COARTEM Drug Patent Profile

When do Coartem patents expire, and what generic alternatives are available?

Coartem is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in COARTEM is artemether; lumefantrine. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the artemether; lumefantrine profile page.

Summary for COARTEM

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	30
Clinical Trials:	91
Drug Prices:	Drug price information for COARTEM
What excipients (inactive ingredients) are in COARTEM?	COARTEM excipients list
DailyMed Link:	COARTEM at DailyMed

See drug prices for COARTEM

Recent Clinical Trials for COARTEM

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

Sponsor	Phase
MMV, EDCTP, WANECAM	Phase 3
Novartis Pharmaceuticals	Phase 3
Global Fund	Phase 4

See all COARTEM clinical trials

Pharmacology for COARTEM

Drug Class

Antimalarial

US Patents and Regulatory Information for COARTEM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	COARTEM	artemether; lumefantrine	TABLET;ORAL	022268-001	Apr 7, 2009		RX	Yes	Yes

Expired US Patents for COARTEM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	COARTEM	artemether; lumefantrine	TABLET;ORAL	022268-001	Apr 7, 2009

International Patents for COARTEM

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

Country	Patent Number	Title	Estimated Expiration
Denmark	0500823
Australia	642747
Greece	3019313
Germany	69117922
Ireland	72095	Antimalarial compositions

Supplementary Protection Certificates for COARTEM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0500823	SPC/GB00/013	United Kingdom		PRODUCT NAME: ARTEMETHER AND LUMEFANTRIN; REGISTERED: CH (IKS) 54594 01 19990122; UK PL 00101/0566 19991130
0500823	2001C/043	Belgium		PRODUCT NAME: ARTEMETHER, LUMEFANTRINE; NAT. REGISTRATION NO/DATE: 206 IS 300 F 3 20010514; FIRST REGISTRATION: CH 54594 19990122
0500823	C300048	Netherlands		PRODUCT NAME: ARTEMETHERUM EN LUMEFANTRINUM, DESGEWENST IN DE VORM VAN EEN FA RMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER ARTEMETHERUM EN LUMEFANTRINUM; NATL. REGISTRATION NO/DATE: RVG 25773 20010123; FIRST REGISTRATION: CH 54594 19990122

COARTEM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Coartem (Artemether/Lumefantrine)

Overview of Coartem

Coartem, a combination therapy of artemether and lumefantrine, is a pivotal drug in the antimalarial market. Developed and widely distributed by Novartis, it has become a gold standard for the treatment of malaria, particularly in regions with high malaria prevalence.

Market Size and Growth

The global Coartem market is part of the broader antimalarial drugs market, which is expected to witness significant growth in the coming years.

• Current Market Size: The global antimalarial drugs market, which includes Coartem, was valued at USD 877.59 million in 2023[1].
• Forecasted Growth: This market is anticipated to grow at a CAGR of 4.6% from 2023 to 2030, reaching a valuation of USD 1,202.21 million by 2030[1].

Regional Dynamics

Asia-Pacific

The Asia-Pacific region is expected to be the fastest-growing market for antimalarial drugs, including Coartem. This growth is driven by the high incidence of malaria in countries such as India, Indonesia, and other Southeast Asian nations[1].

Europe

Europe remains the largest market for antimalarial drugs, including Coartem, due to the presence of major pharmaceutical companies and a well-established healthcare infrastructure[1].

Middle East & Africa

This region also presents significant growth potential due to the high prevalence of malaria. For instance, the Middle East & Africa market for artemisinin antimalarial drugs, which includes Coartem, was valued at USD 231.5 million in 2023 and is expected to grow at a CAGR of 4.1% between 2024 and 2032[4].

Key Drivers of Growth

Rising Prevalence of Malaria

The increasing number of malaria cases, particularly in tropical and subtropical regions, is a major driver of the Coartem market. For example, in 2022, an estimated 249 million malaria cases occurred globally, leading to 608,000 malaria deaths[4].

Government Initiatives

Government initiatives and funding for research and development of new antimalarial drugs, as well as programs to distribute existing drugs in high-risk areas, significantly boost the demand for Coartem[1].

