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Last Updated: December 22, 2024

ATOVAQUONE AND PROGUANIL HYDROCHLORIDE Drug Patent Profile


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When do Atovaquone And Proguanil Hydrochloride patents expire, and what generic alternatives are available?

Atovaquone And Proguanil Hydrochloride is a drug marketed by Glenmark Pharms Ltd and Mylan and is included in two NDAs.

The generic ingredient in ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 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 Atovaquone And Proguanil Hydrochloride

A generic version of ATOVAQUONE AND PROGUANIL HYDROCHLORIDE was approved as atovaquone; proguanil hydrochloride by GLENMARK PHARMS LTD on January 12th, 2011.

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Summary for ATOVAQUONE AND PROGUANIL HYDROCHLORIDE
Drug patent expirations by year for ATOVAQUONE AND PROGUANIL HYDROCHLORIDE
Recent Clinical Trials for ATOVAQUONE AND PROGUANIL HYDROCHLORIDE

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

SponsorPhase
Australian Defence Force Malaria and Infectious Disease Institute (ADF MIDI)Phase 4
Naval Medical Research Unit TWO (NAMRU-2)Phase 4
Naval Medical Research CenterPhase 4

See all ATOVAQUONE AND PROGUANIL HYDROCHLORIDE clinical trials

Pharmacology for ATOVAQUONE AND PROGUANIL HYDROCHLORIDE

US Patents and Regulatory Information for ATOVAQUONE AND 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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mylan ATOVAQUONE AND PROGUANIL HYDROCHLORIDE atovaquone; proguanil hydrochloride TABLET;ORAL 202362-002 May 27, 2014 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Glenmark Pharms Ltd ATOVAQUONE AND PROGUANIL HYDROCHLORIDE atovaquone; proguanil hydrochloride TABLET;ORAL 091211-001 Jan 12, 2011 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mylan ATOVAQUONE AND PROGUANIL HYDROCHLORIDE atovaquone; proguanil hydrochloride TABLET;ORAL 202362-001 May 27, 2014 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

ATOVAQUONE AND PROGUANIL HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Atovaquone and Proguanil Hydrochloride: Market Dynamics and Financial Trajectory

Introduction

Atovaquone and Proguanil Hydrochloride, commonly known as Malarone, is a potent antimalarial medication that has garnered significant attention in the global pharmaceutical market. This combination drug is pivotal in the treatment and prophylaxis of malaria, particularly in regions where the disease is prevalent. Here, we delve into the market dynamics and financial trajectory of Atovaquone and Proguanil Hydrochloride.

Global Market Size and Growth

The global Atovaquone and Proguanil market was estimated to be worth USD 185.6 million in 2024. This market is projected to grow substantially, driven by the increasing burden of malaria and the need for effective antimalarial treatments. By 2031, the market is expected to reach USD 397.65 million, growing at a compound annual growth rate (CAGR) of 11.50% from 2024 to 2031[1].

Regional Market Analysis

North America

North America dominates the Atovaquone and Proguanil market, accounting for more than 40% of the global revenue with a market size of USD 74.24 million in 2024. This region is expected to grow at a CAGR of 9.7% from 2024 to 2031. The strong healthcare infrastructure and high disposable incomes in this region contribute significantly to the demand for this medication[1].

Europe

Europe is emerging as the fastest-growing region in the Atovaquone and Proguanil market. The increasing global travel to malaria-endemic areas and a heightened focus on malaria prevention measures are key drivers. Europe's robust healthcare structures and emphasis on travel medicine further boost the demand for reliable antimalarial medications like Atovaquone/Proguanil[1].

Asia Pacific

The Asia Pacific region holds around 23% of the global revenue, with a market size of USD 42.69 million in 2024. This region is expected to grow at a CAGR of 13.5% from 2024 to 2031, driven by high growth potential, particularly in countries like China and Japan[1].

Latin America and Middle East & Africa

Latin America accounts for around 5% of the global revenue, with a market size of USD 9.28 million in 2024, and is expected to grow at a CAGR of 10.9% from 2024 to 2031. The Middle East and Africa, though smaller, still contribute significantly, with a market size of USD 3.71 million in 2024 and a CAGR of 11.2% from 2024 to 2031[1].

Key Drivers of Market Growth

Increasing Malaria Burden

The rising incidence of malaria, particularly in regions with drug-resistant strains, is a major driver of the Atovaquone and Proguanil market. The drug's efficacy against resistant strains makes it a preferred choice for both treatment and prophylaxis[2].

