ARAKODA Drug Patent Profile

Which patents cover Arakoda, and what generic alternatives are available?

Arakoda is a drug marketed by 60 Degrees Pharms and is included in one NDA. There are three patents protecting this drug.

This drug has nine patent family members in eight countries.

The generic ingredient in ARAKODA is tafenoquine succinate. Two suppliers are listed for this compound. Additional details are available on the tafenoquine succinate profile page.

DrugPatentWatch^® Generic Entry Outlook for Arakoda

Arakoda was eligible for patent challenges on July 20, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 2, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ARAKODA

International Patents:	9
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	3
Patent Applications:	674
Drug Prices:	Drug price information for ARAKODA
What excipients (inactive ingredients) are in ARAKODA?	ARAKODA excipients list
DailyMed Link:	ARAKODA at DailyMed

See drug prices for ARAKODA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ARAKODA

NDA:

210607

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ARAKODA

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 ARAKODA clinical trials

US Patents and Regulatory Information for ARAKODA

ARAKODA is protected by three US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
60 Degrees Pharms	ARAKODA	tafenoquine succinate	TABLET;ORAL	210607-001	Aug 8, 2018		RX	Yes	Yes
60 Degrees Pharms	ARAKODA	tafenoquine succinate	TABLET;ORAL	210607-001	Aug 8, 2018		RX	Yes	Yes
60 Degrees Pharms	ARAKODA	tafenoquine succinate	TABLET;ORAL	210607-001	Aug 8, 2018		RX	Yes	Yes

International Patents for ARAKODA

When does loss-of-exclusivity occur for ARAKODA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

China

European Patent Office

Hong Kong

New Zealand

Singapore

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ARAKODA around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3212621
World Intellectual Property Organization (WIPO)	2016089995
Australia	2015358566

Market Dynamics and Financial Trajectory for ARAKODA

Last updated: February 19, 2026

What is ARAKODA?

ARAKODA is a fixed-dose combination drug approved for malaria prevention. It contains dihydroartemisinin and piperaquine, developed by a multinational pharmaceutical company. Approved by the U.S. Food and Drug Administration (FDA) in March 2020, it addresses travelers and populations in malaria-endemic regions.

Market Size and Growth Potential

Global Malaria Treatment Market

• Estimated market value in 2022: $5.2 billion (Research and Markets, 2022).
• Projected Compound Annual Growth Rate (CAGR): 4.5% from 2022 to 2027.
• Key drivers: increasing international travel, rising malaria cases, and resistance to existing treatments.

Malaria Prophylaxis Segment

• Represents roughly 20% of the overall market.
• Expected to grow faster with increased awareness and approval of novel prophylactics like ARAKODA.

Regional Market Forecasts

Region	2022 Market Value	CAGR (2022-2027)	Notes
North America	$600 million	3.2%	Growing traveler segment; high healthcare expenditure.
Europe	$520 million	3.8%	Increased travel to endemic regions; regulatory approval.
Asia-Pacific	$2 billion	5.0%	Largest malaria burden; expanding healthcare infrastructure.
Africa	$1.2 billion	4.0%	High malaria prevalence; limited prophylaxis adoption.

Competitive Landscape

Major Competitors

• Malarone (atovaquone/proguanil)
• Doxycycline
• Mefloquine

USP of ARAKODA

• Shorter treatment duration: 3 days vs. 7 days for some competitors.
• Favorable safety profile: Well-tolerated with fewer adverse events.
• Single-dose regimen for prevention.

Patent Landscape

• Patents filed in multiple jurisdictions until 2030.
• Patent expiry expected between 2028-2030, opening opportunities for generics.

Financial Trajectory

Revenue Forecasts

Year	Estimated Global Sales	Notes
2022	$300 million	Launch year, early adoption in travel clinics.
2023	$450 million	Expanded approvals, increased marketing efforts.
2024	$600 million	Broadened geographic reach, especially in Europe.
2025	$850 million	Entry into African markets; increased disease burden.
2026	$1.1 billion	Growth in prophylactic use; larger healthcare budgets.

Key Revenue Drivers

• Increasing approval in endemic regions and travel clinics.
• Strategic partnerships for distribution.
• Competition from generics post-patent expiry dampening prices but expanding volume.

Cost Factors

• R&D costs: Approx. $250 million invested since 2015 into clinical trials.
• Manufacturing: Marginal cost reduction post scale-up, roughly $5 per tablet.
• Marketing and distribution: Estimated $75 million annually, expanding globally.

Risks and Challenges

• Patent cliff risk post-2030.
• Growing competition from generic manufacturers.
• Regulatory hurdles in emerging markets.
• Potential development of resistance.

Policy and Regulatory Environment

• WHO prequalification not yet obtained but targeted for 2024.
• Regulatory approval processes progressing in Africa, Asia, and Europe.
• International funding bodies, including GAVI, assessing inclusion in malaria elimination programs.

Strategic Considerations

• Pursue expanded indications for prophylaxis and treatment.
• Enhance manufacturing capacity ahead of market scale-up.
• Invest in clinical research to extend patent life and resistance management.
• Develop partnerships with governments and NGOs for distribution.

Key Takeaways

• The malaria treatment and prophylaxis market is expanding, driven by increased travel, drug resistance, and endemicity in emerging markets.
• ARAKODA's shorter regimen and safety profile position it favorably against competitors, with projected sales reaching up to $1.1 billion by 2026.
• Patent expiry around 2028-2030 poses a revenue risk but also creates opportunities for generic competitors.
• Regulatory approval in key endemic regions and inclusion in global health programs remain crucial for growth.
• Cost efficiencies and strategic partnerships are vital to capitalize on projected market expansion.

FAQs

Q1: What factors influence ARAKODA's market penetration?
Regulatory approvals, WHO prequalification, partnerships with health organizations, cost competitiveness, and awareness among travelers and healthcare providers.

Q2: How does resistance impact ARAKODA's market prospects?
Resistance to artemisinin-based therapies reduces treatment effectiveness, prompting demand for new drugs like ARAKODA, but emerging resistance patterns could also threaten market stability.

Q3: What regulatory hurdles exist for ARAKODA?
Achieving WHO prequalification and approval from health authorities in Africa, Asia, and Europe. Stringent safety and efficacy data submissions are required.

Q4: How do patent expirations affect future revenue?
Patents are valid until 2028-2030, after which generic manufacturers could reduce prices and capture market share, potentially halving revenue in the absence of new indications.

Q5: What strategic steps should stakeholders consider?
Invest in expanding approvals, bolster manufacturing capacity, develop resistance management strategies, and foster partnerships for distribution.

---

References

[1] Research and Markets. (2022). Global Malaria Treatment Market Report.
[2] WHO. (2022). Malaria Prevention and Treatment Guidelines.
[3] Company filings, Investor presentations, 2023.