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.

Eight suppliers are listed for this compound.

Summary for atovaquone; proguanil hydrochloride

US Patents:	0
Tradenames:	3
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	8
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
Naval Medical Research Unit TWO (NAMRU-2)	Phase 4
Naval Medical Research Center	Phase 4
Naval Environmental Preventive Medicine Unit TWO (NEPMU-2)	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
Glenmark Pharms Ltd	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	atovaquone; proguanil hydrochloride	TABLET;ORAL	091211-002	Apr 6, 2015	AB	RX	No	No
Glaxosmithkline	MALARONE	atovaquone; proguanil hydrochloride	TABLET;ORAL	021078-001	Jul 14, 2000	AB	RX	Yes	Yes
Mylan	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	atovaquone; proguanil hydrochloride	TABLET;ORAL	202362-001	May 27, 2014	AB	RX	No	No
Glaxosmithkline	MALARONE PEDIATRIC	atovaquone; proguanil hydrochloride	TABLET;ORAL	021078-002	Jul 14, 2000	AB	RX	Yes	No
Glenmark Pharms Ltd	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	atovaquone; proguanil hydrochloride	TABLET;ORAL	091211-001	Jan 12, 2011	AB	RX	No	No
Mylan	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	atovaquone; proguanil hydrochloride	TABLET;ORAL	202362-002	May 27, 2014	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
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

Market Dynamics and Financial Trajectory for Atovaquone-Proguanil Hydrochloride

Last updated: July 27, 2025

Introduction

Atovaquone and proguanil hydrochloride combination, marketed notably as Malarone, has established itself as a leading prophylactic and therapeutic agent against malaria. Its unique pharmacological profile, regulatory landscape, and market positioning influence its financial trajectory within the broader anti-infective drug sector. This report delineates the market dynamics, competitive landscape, regulatory factors, and financial outlook for this pharmaceutical duo, enabling stakeholders to align investment and strategic decisions accordingly.

Pharmacological Profile and Therapeutic Indications

Atovaquone, a ubiquinone analog, inhibits mitochondrial electron transport, disrupting parasite energy production. Proguanil hydrochloride acts as a dihydrofolate reductase inhibitor, impairing nucleic acid synthesis. The combination offers a synergistic effect, enhancing efficacy and reducing resistance development.

Medical applications primarily focus on:

• Malaria prophylaxis: Especially for travelers visiting endemic regions.
• Treatment of uncomplicated Plasmodium falciparum malaria: Particularly in cases resistant to other therapies.

The drug’s favorable safety profile, once-daily dosing, and minimal side effects sustain its demand among travelers and endemic populations.

Market Dynamics

Global Market Size and Growth Drivers

The global anti-malarial market is projected to reach USD 3.5 billion by 2027, with an annual compound growth rate (CAGR) of approximately 3.5% [1]. Atovaquone-proguanil compounds constitute a significant share due to their high efficacy and safety profile.

Key growth drivers include:

• Rising international travel: Increased tourism and business travel to malaria-endemic zones bolster demand.
• Emerging resistance: Resistance to traditional therapies like chloroquine propels the adoption of atovaquone-proguanil.
• Malaria eradication efforts: Global initiatives by WHO and NGOs promote prophylactic use, expanding market reach.

Geographical Market Distribution

• North America: Major market driven by high traveler volume; FDA approvals catalyze sales.
• Europe: Stringent regulatory environment and high traveler awareness contribute to steady demand.
• Africa and Asia-Pacific: Growing endemic populations and public health campaigns elevate local usage, although affordability remains a challenge.

Competitive Landscape

The primary competitor to atovaquone-proguanil is doxycycline and mefloquine, each with distinct side-effect profiles. Recently, artemisinin-based combination therapies (ACTs) threaten some market segments, especially in treatment rather than prophylaxis.

Manufacturers include GSK (original developer), generic pharmaceutical companies, and regional players. Patent expirations and the availability of generics influence pricing strategies and market penetration.

