MALARONE PEDIATRIC Drug Patent Profile

Which patents cover Malarone Pediatric, and what generic alternatives are available?

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
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	22
Drug Prices:	Drug price information for MALARONE PEDIATRIC
DailyMed Link:	MALARONE PEDIATRIC at DailyMed

See drug prices for MALARONE PEDIATRIC

Recent Clinical Trials for MALARONE PEDIATRIC

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 MALARONE PEDIATRIC clinical trials

Pharmacology for MALARONE PEDIATRIC

Drug Class	Antimalarial Antiprotozoal
Mechanism of Action	Dihydrofolate Reductase Inhibitors

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

Expired US Patents for MALARONE PEDIATRIC

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 PEDIATRIC	atovaquone; proguanil hydrochloride	TABLET;ORAL	021078-002	Jul 14, 2000
Glaxosmithkline	MALARONE PEDIATRIC	atovaquone; proguanil hydrochloride	TABLET;ORAL	021078-002	Jul 14, 2000

International Patents for MALARONE PEDIATRIC

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

Country	Patent Number	Title	Estimated Expiration
Latvia	5762	Naftohinona atvasinajumi
Canada	2150234
Poland	309222

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

Market Dynamics and Financial Trajectory for Malarone Pediatric

Last updated: August 16, 2025

Introduction

Malarone Pediatric, an antimalarial medication primarily indicated for the treatment and prophylaxis of malaria in children, has carved out a significant niche within the global antimalarial market. Its active components—atovaquone and proguanil hydrochloride—offer a compelling combination with favorable safety and efficacy profiles, especially in pediatric patients. Given the rising malaria burden in endemic regions and evolving market forces, understanding the market dynamics and financial trajectory of Malarone Pediatric is essential for stakeholders across the pharmaceutical, healthcare, and investment sectors.

Market Overview

Globally, malaria remains a major public health threat, with the World Health Organization (WHO) estimating over 200 million cases annually, predominantly in sub-Saharan Africa, Southeast Asia, and parts of Latin America [1]. The pediatric population bears a disproportionate burden, accounting for approximately 70% of malaria cases and deaths in children under five [2].

The global antimalarial drug market was valued at approximately USD 4.2 billion in 2022 and is projected to grow at a CAGR of 3–4% through 2030 [3]. Malarone Pediatric, as a branded and patented formulation, commands a substantial share within this segment, driven by its proven efficacy and favorable safety profile, which favor pediatric compliance.

Market Drivers

1. Rising Malaria Incidence in Pediatric Populations

Endemic regions report increasing pediatric malaria cases due to factors like drug resistance, insecticide resistance, and climatic influences on mosquito habitats. The WHO emphasizes the need for effective pediatric-specific prophylaxis and treatment options, which sustains demand for drugs like Malarone Pediatric [1].

2. Favorable Safety and Tolerability Profile

Compared with other antimalarials such as chloroquine or quinine, Malarone Pediatric has fewer adverse events, making it suitable for children. Its once-daily dosing regimen enhances adherence, critical for prophylactic use in pediatric populations.

3. Expanding Malarone Prescription Use Cases

Beyond treatment, evolving guidelines support the use of Malarone Pediatric for prophylaxis in travelers and in endemic regions, broadening its functional utility.

4. Commercial Presence in Key Markets

Major pharmaceutical firms market Malarone Pediatric globally, leveraging established distribution networks. Its patent exclusivity—though nearing expiration in some jurisdictions—underpins a period of market exclusivity, safeguarding revenue streams.

Market Challenges

1. Patent Expiry and Generic Competition

The imminent or recent expiration of Malarone Pediatric's patent rights could introduce generic competitors, significantly impacting its market share and pricing power.

2. Price Sensitivity in Endemic Regions

In low-resource settings, price sensitivity hampers the widespread adoption of branded formulations. This is compounded by procurement through government tenders that favor generic alternatives.

3. Resistance and Evolving Treatment Guidelines

Emerging resistance patterns threaten the long-term efficacy of atovaquone/proguanil-based therapies. Changes in WHO and national treatment protocols could alter prescribing patterns, potentially reducing demand.

4. Competition from Other Formulations

Fixed-dose combination therapies, alternative prophylactic agents, and newer antimalarial compounds such as tafenoquine or arterolane-based drugs are diversifying the anti-malarial landscape.

