MALARONE Drug Patent Profile

When do Malarone patents expire, and when can generic versions of Malarone launch?

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

The generic ingredient in MALARONE is atovaquone; proguanil hydrochloride. There are sixteen drug master file entries for this compound. Nine 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

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

Summary for MALARONE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	22
Patent Applications:	1,374
Drug Prices:	Drug price information for MALARONE
What excipients (inactive ingredients) are in MALARONE?	MALARONE excipients list
DailyMed Link:	MALARONE at DailyMed

See drug prices for MALARONE

Recent Clinical Trials for MALARONE

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

Sponsor	Phase
Naval Environmental Preventive Medicine Unit TWO (NEPMU-2)	Phase 4
The 108 Military Central Hospital	Phase 4
Australian Defence Force Malaria and Infectious Disease Institute (ADF MIDI)	Phase 4

See all MALARONE clinical trials

Pharmacology for MALARONE

Drug Class	Antimalarial Antiprotozoal
Mechanism of Action	Dihydrofolate Reductase Inhibitors

US Patents and Regulatory Information for MALARONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	MALARONE	atovaquone; proguanil hydrochloride	TABLET;ORAL	021078-001	Jul 14, 2000	AB	RX	Yes	Yes
Glaxosmithkline	MALARONE PEDIATRIC	atovaquone; proguanil hydrochloride	TABLET;ORAL	021078-002	Jul 14, 2000	AB	RX	Yes	No

Expired US Patents for MALARONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	MALARONE	atovaquone; proguanil hydrochloride	TABLET;ORAL	021078-001	Jul 14, 2000	5,053,432*PED
Glaxosmithkline	MALARONE	atovaquone; proguanil hydrochloride	TABLET;ORAL	021078-001	Jul 14, 2000	6,291,488*PED
Glaxosmithkline	MALARONE	atovaquone; proguanil hydrochloride	TABLET;ORAL	021078-001	Jul 14, 2000	5,998,449*PED

International Patents for MALARONE

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

Country	Patent Number	Title	Estimated Expiration
Australia	5532194
Germany	3464132
Japan	H08503938

Supplementary Protection Certificates for MALARONE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0123238	95C0009	Belgium		PRODUCT NAME: ATOVAQUONUM; NATIONAL REGISTRTION NO/DATE: 251 IS 151 F 3 19950710; FIRST REGISTRATION: LU 0458/94/08/0741 19940803
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

Market Dynamics and Financial Trajectory for Antimalarial Drugs: A Focus on MALARONE

Introduction

Antimalarial drugs, including MALARONE, are crucial in the global fight against malaria, a disease that continues to pose significant health challenges, particularly in tropical and subtropical regions. This article delves into the market dynamics and financial trajectory of the antimalarial drugs market, with a specific focus on MALARONE.

Global Antimalarial Drugs Market Overview

The global antimalarial drugs market is driven by several key factors:

Rising Prevalence of Malaria

Malaria remains a significant health burden globally, with millions of cases and thousands of deaths reported annually. This persistent demand for effective treatments drives the market growth[1][4].

Increasing Healthcare Spending

Global healthcare spending is on the rise, which includes increased investment in research and development for new and advanced antimalarial drugs. This trend is expected to continue, fueling market growth[4].

Government Initiatives and Awareness

Government policies and social campaigns aimed at malaria awareness and control contribute significantly to the market's expansion. These initiatives often include distribution of antimalarial drugs, which boosts demand[3][4].

Market Segmentation

The antimalarial drugs market is segmented based on several criteria:

Drug Class

The market includes various drug classes such as quinine, chloroquine, proguanil, mefloquine, pyrimethamine, and others. MALARONE, which is a combination of atovaquone and proguanil, falls under this category[3][4].

Distribution Channels

The drugs are distributed through hospital pharmacies, retail pharmacies, e-commerce platforms, and other channels. Hospital pharmacies are a significant segment due to the high demand for antimalarial treatments in healthcare settings[3][4].

MALARONE: A Key Player in the Market

What is MALARONE?

MALARONE is a combination antimalarial drug consisting of atovaquone and proguanil. It is widely used for the prevention and treatment of malaria, particularly in areas where the disease is prevalent.

