Tafenoquine succinate - Generic Drug Details

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.

Two suppliers are listed for this compound.

Summary for tafenoquine succinate

International Patents:	9
US Patents:	3
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	44
Patent Applications:	49
What excipients (inactive ingredients) are in tafenoquine succinate?	tafenoquine succinate excipients list
DailyMed Link:	tafenoquine succinate at DailyMed

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

Constraining patent/regulatory exclusivity:

10,888,558

Dosage:

TABLET;ORAL

Constraining patent/regulatory exclusivity:

INDICATED FOR THE RADICAL CURE (PREVENTION OF RELAPSE) OF PLASMODIUM VIVAX MALARIA IN PATIENTS AGED 16 YEARS AND OLDER WHO ARE RECEIVING APPROPRIATE ANTIMALARIAL THERAPY FOR ACUTE P. VIVAX INFECTION

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.

Anatomical Therapeutic Chemical (ATC) Classes for tafenoquine succinate

P01BA	Aminoquinolines
P01B	ANTIMALARIALS
P01	ANTIPROTOZOALS
P	Antiparasitic products, insecticides and repellents

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
Glaxosmithkline	KRINTAFEL	tafenoquine succinate	TABLET;ORAL	210795-001	Jul 20, 2018		RX	Yes	Yes
60 Degrees Pharms	ARAKODA	tafenoquine succinate	TABLET;ORAL	210607-001	Aug 8, 2018		RX	Yes	Yes	11,744,828
60 Degrees Pharms	ARAKODA	tafenoquine succinate	TABLET;ORAL	210607-001	Aug 8, 2018		RX	Yes	Yes	10,888,558

International Patents for tafenoquine succinate

Country	Patent Number	Title	Estimated Expiration
Canada	2968694	REGIMES A BASE DE TAFENOQUINE POUR LA PREVENTION DU PALUDISME CHEZ DES PERSONNES NON ATTEINTES DU PALUDISME (REGIMENS OF TAFENOQUINE FOR PREVENTION OF MALARIA IN MALARIA-NAIVE SUBJECTS)
Hong Kong	1243704	用於在未接觸瘧疾的受試者中預防瘧疾的他非諾喹的新方案 (NOVEL REGIMENS OF TAFENOQUINE FOR PREVENTION OF MALARIA IN MALARIA-NAÏVE SUBJECTS)
China	107683278	用于在未接触疟疾的受试者中预防疟疾的他非诺喹的新方案 (Novel Regimens Of Tafenoquine For Prevention Of Malaria In Malaria-Na Ve Subjects)

Market Dynamics and Financial Trajectory for Tafenoquine Succinate

Introduction to Tafenoquine Succinate

Tafenoquine succinate, an 8-aminoquinoline derivative, has been a significant development in the fight against malaria, particularly for the radical cure of Plasmodium vivax (Pv) malaria. Here, we delve into the market dynamics and financial trajectory of this drug.

Development and Partnerships

Tafenoquine was first synthesized by scientists at the Walter Reed Army Institute of Research in 1978. The development of tafenoquine as an anti-relapse medicine for Pv malaria has been a collaborative effort, notably between GlaxoSmithKline (GSK) and the Medicines for Malaria Venture (MMV)[3].

Regulatory Approvals

Tafenoquine has received regulatory approvals in several countries, including the United States, Australia, Brazil, Ethiopia, Guyana, Peru, Thailand, Colombia, and the Philippines. These approvals are crucial for its market entry and expansion[3].

Market Launch and Expansion

The launch of tafenoquine in Brazil and Thailand marks a significant milestone, as these are the first malaria-endemic countries to introduce this single-dose radical cure medicine. This launch is part of the global efforts to eliminate malaria, supported by partnerships between GSK, MMV, and other health organizations[3].

Market Demand and Need

Plasmodium vivax malaria is a major public health issue in many regions outside of sub-Saharan Africa. The disease is characterized by clinical relapses, which impose a substantial physical, economic, and social burden on patients and communities. The demand for effective treatments is high, especially in areas like the Yanomami Special Indigenous Health District in Brazil, where Pv malaria accounts for nearly 70% of all malaria cases[3].