Financial Trajectory Analysis

Revenue Trends & Market Share

Historically, Malarone Pediatric has demonstrated consistent revenue growth in developed markets, particularly North America and Europe, where malaria prophylaxis in travelers and seasonal travelers is prevalent. In 2022, it accounted for approximately 60% of the pediatric antimalarial market share in these regions [3].

Impact of Patent Expiration and Generics

As patents expire in key jurisdictions—e.g., the U.S. and EU—generics are anticipated to enter the market within the next 2–3 years. This could lead to a decline in unit prices by up to 50%, as observed with similar drugs (e.g., Coartem). The projected revenue trajectory indicates a peak just before patent expiry, followed by a gradual decline unless offset by increased volume sales or new indications.

Emerging Markets and Outreach

In endemic regions, especially in Africa and Southeast Asia, the revenue contribution from Malarone Pediatric remains moderate, constrained by affordability issues. However, global initiatives led by WHO and non-governmental organizations to subsidize pediatric prophylaxis could stimulate demand, enhancing revenue prospects.

Investment and R&D Outlook

Manufacturers are exploring reformulations, including dispersible and pediatric-friendly formats, expected to expand market penetration. Investments are also directed toward developing resistanceresistant formulations, which could reestablish market dominance and justify premium pricing.

Future Market Opportunities

1. New Indications & Expanded Use

Research into Malarone Pediatric’s role in asymptomatic malaria carriers and its integration into combination therapies presents growth avenues. Additionally, its use in chemoprophylaxis for travelers to emerging malaria zones could expand.

2. Strategic Collaborations

Partnerships geared toward generic manufacturing in low-resource settings are anticipated to facilitate broader access, potentially offsetting revenue losses from patent cliff phases.

3. Digital and Supply Chain Innovation

Adoption of digital adherence tools, improved supply chain management, and targeted awareness campaigns can improve treatment uptake, translating to sustained revenues.

Regulatory & Policy Impacts

Regulatory agencies’ evolving approval pathways and drug-monitoring frameworks significantly influence Malarone Pediatric’s financial trajectory. For instance, WHO prequalification and national procurement policies in Africa and Asia influence market accessibility and volume growth.

Key Takeaways

• Market Growth Drivers: Rising pediatric malaria cases, safety profile, and expanded prophylactic applications bolster market demand.
• Challenges: Patent expiration, generic competition, resistance patterns, and price sensitivity threaten revenues.
• Revenue Outlook: Peak revenues are projected pre-patent expiry, with an eventual decline unless complemented by new indications or reformulations.
• Strategic Opportunities: Innovation in formulations, exploring new indications, and strategic partnerships can sustain or augment market position.
• Market Expansion: Focus on endemic regions through subsidization and tailored strategies remains crucial for long-term growth.

Conclusion

Malarone Pediatric remains a cornerstone in pediatric malaria management, with a resilient market presence driven by clinical efficacy and safety. However, competitive pressures, patent dynamics, and resistance issues necessitate innovative strategies to sustain its financial trajectory. Stakeholders must balance immediate revenue maximization with long-term diversification to navigate market challenges successfully.

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FAQs

Q1: How will patent expiration affect Malarone Pediatric's market share?
A: Patent expiration is likely to introduce generic competitors, exerting downward pressure on prices and potentially reducing market share and revenues—unless strategic measures such as formulation upgrades or new indications are implemented.

Q2: What strategies can manufacturers adopt to extend Malarone Pediatric’s market viability?
A: Developing pediatric-friendly formulations, expanding indications (e.g., prophylaxis, treatment of resistant strains), forming strategic partnerships, and increasing access in endemic regions are key approaches.

Q3: How does resistance impact Malarone Pediatric’s sales prospects?
A: Rising resistance to atovaquone/proguanil threatens efficacy, potentially leading to reduced prescription rates unless alternative formulations or combinations are developed to counter resistance.

Q4: Are there significant opportunities in emerging markets for Malarone Pediatric?
A: Yes, especially through partnerships that subsidize costs and improve distribution. However, price sensitivity and competition from generics remain obstacles.

Q5: What role do regulatory agencies play in Malarone Pediatric's future market trajectory?
A: Regulatory approvals facilitate market access and acceptance. Stringent standards and evolving policies can either restrict or open markets, impacting sales volume and strategic planning.

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References

[1] WHO. World Malaria Report 2022. World Health Organization.
[2] World Bank. Malaria Burden and Pediatric Impact. 2021.
[3] Grand View Research. Global Antimalarial Market Analysis. 2022.