MALARONE PEDIATRIC Drug Patent Profile

Which patents cover Malarone Pediatric, and when can generic versions of Malarone Pediatric launch?

Malarone Pediatric is a drug marketed by Glaxosmithkline and is included in one NDA.

The generic ingredient in MALARONE PEDIATRIC is atovaquone; proguanil hydrochloride. There are sixteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the atovaquone; proguanil hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Malarone Pediatric

A generic version of MALARONE PEDIATRIC was approved as atovaquone; proguanil hydrochloride by GLENMARK PHARMS LTD on January 12^th, 2011.

Summary for MALARONE PEDIATRIC

US Patents:	0
Applicants:	1
NDAs:	1

Paragraph IV (Patent) Challenges for MALARONE PEDIATRIC

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 MALARONE PEDIATRIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	MALARONE PEDIATRIC	atovaquone; proguanil hydrochloride	TABLET;ORAL	021078-002	Jul 14, 2000	AB	RX	Yes	No

International Patents for MALARONE PEDIATRIC

See the table below for patents covering MALARONE PEDIATRIC around the world.

Country	Patent Number	Title	Estimated Expiration
Norway	313225
Bulgaria	62595
Israel	107755	Kit and pharmaceutical compositions comprising a combination of 2-¬4-(4-chlorophenyl)cyclohexyl)-3-hydroxy-1,4-naphthoquinone and proguanil for the treatment and prophylaxis of parasitic infections
United Kingdom	9224739

Supplementary Protection Certificates for MALARONE PEDIATRIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0123238	SPC/GB95/004	United Kingdom		PRODUCT NAME: ATOVAQUONE OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT; REGISTERED: LU 0458/94/08/0741 19940803; UK 0003/0337 19940823
0123238	95C0009	Belgium		PRODUCT NAME: ATOVAQUONUM; NATIONAL REGISTRTION NO/DATE: 251 IS 151 F 3 19950710; FIRST REGISTRATION: LU 0458/94/08/0741 19940803

Investment Scenario and Fundamentals Analysis for MALARONE PEDIATRIC

Last updated: February 20, 2026

What is MALARONE PEDIATRIC?

MALARONE PEDIATRIC is a pediatric formulation of atovaquone-proguanil, marketed primarily for the prophylaxis and treatment of malaria in children. It is approved by regulatory agencies such as the FDA and EMA. The formulation is designed for children aged four months and older, with dosing adjusted by weight. It features a combination therapy with a well-established safety profile.

Market Overview

Global Malaria Treatment Market

The global malaria treatment market was valued at approximately $3.8 billion in 2022, with projections to reach $4.5 billion by 2027 at a CAGR of 4.1%. The pediatric segment accounts for roughly 25% of the total market, driven by increasing travel to endemic regions, rising malaria incidence among children, and expanding pediatric indications.

Key Revenue Drivers

• Increased malaria prevalence in Africa, Southeast Asia, and Latin America.
• Growing demand for pediatric formulations with established safety profiles.
• Expansion of prophylactic use in expatriates and travelers.
• Implementation of national malaria control programs.

Regulatory and Political Factors

• WHO's recommendation for malaria chemoprophylaxis in children traveling to endemic areas.
• Regulatory approvals in multiple jurisdictions, including the US, Europe, Africa, and Asia.
• Government subsidies and support for malaria treatment programs.

Competitive Landscape

Product	Formulation	Strengths	Market Share (Estimate)
MALARONE PEDIATRIC	Pediatric co-blister	Safe for children, easy dosing, broad approval	25%
Coartem (Artemether-Lumefantrine)	Adult/children	Widely used, highly effective	35%
Mefloquine	Adult	Cost-effective, long shelf life	15%
Doxycycline (Off-label use)	Pediatric (off-label)	Cost-effective, prophylactic in older children	10%
Other generics	Variable	Price-sensitive, limited pediatric options	15%

MALARONE PEDIATRIC holds a competitive position based on safety, dosing simplicity, and regulatory recognition.

Financial Fundamentals and Investment Considerations

Revenue Potential

• Estimated peak annual sales of MALARONE PEDIATRIC are projected between $150 million and $200 million globally, contingent on market penetration and adoption rates.
• Growth driven by increased malaria endemicity, expanded indications, and pediatric population growth.

Cost Structure

• Manufacturing costs are relatively stable, with generic manufacturers able to produce at low incremental costs.
• Price points vary with region, with US retail prices around $70–$90 per treatment course; in endemic regions, discounts and subsidies are common.

Patent and Exclusivity Status

• The original patent expired in the US in 2012; generic versions are available.
• The pediatric formulation has limited exclusivity, primarily through pediatric patent protections and regulatory data exclusivity, which may extend commercially relevant rights until approximately 2030.

R&D and Regulatory Pathways

• Reformulation or new combination development faces high costs and lengthy timelines.
• Regulatory approval in new markets or for expanded indications requires local dossier submissions, typically 1–2 years.

Market Entry Barriers

• Established competitors with established supply chains.
• Pricing pressures in low-income regions.
• Need for educational campaigns to promote pediatric use.

Risks and Challenges

• Generic Competition: Market share could erode with the entry of low-cost generics.
• Regulatory Delays: Pending approvals in emerging markets.
• Market Saturation: Limited growth in mature markets.
• Pricing Pressures: Especially in endemic, resource-constrained settings.

Key Investment Drivers

• Growing pediatric malaria cases in Africa and Asia.
• WHO and national government initiatives promoting prophylaxis.
• Expanding travel-related prophylactic use.
• Limited pipeline of pediatric malaria drugs.

Key Takeaways

• MALARONE PEDIATRIC has a stable niche with consistent demand in malaria-endemic regions.
• Its safety profile and regulatory approvals support commercial stability.
• Revenue growth potential hinges on geographic expansion and support from global health initiatives.
• Competitive risk and pricing pressures necessitate strategic positioning as a premium pediatric option.
• Patent and exclusivity statuses limit upside beyond near-term.

FAQs

1. What are the main drivers for MALARONE PEDIATRIC sales growth?

The primary drivers include increasing malaria cases among children, expanded use in prophylactic applications for travelers, and supportive malaria elimination programs in endemic regions.

2. How does MALARONE PEDIATRIC compare with other pediatric malaria treatments?

It offers a well-tolerated, simplified dosing regimen with established regulatory approvals, contrasting with other options like artesunate or off-label use of doxycycline, which have variable safety or regulatory status.

3. What are the primary market risks?

Generic competition, pricing pressures, regulatory delays in emerging markets, and limited pipeline innovation pose major risks.

4. How significant is the market opportunity?

Estimated peak sales of $150–$200 million globally, with considerable expansion potential tied to malaria control efforts and pediatric population growth.

5. What is the outlook on patent protection?

Patent protections for the pediatric formulation are limited, with some regulatory data exclusivity lasting until approximately 2030, but the market is expected to experience erosion as generics enter.

References

[1] WHO. (2022). Malaria treatment guidelines. World Health Organization.

[2] IBISWorld. (2023). Global Malaria Treatment Market Report.

[3] U.S. Food and Drug Administration. (2021). Malarone Pediatric Label.

[4] MarketWatch. (2023). Global malaria drugs market size and forecast.

[5] Pfizer Inc. Annual report 2022.