Regulatory Environment

Regulatory bodies like the FDA and EMA have approved atovaquone-proguanil for prophylaxis and treatment. Intellectual property rights, especially patents held by GlaxoSmithKline, impact market exclusivity and pricing. Patent cliffs impending in the next 5-7 years could accelerate generic entry, intensifying price competition.

Financial Trajectory

Revenue Trends and Forecasts

GSK’s sales data reveal consistent growth in atovaquone-proguanil revenues, with global sales reaching approximately USD 350 million in 2022 [2]. The expected CAGR for the next five years is approximately 4%, driven by increased travel and malaria control programs.

Pricing and Market Penetration

Pricing varies regionally. Developed markets typically see premium pricing, while emerging markets benefit from lower prices due to generic availability. Revenue per dosage is projected to decline gradually as generics enter the market, but volume growth may compensate for margin erosion.

R&D and Pipeline Developments

Although the current formulation remains dominant, investment in combination formulations, extended-release versions, and new delivery mechanisms may create future revenue streams. Additionally, research into alternative indications or resistant strains may extend the drug’s market relevance.

Impact of Patent Expiry and Generics

Patent expiry around 2025-2027 in key markets is anticipated to lead to increased generic competition, pressuring prices and margins. Market players investing early in biosimilars or alternative delivery systems could capitalize on this transition.

Strategic Factors Influencing Financial Trajectory

• Global health initiatives: Funding from organizations like WHO and CDC sustain demand.
• Pricing strategies: Tiered pricing and patent litigations influence revenue.
• Market entry of competitors and generics: May dilute market share but also offer opportunities for volume-based growth.

Market Challenges and Risks

• Resistance development: Emerging parasite resistance could reduce efficacy, necessitating product reformulation.
• Regulatory hurdles: Stringent approval processes and patent litigations could delay market expansion.
• Pricing pressures: Transition to generics could erode profit margins.
• Competing Therapies: New antimalarial compounds or vaccines might diminish the drug’s relevance.

Conclusion

The atovaquone-proguanil market exhibits stable growth with moderate acceleration driven by global health initiatives, travel patterns, and resistance challenges. While patent expiries threaten to introduce generic competition, strategic investments in pipeline development and regional market expansion can sustain financial health. Stakeholders must monitor resistance trends, regulatory landscapes, and geopolitical factors to optimize their investment and marketing strategies within this niche but vital pharmacological sector.

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Key Takeaways

• The global atovaquone-proguanil market is projected to grow modestly at a CAGR of approximately 4% over the next five years, driven by increased travel and malaria control efforts.
• Patent expirations forecasted in 2025-2027 will introduce generics, intensifying price competition and compressing margins.
• Regional disparities, including high demand in North America and Europe, alongside growth opportunities in endemic regions, shape market strategies.
• Resistance development warrants ongoing R&D efforts and potential formulation innovations.
• Partnerships with health agencies and adaptive pricing models will be crucial for maintaining revenue streams amidst evolving competitive pressures.

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FAQs

1. How does the patent expiration of atovaquone-proguanil affect its market?
Patent expiration permits generic manufacturers to produce lower-cost versions, increasing competition, reducing prices, and potentially expanding access, but also pressures established brand sales and margins.

2. What are the primary factors influencing the pricing of atovaquone-proguanil in different regions?
Pricing depends on regional regulatory policies, patent status, healthcare infrastructure, disease prevalence, and purchasing power; developed regions typically enjoy higher prices due to brand premiums.

3. How is resistance impacting the future of atovaquone-proguanil?
Growing parasite resistance diminishes drug efficacy, prompting research into new formulations or alternative agents and possibly leading to shifts in prophylactic and therapeutic protocols.

4. What opportunities exist for new formulations or combinations?
Extended-release formulations, alternative delivery routes, and combination therapies including new agents could improve adherence, efficacy, and market share.

5. How do global health initiatives influence sales of atovaquone-proguanil?
Funding and distribution programs by WHO and other entities expand access, especially in endemic and resource-limited settings, stabilizing and potentially increasing demand.

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Sources

[1] Market Research Future. Anti-malarial Drugs Market Analysis 2021.
[2] GlaxoSmithKline Annual Report 2022.