ATOVAQUONE - Generic Drug Details

What are the generic sources for atovaquone and what is the scope of patent protection?

Atovaquone is the generic ingredient in five branded drugs marketed by Abhai Llc, Abon Pharms Llc, Amneal Pharms, Apotex, Bionpharma, Chartwell Rx, Glenmark Speclt, Hetero Labs Ltd Iii, Lupin Ltd, Glaxosmithkline Llc, Glenmark Pharms Ltd, Mylan, and Glaxosmithkline, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for atovaquone. Twenty suppliers are listed for this compound.

Summary for ATOVAQUONE

US Patents:	0
Tradenames:	5
Applicants:	13
NDAs:	14
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	166
Clinical Trials:	42
Patent Applications:	6,800
Drug Prices:	Drug price trends for ATOVAQUONE
What excipients (inactive ingredients) are in ATOVAQUONE?	ATOVAQUONE excipients list
DailyMed Link:	ATOVAQUONE at DailyMed

See drug prices for ATOVAQUONE

Recent Clinical Trials for ATOVAQUONE

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 ATOVAQUONE clinical trials

Pharmacology for ATOVAQUONE

Drug Class

Antimalarial Antiprotozoal

Medical Subject Heading (MeSH) Categories for ATOVAQUONE

Anti-Infective Agents

Antimalarials

Enzyme Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ATOVAQUONE

P01AX	Other agents against amoebiasis and other protozoal diseases
P01A	AGENTS AGAINST AMOEBIASIS AND OTHER PROTOZOAL DISEASES
P01	ANTIPROTOZOALS
P	Antiparasitic products, insecticides and repellents

Paragraph IV (Patent) Challenges for ATOVAQUONE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MEPRON	Oral Suspension	atovaquone	750 mg/5 mL	020500	1	2009-10-20

US Patents and Regulatory Information for ATOVAQUONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	atovaquone; proguanil hydrochloride	TABLET;ORAL	202362-002	May 27, 2014	AB	RX	No	No
Mylan	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	atovaquone; proguanil hydrochloride	TABLET;ORAL	202362-001	May 27, 2014	AB	RX	No	No
Apotex	ATOVAQUONE	atovaquone	SUSPENSION;ORAL	209750-001	Oct 11, 2017	AB	RX	No	No
Glenmark Pharms Ltd	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	atovaquone; proguanil hydrochloride	TABLET;ORAL	091211-001	Jan 12, 2011	AB	RX	No	No
Bionpharma	ATOVAQUONE	atovaquone	SUSPENSION;ORAL	212918-001	Mar 30, 2021	AB	RX	No	No
Abhai Llc	ATOVAQUONE	atovaquone	SUSPENSION;ORAL	210510-001	May 31, 2019	AB	RX	No	No
Glenmark Speclt	ATOVAQUONE	atovaquone	SUSPENSION;ORAL	209685-001	Nov 21, 2018	AB	RX	No	No

Expired US Patents for ATOVAQUONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Llc	MEPRON	atovaquone	TABLET;ORAL	020259-001	Nov 25, 1992	5,053,432*PED
Glaxosmithkline Llc	MEPRON	atovaquone	SUSPENSION;ORAL	020500-001	Feb 8, 1995	4,981,874*PED
Glaxosmithkline Llc	MEPRON	atovaquone	TABLET;ORAL	020259-001	Nov 25, 1992	4,981,874*PED
Glaxosmithkline Llc	MEPRON	atovaquone	SUSPENSION;ORAL	020500-001	Feb 8, 1995	6,649,659*PED
Glaxosmithkline Llc	MEPRON	atovaquone	SUSPENSION;ORAL	020500-001	Feb 8, 1995	5,053,432*PED

ATOVAQUONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Atovaquone

Introduction

Atovaquone is a versatile antiparasitic drug used primarily for the treatment of malaria, pneumocystis pneumonia, and other infections. Understanding its market dynamics and financial trajectory is crucial for stakeholders, including pharmaceutical companies, investors, and healthcare providers.

Global Market Size and Growth

As of 2024, the global Atovaquone and Proguanil market size was estimated at USD 185.6 million. This market is projected to grow significantly, with a compound annual growth rate (CAGR) of 11.50% from 2024 to 2031, reaching an estimated USD 397.65 million by 2031[1].

Regional Market Breakdown

North America

North America holds a substantial share of the global market, accounting for more than 40% of the global revenue. In 2024, the North American market size was USD 74.24 million, with the United States being the largest contributor at USD 58.58 million. This region is expected to grow at a CAGR of 9.7% from 2024 to 2031[1].

Asia Pacific

The Asia Pacific region is another significant market, holding around 23% of the global revenue. In 2024, the market size in this region was USD 42.69 million, with countries like China, Japan, and India contributing substantially. The Asia Pacific market is expected to grow at a CAGR of 13.5% from 2024 to 2031, driven by countries such as India, which has a CAGR of 15.3% during the same period[1].