Increased Awareness

Public awareness of malaria and its impact on public health has increased, leading to higher demand for effective treatments like Coartem[1].

Research and Development

Ongoing research and development efforts to enhance the efficacy and safety profiles of artemisinin-based combination therapies (ACTs), such as Coartem, further drive market growth[4].

Technological Advancements

Advancements in diagnostic tools and treatments have increased the effectiveness of Coartem, leading to its increased adoption[1].

Financial Performance of Novartis

Novartis, the primary distributor of Coartem, has seen significant financial performance in recent years.

• Net Sales: Novartis reported higher net sales, partly offset by higher R&D investments. For instance, in the Q2 2024 report, core operating income was USD 5.0 billion, with a core operating income margin of 39.6% of net sales[2].
• Acquisitions and Investments: Novartis has made strategic acquisitions, such as the acquisition of Coartem from Guangzhou Pharmaceuticals Corporation in 2001, which has contributed to its market presence and revenue growth[1].

Competitive Landscape

The competitive landscape of the antimalarial drugs market, including Coartem, is characterized by a mix of pharmaceutical giants and smaller biotech firms.

• Key Players: Novartis and Sanofi are leading suppliers of artemisinin-based combination therapies (ACTs). These companies leverage their extensive distribution networks and substantial R&D investments to maintain a competitive edge[4].
• Strategic Collaborations: Strategic collaborations, partnerships, and ongoing research into novel drug combinations and delivery methods are pivotal in shaping the competitive dynamics and driving advancements in the market[4].

Market Segments

The Coartem market is segmented based on several factors:

• Application: Hospital pharmacy, retail pharmacy, and online pharmacy are key segments. The hospital pharmacy segment is particularly significant due to the critical nature of malaria treatment[3].
• Product: The market is segmented into artemether and lumefantrine, with the combination therapy being the most dominant form[3].
• Geography: North America, Europe, Asia-Pacific, Middle East & Africa, and South & Central America are the key geographical regions. The Asia-Pacific and Middle East & Africa regions are expected to drive significant growth[3].

Challenges and Threats

Despite the growth potential, the Coartem market faces several challenges:

• Resistance to Artemisinin: The emergence of resistance to artemisinin in some regions poses a significant threat to the market[4].
• Regulatory Hurdles: Strict regulatory requirements and the need for continuous monitoring and approval can slow down market growth[1].
• Economic Factors: Economic instability and limited healthcare budgets in some countries can affect the demand for Coartem[1].

Key Takeaways

• The Coartem market is expected to grow significantly, driven by the rising prevalence of malaria, government initiatives, increased awareness, and ongoing R&D efforts.
• Novartis, as the primary distributor, has seen strong financial performance and continues to invest in R&D and strategic acquisitions.
• The market is segmented by application, product, and geography, with Asia-Pacific and Middle East & Africa regions showing high growth potential.
• Despite growth, the market faces challenges such as artemisinin resistance and regulatory hurdles.

FAQs

What is the current market size of the antimalarial drugs market, which includes Coartem?

The global antimalarial drugs market was valued at USD 877.59 million in 2023[1].

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

The market is anticipated to grow at a CAGR of 4.6% from 2023 to 2030[1].

Which region is expected to be the fastest-growing market for Coartem?

The Asia-Pacific region is expected to be the fastest-growing market for antimalarial drugs, including Coartem[1].

What are the key drivers of growth for the Coartem market?

Key drivers include the rising prevalence of malaria, government initiatives, increased awareness, and ongoing R&D efforts[1][4].

Who are the major players in the Coartem market?

Major players include Novartis, Sanofi, Pfizer, GlaxoSmithKline, and Cipla[1].

What are the significant threats to the Coartem market?

Significant threats include the emergence of resistance to artemisinin, regulatory hurdles, and economic factors such as limited healthcare budgets[1][4].

Sources

1. Custom Market Insights: Global Antimalarial Drugs Market Size, Trends, Share 2030.
2. Novartis: Q2 2024 Interim Financial Report – Supplementary Data.
3. Market Research Intellect: Coartem (Artemether/Lumefantrine) Market Size, Share and Forecast.
4. Global Market Insights: Artemisinin Antimalarial Drugs Market Size & Share Report - 2032.