Market Position

MALARONE is one of the prominent antimalarial drugs in the market, known for its efficacy and relatively lower side effect profile compared to some other treatments. It is marketed by GlaxoSmithKline (GSK), a major pharmaceutical company with a strong presence in the global healthcare market[2].

Financial Performance and Outlook

Global Market Size and Growth

The global antimalarial drugs market was valued at USD 989.7 million in 2023 and is expected to grow at a CAGR of 4.26% from 2024 to 2030. This growth is driven by the increasing demand for effective antimalarial treatments and continuous efforts to develop innovative drugs[1].

Revenue and Sales

GSK, the manufacturer of MALARONE, reported strong financial performance in 2023, with total sales of £30.3 billion, a 5% increase from the previous year. While the specific sales figures for MALARONE are not detailed in the report, the overall performance of GSK's Specialty Medicines segment, which includes antimalarial drugs, indicates a positive trend[2].

Research and Development

Investments in research and development are crucial for the antimalarial drugs market. Companies like GSK are planning for multiple major launches from 2025, including new vaccines and specialty medicines for infectious diseases, which will likely include advancements in antimalarial treatments[2].

Challenges and Restraints

High Cost of Treatment

One of the significant restraints on the market is the high cost of antimalarial treatments, which can be prohibitive in many developing countries. This limits the accessibility of drugs like MALARONE to a broader population[3][4].

Resistance and Side Effects

The emergence of drug-resistant strains of the malaria parasite and potential side effects of antimalarial drugs are other challenges. These factors necessitate continuous research into new and more effective treatments[1][4].

Regional Dynamics

Geographic Distribution

The antimalarial drugs market is geographically diverse, with the Latin America, Middle East, and Africa (LAMEA) region expected to account for a significant share due to the high prevalence of malaria in these areas[4].

Key Players and Competitive Landscape

The antimalarial drugs market is competitive, with several key players including GSK, Novartis AG, Pfizer Inc., and others. These companies are involved in ongoing research and development to improve existing treatments and develop new ones[4].

Government and Non-Government Initiatives

Organizations like the Medicines for Malaria Venture (MMV) play a crucial role in the development and distribution of antimalarial drugs. MMV's financial reports indicate significant investments in portfolio expenditures, including discovery, development, and access & product management projects, which support the overall market growth[5].

Future Outlook

The future of the antimalarial drugs market, including MALARONE, looks promising due to several factors:

Increasing Demand

The persistent global burden of malaria ensures a continuous demand for effective treatments.

Regulatory Approvals

Regulatory approvals for novel antimalarial drugs and expanded indications will further drive market growth[1].

Technological Advancements

Advancements in drug formulations and combinations, such as those seen in MALARONE, will continue to improve treatment outcomes and drive market expansion.

Key Takeaways

• The global antimalarial drugs market is expected to grow at a CAGR of 4.26% from 2024 to 2030.
• MALARONE, a combination of atovaquone and proguanil, is a significant player in this market.
• High healthcare spending, government initiatives, and ongoing R&D efforts drive market growth.
• Challenges include high treatment costs and the emergence of drug-resistant strains.
• The LAMEA region is expected to account for a significant market share due to high malaria prevalence.

FAQs

What is the current market size of the global antimalarial drugs market?

The global antimalarial drugs market was valued at USD 989.7 million in 2023[1].

What is the expected growth rate of the antimalarial drugs market?

The market is expected to grow at a CAGR of 4.26% from 2024 to 2030[1].

What are the main drivers of the antimalarial drugs market?

The main drivers include the rising prevalence of malaria, increasing healthcare spending, and government initiatives for malaria control and awareness[1][3][4].

Which regions are expected to dominate the antimalarial drugs market?

The LAMEA region is expected to account for a significant share of the market due to the high prevalence of malaria[4].

What are the challenges facing the antimalarial drugs market?

High treatment costs and the emergence of drug-resistant strains are significant challenges[3][4].

Sources

1. Grand View Research - Anti-malarial Drugs Market Size, Share, Growth Report, 2030
2. GSK - Q4 2023 Announcement
3. The Insight Partners - Drugs For Malaria Market Key Players Analysis 2031
4. GlobeNewswire - At 4.2% CAGR, Global Antimalarial Drugs Market Size to Hit $1207.51 Million by 2028
5. Medicines for Malaria Venture - Financial view - Medicines for Malaria Venture Annual Report 2022