driven by increasing global travel to malaria-endemic areas and a heightened focus on malaria prevention. The market size in Europe was USD 55.68 million in 2024, with a projected CAGR of 10.0% from 2024 to 2031[1].

Asia Pacific

The Asia Pacific region holds around 23% of the global revenue, with a market size of USD 42.6 million in 2024. This region is expected to grow at a CAGR of 13.5% from 2024 to 2031, driven by the rising incidence of malaria and increased travel to endemic areas[1].

Latin America and Middle East & Africa

Latin America accounts for more than 5% of the global revenue, with a market size of USD 9.28 million in 2024, growing at a CAGR of 10.9%. The Middle East and Africa hold around 2% of the global revenue, with a market size of USD 3.71 million in 2024, and are expected to grow at a CAGR of 11.2% from 2024 to 2031[1].

Efficacy and Safety

Atovaquone and Proguanil are highly efficacious as prophylactic agents against malaria, with a prophylaxis efficacy of 95.8% (95% CI = 91.5–97.9)[2]. This medication is also well tolerated, with fewer treatment-related adverse events compared to other antimalarial agents. Studies have shown that Atovaquone and Proguanil have a superior safety profile, leading to better compliance and fewer discontinuations due to adverse effects[2].

Market Drivers

Several factors are driving the growth of the Atovaquone and Proguanil market:

Increasing Travel to Malaria-Endemic Areas

The rise in global travel to regions where malaria is prevalent has significantly increased the demand for effective antimalarial prophylaxis. This trend is particularly noticeable in North America and Europe, where travelers often seek reliable medications to protect against malaria[1].

Strong Healthcare Infrastructure

Regions with robust healthcare systems, such as North America and Europe, contribute to the high demand for Atovaquone and Proguanil due to their ability to afford and access these medications[1].

Rising Malaria Burden

The ongoing burden of malaria, especially in tropical and subtropical regions, continues to drive the need for effective antimalarial drugs. Atovaquone and Proguanil's high efficacy and safety profile make them a preferred choice in these areas[1].

Key Players

The market for Atovaquone and Proguanil is dominated by several key players:

GlaxoSmithKline (GSK)

GSK is one of the primary manufacturers of Atovaquone and Proguanil, marketed under the brand name Malarone.

Glenmark Pharmaceuticals

Glenmark is another significant player, offering generic versions of Atovaquone and Proguanil.

Mylan Pharmaceuticals

Mylan Pharmaceuticals also produces and distributes Atovaquone and Proguanil, contributing to the market's competitive landscape.

Hetero

Hetero is another major player in the market, providing both branded and generic versions of the medication[4].

Financial Projections

The financial trajectory of Atovaquone and Proguanil is promising, with significant growth anticipated over the next several years. Here are some key financial projections:

• Global Market Size by 2031: Expected to reach USD 397.65 million, growing at a CAGR of 11.50% from 2024 to 2031[1].
• Regional Growth: North America, Europe, and Asia Pacific are expected to see substantial growth, driven by increasing demand and favorable market conditions[1].

Applications

Atovaquone and Proguanil are used in both adult and pediatric populations for the prevention and treatment of malaria. The medication's efficacy and safety profile make it suitable for a wide range of patients, further expanding its market reach[4].

Challenges and Opportunities

While the market for Atovaquone and Proguanil is growing, there are challenges and opportunities to consider:

Challenges

• Resistance Development: The potential development of resistance to Atovaquone and Proguanil could impact market growth.
• Competition: The presence of other antimalarial drugs and generic alternatives could pose competition.

Opportunities

• Expanding Travel Markets: Increasing global travel to malaria-endemic areas presents a significant opportunity for growth.
• Improving Healthcare Access: Efforts to improve healthcare access in developing regions could expand the market further[1].

Key Takeaways

• The global Atovaquone and Proguanil market is expected to grow significantly, reaching USD 397.65 million by 2031.
• North America and Europe are the dominant regions, driven by strong healthcare infrastructure and increasing travel to malaria-endemic areas.
• The medication's high efficacy and safety profile make it a preferred choice for malaria prophylaxis.
• Key players such as GSK, Glenmark, Mylan Pharmaceuticals, and Hetero drive the market's competitive landscape.

FAQs

What is the current global market size for Atovaquone and Proguanil?

The global Atovaquone and Proguanil market size was estimated at USD 185.6 million in 2024[1].

Which region dominates the Atovaquone and Proguanil market?

North America dominates the market, holding more than 40% of the global revenue[1].

What is the projected CAGR for the Atovaquone and Proguanil market from 2024 to 2031?

The market is expected to grow at a CAGR of 11.50% from 2024 to 2031[1].

Who are the key players in the Atovaquone and Proguanil market?

Key players include GlaxoSmithKline (GSK), Glenmark Pharmaceuticals, Mylan Pharmaceuticals, and Hetero[4].

What are the primary applications of Atovaquone and Proguanil?

Atovaquone and Proguanil are used for the prevention and treatment of malaria in both adult and pediatric populations[4].

Sources

1. Cognitive Market Research - Atovaquone and Proguanil Market Report 2024 (Global Edition)[1].
2. Oxford Academic - Systematic review and meta-analysis of the effectiveness and safety of atovaquone–proguanil as a chemoprophylactic agent against malaria[2].
3. Pennsylvania State University - Thesis on LIPT1 and LIPT2 enzymes (not directly relevant to Atovaquone and Proguanil market dynamics)[3].
4. Valuates Reports - Atovaquone and Proguanil - Market Size[4].
5. Oxford Academic - Atovaquone–Proguanil (Malarone): an Effective Treatment for Uncomplicated Plasmodium falciparum Malaria[5].