Latin America and Middle East & Africa

Latin America and the Middle East & Africa also contribute to the global market, albeit with smaller shares. Latin America accounted for around 5% of the global revenue with a market size of USD 9.28 million in 2024, growing at a CAGR of 10.9%. The Middle East and Africa held around 2% of the global revenue with a market size of USD 3.71 million in 2024, growing at a CAGR of 11.2% from 2024 to 2031[1].

Drivers of Market Growth

Rising Malaria Burden

The increasing incidence of malaria, particularly in regions like Africa and Asia, is a significant driver of the Atovaquone market. Malaria remains a major public health concern, and the need for effective antimalarial drugs like Atovaquone and Proguanil continues to drive market growth[1][5].

Expanding Use in Other Infections

Atovaquone's efficacy in treating other infections, such as pneumocystis pneumonia, also contributes to its market growth. This drug is particularly important for patients with compromised immunity, such as those with HIV/AIDS[4].

Research and Development

Recent studies have explored the potential of Atovaquone in reducing SARS-CoV-2 replication, which could open new avenues for its use and further boost market demand[2].

Key Players and Export Insights

Major Exporting Countries

India is a leading exporter of Atovaquone API, with companies like Divis Laboratories, Glenmark Pharmaceuticals, and Hetero Drugs being major players. The export quantity from India has shown fluctuations but remains significant, with Canada and the USA being the biggest importing countries[4].

Major Importing Countries

The United States, Hungary, Czech Republic, and other countries are significant importers of Atovaquone from India. This global trade network underscores the drug's widespread use and demand[4].

Competitive Landscape

The Atovaquone market is characterized by a competitive landscape involving several key players. These companies are focused on enhancing production, improving distribution networks, and expanding their market share. The competitive environment is also driven by research and development efforts to explore new applications and improve the drug's efficacy[3][4].

Financial Performance and Projections

Revenue Projections

The projected growth of the Atovaquone and Proguanil market from USD 185.6 million in 2024 to USD 397.65 million by 2031 indicates a robust financial trajectory. This growth is driven by increasing demand, expanding use cases, and favorable market conditions[1].

Regional Financial Performance

North America, with its significant market share, contributes substantially to the overall revenue. The Asia Pacific region, however, is expected to show the highest growth rate, driven by emerging markets like India and China[1].

Challenges and Opportunities

Regulatory Environment

The pharmaceutical industry is heavily regulated, and changes in regulatory policies can impact the market. For instance, the FDA's approval of IV artesunate for severe malaria treatment could influence the use of Atovaquone and Proguanil in certain cases[5].

Resistance and Side Effects

The development of resistance to antimalarial drugs is a continuous challenge. However, as of the latest reports, no specimens tested contained markers for atovaquone resistance, which is a positive indicator for its continued use[5].

Emerging Applications

Research into Atovaquone's antiviral properties, particularly against SARS-CoV-2, presents new opportunities for market expansion. If these studies yield positive results, it could significantly boost the drug's market potential[2].

Key Takeaways

• The global Atovaquone and Proguanil market is projected to grow from USD 185.6 million in 2024 to USD 397.65 million by 2031.
• North America and the Asia Pacific are key regions driving market growth.
• The rising malaria burden and expanding use in other infections are significant drivers of market growth.
• India is a major exporter of Atovaquone API, with the USA and Canada being major importers.
• The competitive landscape is characterized by several key players focusing on production, distribution, and research.

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 for the Atovaquone and Proguanil market?

The market is expected to grow at a compound annual growth rate (CAGR) of 11.50% from 2024 to 2031[1].

Which regions are the major contributors to the Atovaquone market?

North America and the Asia Pacific are the major contributors, with North America holding more than 40% of the global revenue and the Asia Pacific holding around 23%[1].

What are the primary drivers of the Atovaquone market growth?

The rising malaria burden and the drug's efficacy in treating other infections, such as pneumocystis pneumonia, are primary drivers of market growth[1][4].

Has Atovaquone shown any potential in treating COVID-19?

Yes, recent studies have shown that Atovaquone can reduce SARS-CoV-2 replication in human lung cells, suggesting potential antiviral properties[2].

Which countries are major exporters and importers of Atovaquone API?

India is a major exporter, while the USA and Canada are significant importers of Atovaquone API[4].

Sources

1. Cognitive Market Research: Atovaquone and Proguanil Market Report 2024 (Global Edition)
2. MDPI: Atovaquone and Berberine Chloride Reduce SARS-CoV-2 Replication In Vitro
3. Cognitive Market Research: Global Atovaquone Market Report 2024 Edition
4. Macsen Lab: Atovaquone | Market Insights, Price and Trends of this drug
5. CDC: Malaria Surveillance — United States, 2018