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. Ten 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
Patent Applications:	1
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	5,053,432*PED
Glaxosmithkline	MALARONE PEDIATRIC	atovaquone; proguanil hydrochloride	TABLET;ORAL	021078-002	Jul 14, 2000	6,291,488*PED
Glaxosmithkline	MALARONE PEDIATRIC	atovaquone; proguanil hydrochloride	TABLET;ORAL	021078-002	Jul 14, 2000	6,166,046*PED

International Patents for MALARONE PEDIATRIC

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

Country	Patent Number	Title	Estimated Expiration
Israel	71545	3-HYDROXY-1,4-NAPHTHOQUINONE DERIVATIVES,THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM
Romania	119280	ASOCIERE FARMACEUTICĂ, COMPOZIŢIE FARMACEUTICĂ ŞI UTILIZAREA ASOCIERII FARMACEUTICE PENTRU TRATAMENTUL ŞI/SAU PROFILAXIA UNEI INFECŢII CAUZATE DE PROTOZOARE PARAZITE SAU A UNEI INFECŢII CAUZATE DE PNEUMOCYSTIS CARINII (PHARMACEUTICAL ASSOCIATION, PHARMACEUTICAL COMPOSITION AND THE USE OF PHARMACEUTICAL ASSOCIATION FOR THE TREATMENT AND CAUSED BY PARASITIC PROTOZOA OR PROPHILAXIS OF AN INFECTION INFECTIONS OR AN INFECTION CAUSED BY PNEUMOCYSTIS CARINII)
New Zealand	257901	SYNERGISTIC ANTIMALARIAL MIXTURE OF ATOVAGUONE AND PROGUANIL; MEDICAMENTS

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

MALARONE PEDIATRIC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for MALARONE Pediatric

Introduction to MALARONE Pediatric

MALARONE Pediatric, a formulation of atovaquone and proguanil, is a crucial antimalarial medication designed specifically for children. This drug is essential in preventing and treating malaria, a significant health threat in many parts of the world.

Market Size and Growth

The global Atovaquone and Proguanil market, which includes MALARONE Pediatric, is projected to experience substantial growth. As of 2024, the global market size for Atovaquone and Proguanil is estimated to be USD 185.6 million. This market is expected to expand at a compound annual growth rate (CAGR) of 11.50% from 2024 to 2031, reaching USD 397.65 million by 2031[1].

Segment Analysis: Pediatric Formulation

The pediatric formulation of Atovaquone and Proguanil is a key driver of market growth. This segment is fueling market increase by addressing the specific needs of children prone to malaria. The pediatric formulation offers a safe and effective dosage tailored to pediatric populations, improving compliance and efficacy in preventing and treating malaria. Increased awareness of malaria risks among parents and healthcare providers further supports the growing demand for pediatric Atovaquone and Proguanil[1].

Regional Market Dynamics

North America

North America dominates the Atovaquone and Proguanil market, driven by increased travel to malaria-endemic areas and a rising focus on malaria prevention. The region's strong healthcare infrastructure and high disposable incomes contribute to the demand for effective antimalarial medications like MALARONE Pediatric[1].

Europe

Europe is the fastest-growing region in the Atovaquone and Proguanil market. Growing global travel to malaria-prone regions and a heightened focus on malaria prevention measures are key factors. Europe's strong healthcare systems and emphasis on travel medicine also contribute to the demand for reliable antimalarial medications[1].

Asia-Pacific and Other Regions

The Asia-Pacific region is anticipated to show significant growth due to an escalating pediatric population, improved healthcare access, and increasing infectious diseases among children. Other regions, such as Latin America and the Middle East & Africa, also present opportunities for growth, although they currently have smaller market shares[3].

Distribution Channels

Hospital pharmacies play a crucial role in the distribution of pediatric drugs, including MALARONE Pediatric. They capture a significant market share due to their ability to accurately manage and dispense specialized pediatric formulations, ensuring safety and efficacy. The collaboration between hospitals and pharmaceutical industries further bolsters the impact of hospital pharmacies in the pediatric drug market[3].

Technological Advancements and Regulatory Approvals

Technological advancements have led to the development of more advanced diagnostic tools and treatments, increasing the effectiveness of antimalarial drugs like MALARONE Pediatric. Regulatory approvals for new formulations and child-friendly medications also drive market growth by improving compliance and outcomes[4].

Challenges and Threats

Despite the positive growth trajectory, the market for MALARONE Pediatric faces several challenges. These include supply chain disruptions, logistical difficulties, and the diversion of healthcare resources towards other health crises like COVID-19. Additionally, market failures such as limited availability, low quality, and high costs of access in some regions can impact the market's overall growth[1][5].

Financial Trajectory

The financial outlook for MALARONE Pediatric is promising. The increasing demand for effective antimalarial solutions, coupled with the growing awareness of malaria risks, is expected to drive revenue. Here are some key financial metrics:

• Market Size: The global Atovaquone and Proguanil market is expected to grow from USD 185.6 million in 2024 to USD 397.65 million by 2031[1].
• CAGR: The market is projected to grow at a CAGR of 11.50% from 2024 to 2031[1].
• Revenue Drivers: Increased travel to malaria-endemic areas, strong healthcare infrastructure, and high disposable incomes in key regions are significant revenue drivers[1].

Key Takeaways

• The global Atovaquone and Proguanil market, including MALARONE Pediatric, is expected to grow significantly due to increasing demand for antimalarial solutions.
• The pediatric formulation is a key growth driver, addressing the specific needs of children prone to malaria.
• North America and Europe are major markets, with the Asia-Pacific region showing promising growth potential.
• Hospital pharmacies are critical distribution channels for pediatric drugs.
• Technological advancements and regulatory approvals are driving factors for market growth.

FAQs

1. What is the current market size for Atovaquone and Proguanil, including MALARONE Pediatric?

The global Atovaquone and Proguanil market size is estimated to be USD 185.6 million in 2024[1].

2. What is the projected growth rate for the Atovaquone and Proguanil market?

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

3. Which regions are driving the growth of the MALARONE Pediatric market?

North America and Europe are currently the dominant regions, with the Asia-Pacific region showing significant growth potential[1][3].

4. What are the key distribution channels for MALARONE Pediatric?

Hospital pharmacies are the primary distribution channels due to their ability to manage and dispense specialized pediatric formulations accurately[3].

5. What challenges does the MALARONE Pediatric market face?

The market faces challenges such as supply chain disruptions, logistical difficulties, and market failures including limited availability and high costs of access in some regions[1][5].

Cited Sources

1. Cognitive Market Research, "Atovaquone and Proguanil Market Report 2024 (Global Edition)".
2. GSK Pro, "MALARONE Tablets & Pediatric Tablets".
3. Market.US, "Pediatric Drugs Market Growth Analysis | CAGR 12.7%".
4. Custom Market Insights, "Global Antimalarial Drugs Market Size, Trends, Share 2030".
5. Wiley Online Library, "Market for Artemether‐Lumefantrine to treat childhood malaria in a district of southern Mozambique".