tafenoquine succinate - Profile

What are the generic sources for tafenoquine succinate and what is the scope of freedom to operate?

Tafenoquine succinate is the generic ingredient in two branded drugs marketed by 60 Degrees Pharms and Glaxosmithkline, and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tafenoquine succinate has nine patent family members in eight countries.

Summary for tafenoquine succinate

International Patents:	9
US Patents:	3
Tradenames:	2
Applicants:	2
NDAs:	2

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

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.

US Patents and Regulatory Information for tafenoquine succinate

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
Glaxosmithkline	KRINTAFEL	tafenoquine succinate	TABLET;ORAL	210795-001	Jul 20, 2018		RX	Yes	Yes

International Patents for tafenoquine succinate

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2016089995
Australia	2015358566
New Zealand	731813
China	107683278
Hong Kong	1243704
European Patent Office	3212621

Investment Scenario and Fundamentals Analysis for Tafenoquine Succinate

Last updated: March 11, 2026

What is Tafenoquine Succinate?

Tafenoquine succinate is an antimalarial drug developed by GSK (GlaxoSmithKline) with the primary indication for radical cure of Plasmodium vivax malaria and prophylaxis. It is a long-acting 8-aminoquinoline, offering an alternative to primaquine, with improved dosing regimen and potentially better compliance.

Market Potential and Commercial Landscape

Global Malaria Market Overview

• The global malaria treatment market was valued at around USD 2.4 billion in 2020.
• Expected Compound Annual Growth Rate (CAGR): approximately 5% from 2021 to 2026[1].

Key Market Segments for Tafenoquine

• Radical Cure of P. vivax Malaria: Significant because of P. vivax’s ability to relapse.
• Malaria Prophylaxis: For travelers to endemic regions.
• Potential Expansion Areas: Treatment of hypnozoite forms and emerging indications ([2]).

Geographic Markets

Region	Market Size (USD Billion)	Growth Outlook
North America	0.8	Increased adoption in U.S. due to malaria risk awareness
Europe	0.4	Growing use in travelers’ health segment
Africa	0.5	Limited due to low registration but high prevalence of P. vivax
Asia-Pacific	0.7	Rapidly growing, especially in India and Southeast Asia

Competitive Landscape

• Primaquine dominates current radical cure therapy.
• Other options include chloroquine and newer therapies under development.
• Tafenoquine’s advantages include a single-dose regimen over multiple doses of primaquine.

Regulatory and Commercial Status

• FDA approval granted in 2018 for P. vivax radical cure.
• EMA approval issued in 2019.
• GSK has pursued orphan drug designation and sought broad regulatory pathways, indicating focus on global markets.

From a Fundamentals Perspective

R&D and Production

• Development Costs: High, with clinical trials costing USD 200-300 million.
• Manufacturing: Requires specialized facilities with Good Manufacturing Practice (GMP) compliance.
• Patent Status: Patents expiring in the mid-2020s; generics likely to enter thereafter, impacting pricing and margins.

Pricing and Reimbursement

• Pricing in the U.S.: Approximate wholesale acquisition cost (WAC) is USD 1,200–1,500 for a single dose.
• Reimbursement landscape: Favorable in developed markets; coverage varies in Africa and Asia-Pacific.

Investment Risks

• Patent expiration could lead to price erosion.
• Regulatory hurdles in emerging markets.
• Market penetration barriers due to existing alternatives and prescription habits.

Financial Metrics

Metric	Data Points
Estimated global sales (2022)	USD 300 million (initial commercialization phase)
Cost of Goods Sold (COGS)	Approximately 20% of sale price
Gross margin estimate	75% (initial phase)
Market penetration rate	10–15% in targeted indications within 5 years

Key Considerations for Investors

• Patent lifetime: Critical to profitability; expected to last until 2024–2026.
• Market entry timing: Early entry in emerging markets could secure first-mover advantages.
• Pricing strategies: Influence margins, especially post-patent expiry.
• Development pipeline: Potential for expanded indications, including prophylactic uses.

Summary of Investment Outlook

Tafenoquine succinate offers a niche but potentially lucrative opportunity in antimalarial therapy. Its early market entry, strong regulatory approvals, and differentiated profile position it favorably for growth. However, patent expiry risks and competitive pressures require strategic planning.

Key Takeaways

• Significant market with growing demand for radical cure therapies.
• Patent expiration around 2024–2026 poses long-term profitability challenges.
• Pricing strategies and market penetration are critical for revenues.
• Competition and generics may erode margins post-patent expiry.
• Expanded indications could unlock future growth.

FAQs

1. What is the primary advantage of tafenoquine over primaquine?

It requires a single dose for radical cure, improving patient compliance and reducing adverse events related to multiple dosing.

2. When is patent expiration expected to occur?

Around 2024–2026, depending on jurisdiction and patent extensions.

3. What are the main regulatory hurdles for global expansion?

Obtaining approvals in emerging markets and navigating local registration processes.

4. How does the pricing compare to existing therapies?

In the U.S., retail prices are USD 1,200–1,500 per dose, higher than primaquine's cost, justified by reduced dosing complexity.

5. What are the major risks for investors?

Patent expiration, regulatory delays, market penetration barriers, and generic competition.

References

[1] MarketWatch. (2022). Malaria treatment market forecast 2021–2026.

[2] WHO. (2021). Malaria clinical guidelines and drug indications.