Global Travel

Increased global travel to malaria-endemic areas has heightened the demand for effective antimalarial medications. Travelers, especially those from regions with robust healthcare systems, are more likely to seek reliable preventive measures, contributing to the market growth[1].

Healthcare Infrastructure

The strong healthcare infrastructure in regions like North America and Europe supports the demand for Atovaquone and Proguanil. High disposable incomes and a focus on preventive healthcare further drive the market[1].

Competitive Landscape

The Atovaquone and Proguanil market is characterized by the presence of several key players, including GlaxoSmithKline (GSK), Glenmark, Mylan Pharmaceuticals, and Hetero. These companies play a crucial role in manufacturing and distributing the medication globally[3].

Product Efficacy and Safety

Mechanism of Action

Atovaquone and Proguanil work synergistically to inhibit parasite mitochondrial electron transport, making them highly effective against Plasmodium falciparum. Clinical trials have shown that the combination is significantly more effective than other antimalarial drugs like mefloquine and chloroquine[2].

Clinical Efficacy

The overall cure rate for Atovaquone and Proguanil in treating acute, uncomplicated malaria is over 98% in more than 500 patients. This high efficacy rate underscores its importance in malaria treatment protocols[2].

Safety Profile

The combination of Atovaquone and Proguanil has a favorable safety profile. Common adverse effects include abdominal pain, anorexia, nausea, vomiting, and diarrhea, which occur with similar frequency to comparator drugs. Serious adverse effects are rare and include conditions like hepatitis and blood disorders, particularly in patients with severe renal impairment[2][4].

Market Segments

By Type

The market is segmented into different formulations, including the standard 250 mg/100 mg tablets (Malarone) and the pediatric formulation 62.5 mg/25 mg tablets (Malarone Junior)[4].

By Application

The primary applications are in adult and pediatric populations. The drug is used for both the treatment and prophylaxis of malaria, catering to a broad range of patients[3].

Financial Projections

Revenue Forecast

By 2031, the global Atovaquone and Proguanil market is expected to reach USD 397.65 million, growing at a CAGR of 11.50% from 2024 to 2031. This significant growth is driven by the increasing demand for effective antimalarial treatments and the expanding market in various regions[1].

Regional Growth

Asia Pacific is expected to show high growth potential, with a CAGR of 13.5% from 2024 to 2031. China, in particular, is forecasted to contribute substantially to this growth, driven by its large population and increasing healthcare expenditure[1][5].

Challenges and Opportunities

Resistance and Side Effects

While Atovaquone and Proguanil are highly effective, there is a risk of resistance development. Monitoring for resistance and managing side effects, especially in patients with renal or hepatic impairment, are critical challenges. However, these challenges also present opportunities for research and development of new formulations and treatment protocols[2][4].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics. Compliance with regulatory standards and obtaining approvals in various regions can be both a challenge and an opportunity for market expansion[3].

Key Takeaways

  • The global Atovaquone and Proguanil market is projected to grow significantly, driven by the increasing malaria burden and global travel.
  • North America and Europe are key markets, while Asia Pacific shows high growth potential.
  • The combination of Atovaquone and Proguanil has a synergistic effect and a favorable safety profile.
  • Key players like GSK, Glenmark, Mylan Pharmaceuticals, and Hetero dominate the market.
  • The market is segmented by type and application, with a strong focus on both adult and pediatric populations.

FAQs

What is the current global market size for Atovaquone and Proguanil?

The global Atovaquone and Proguanil market size was estimated at USD 185.6 million in 2024[1].

What is the projected growth rate of the Atovaquone and Proguanil market?

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

Which regions dominate the Atovaquone and Proguanil market?

North America and Europe are the dominant regions, with Asia Pacific showing high growth potential[1].

What are the common adverse effects of Atovaquone and Proguanil?

Common adverse effects include abdominal pain, anorexia, nausea, vomiting, and diarrhea[2][4].

Who are the key players in the Atovaquone and Proguanil market?

Key players include GlaxoSmithKline (GSK), Glenmark, Mylan Pharmaceuticals, and Hetero[3].

Sources

  1. Cognitive Market Research: Atovaquone and Proguanil Market Report 2024 (Global Edition)
  2. PubMed: Malarone (atovaquone and proguanil hydrochloride): a review of its pharmacology and therapeutic efficacy
  3. Valuates Reports: Atovaquone and Proguanil - Market Size
  4. Children’s Antimicrobial Management Program (ChAMP): Atovaquone with Proguanil Monograph - Paediatric
  5. QYResearch: Atovaquone and Proguanil - Global Market Insights and Sales Forecast

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