Competitive Landscape

Tafenoquine enters a market where other antimalarial drugs like chloroquine, mefloquine, and primaquine are already established. However, its unique advantage as a single-dose radical cure for Pv malaria sets it apart. The drug's efficacy against all stages of the Pv lifecycle, including hypnozoites, makes it a valuable addition to the antimalarial arsenal[3].

Pricing and Accessibility

The pricing of tafenoquine is a critical factor in its market dynamics. While specific pricing details are not widely available, the collaboration with MMV and other health organizations aims to ensure the drug is accessible to those who need it most, particularly in low-income and malaria-endemic countries[3].

Financial Trajectory

Development Costs and Funding

The development of tafenoquine has been supported by significant investments from GSK, MMV, and other partners. These costs include research, clinical trials, and regulatory approvals. The orphan drug designation for tafenoquine, particularly for babesiosis, also provides financial incentives to encourage its development[2].

Revenue Projections

Given the high demand for effective Pv malaria treatments, tafenoquine is expected to generate substantial revenue. The drug's approval and launch in multiple countries will expand its market reach. However, exact revenue projections are not publicly disclosed, but the drug's potential impact on public health suggests a strong financial outlook.

Market Size and Growth

The global antimalarial market is expected to grow, driven by increasing efforts to eliminate malaria. Tafenoquine's unique position as a single-dose radical cure for Pv malaria positions it for significant market share. The market size for antimalarial drugs is substantial, and tafenoquine's entry is expected to capture a notable portion of this market[3].

Challenges and Opportunities

Safety and Efficacy Concerns

Tafenoquine has shown potential safety signals, including neurologic, psychiatric, and hematologic adverse events. These concerns need to be managed through careful patient selection and monitoring, particularly for those with glucose-6-phosphate dehydrogenase (G6PD) deficiency[4].

Regulatory and Market Access

Securing regulatory approvals in additional countries is crucial for expanding the market. The ongoing evaluations in various countries indicate a positive trajectory for broader market access.

Public Health Impact

The successful rollout of tafenoquine in Brazil and Thailand highlights its potential to significantly impact public health. Reducing the burden of Pv malaria can lead to economic and social benefits, further driving demand and adoption of the drug.

Future Developments and Trials

Tafenoquine is also being explored for other indications, including babesiosis and COVID-19 infections. Upcoming trials, such as the phase II trial for babesiosis planned by 60 Degrees Pharmaceuticals, will further define its market potential[2].

Key Takeaways

• Regulatory Approvals: Tafenoquine has received approvals in multiple countries, facilitating its market entry.
• Market Demand: High demand for effective Pv malaria treatments drives the market dynamics.
• Competitive Advantage: Single-dose radical cure for Pv malaria sets tafenoquine apart from existing treatments.
• Financial Outlook: Significant revenue potential due to its unique position and growing market.
• Challenges: Safety concerns and regulatory hurdles need careful management.

FAQs

What is tafenoquine succinate used for?

Tafenoquine succinate is used for the radical cure (prevention of relapse) of Plasmodium vivax malaria in patients aged 16 years and older[1].

Who are the key developers of tafenoquine?

The key developers include GlaxoSmithKline (GSK), Medicines for Malaria Venture (MMV), and 60 Degrees Pharmaceuticals[2][3].

What are the safety concerns associated with tafenoquine?

Tafenoquine has potential safety signals including neurologic, psychiatric, and hematologic adverse events, particularly in patients with G6PD deficiency[4].

In which countries is tafenoquine approved?

Tafenoquine is approved in the US, Australia, Brazil, Ethiopia, Guyana, Peru, Thailand, Colombia, and the Philippines[3].

What is the unique advantage of tafenoquine over other antimalarial drugs?

Tafenoquine offers a single-dose radical cure for Pv malaria, effective against all stages of the Pv lifecycle, including hypnozoites[3].

Cited Sources

1. Australian Public Assessment Report for Tafenoquine (as succinate) - Therapeutic Goods Administration, November 2018.
2. Tafenoquine - GlaxoSmithKline/60 Degrees Pharmaceuticals - AdisInsight, Springer.
3. Brazil and Thailand become first malaria-endemic countries to launch new single-dose radical cure medicine - GSK, July 2024.
4. FDA NDA 210607 for Tafenoquine Succinate Tablet - FDA, August 2018.