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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 eight patent family members in seven 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:	8
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	3
Patent Applications:	439
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

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
Singapore	11201704154Q	NOVEL REGIMENS OF TAFENOQUINE FOR PREVENTION OF MALARIA IN MALARIA-NAÏVE SUBJECTS
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)
World Intellectual Property Organization (WIPO)	2016089995

ARAKODA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ARAKODA

Introduction to ARAKODA

ARAKODA®, developed by 60 Degrees Pharmaceuticals, is a significant player in the antimalarial market. It is the only FDA-approved prophylactic therapy that protects against all stages of malaria, offering a convenient weekly dosing schedule[2].

Market Positioning

ARAKODA is uniquely positioned due to its broad efficacy against all malaria stages and its CDC recommendation. This differentiation sets it apart from other antimalarial medications, making it a crucial option for travelers to malaria-endemic regions[2].

Revenue Growth

In recent quarters, 60 Degrees Pharmaceuticals has reported substantial revenue growth driven by ARAKODA sales. For the third quarter of 2024, the company saw a 164% year-over-year increase in sales revenue, reaching $135,000. This growth was fueled by a 140% increase in ARAKODA pharmacy deliveries from 550 boxes in Q3 2023 to 1,319 boxes in Q3 2024[1].

Quarterly Financial Highlights

• Q1 2024: ARAKODA sales revenue increased 515% year-over-year to $105.7 thousand, driven by an increased commercial batch size[4].
• Q2 2024: Net product revenues doubled year-over-year to $125,000, with a sequential quarter-over-quarter revenue growth of 18.3%. Gross profit improved from a loss of $124,000 to a gain of $35,000[3].
• Q3 2024: Revenue grew 164% year-over-year to $135,000, with a gross profit of $24,000 compared to a gross loss of $20,000 in Q3 2023[1].

Operational Expenses and Net Loss

Despite the revenue growth, the company has faced significant increases in operating expenses. In Q3 2024, operating expenses were approximately $2.16 million, up from $1.58 million in Q3 2023. This increase was partly due to the delivery of research materials previously paid for in stock. The net loss attributable to common shareholders in Q3 2024 was $2.27 million, or ($0.93) per share, largely due to changes in the fair value of liabilities[1].

Promotional and Sales Strategies

60 Degrees Pharmaceuticals has launched a nine-month promotional pilot for ARAKODA to increase brand awareness and utilization. This pilot includes virtual sales outreach and a co-pay assistance program to reduce out-of-pocket costs for consumers. The data collected from this pilot will inform future promotional efforts and help in assessing the potential market size and growth trajectory for ARAKODA[2].

Clinical Progress and Regulatory Milestones

The company has made significant clinical progress, including the initiation of a tafenoquine study for Babesiosis at Tufts Medical Center. The FDA granted Orphan Drug Designation for tafenoquine in acute babesiosis treatment, which could accelerate future growth and present a potential market opportunity[3].

Supply Chain and Contract Awards

60 Degrees Pharmaceuticals was awarded a contract with the U.S. Army to facilitate commercial validation of new packaging for ARAKODA. This contract and the increase in commercial batch size in Q1 2024 are indicative of the company's anticipation of increasing sales volume[4].

Leadership and Commercial Strategy

The appointment of Kristen Landon as Chief Commercial Officer has been a strategic move to lead the relaunch of ARAKODA for malaria prevention and expand its commercial reach. This leadership change underscores the company's commitment to enhancing its market presence[5].

Challenges and Risk Factors

Despite the positive trends, 60 Degrees Pharmaceuticals faces several challenges, including substantial doubt about its ability to continue as a going concern, potential eligibility issues for Australian government research and development tax rebates, and the lack of manufacturing capacity. These factors could impact the company's ability to expand its business operations and bring products to market in a timely manner[5].

Future Outlook

The success of the promotional pilot and the insights gained from it will be crucial for the company's future revenue and market position. The planned expanded U.S. sales effort in 2025, coupled with the unique positioning of ARAKODA, suggests potential for significant market growth. However, the company must navigate its operational challenges to achieve profitability[2].

Key Takeaways

• Revenue Growth: Significant year-over-year revenue growth driven by increased ARAKODA sales.
• Operational Expenses: High operating expenses impacting net loss.
• Clinical Progress: Advancements in clinical trials and regulatory milestones, including Orphan Drug Designation.
• Promotional Strategies: Ongoing promotional pilot to enhance brand awareness and utilization.
• Leadership: Strategic leadership changes to drive commercial success.
• Challenges: Substantial operational and financial challenges that need to be addressed.

FAQs

What is ARAKODA and its unique selling point?

ARAKODA is an FDA-approved prophylactic therapy that protects against all stages of malaria, offering a convenient weekly dosing schedule. It is the only medication with this broad efficacy against malaria.

How has ARAKODA's revenue performed in recent quarters?

ARAKODA has seen significant revenue growth, with a 164% year-over-year increase in Q3 2024, a 515% increase in Q1 2024, and a doubling of revenue in Q2 2024.

What is the purpose of the promotional pilot for ARAKODA?

The promotional pilot aims to increase brand awareness and utilization through virtual sales outreach and a co-pay assistance program, providing valuable data for future marketing efforts.

What are the key challenges facing 60 Degrees Pharmaceuticals?

The company faces challenges such as substantial doubt about its ability to continue as a going concern, potential issues with tax rebates, and the lack of manufacturing capacity.

How does the FDA Orphan Drug Designation impact ARAKODA?

The FDA Orphan Drug Designation for tafenoquine in acute babesiosis treatment could accelerate future growth and present a significant market opportunity for 60 Degrees Pharmaceuticals.

Cited Sources:

1. GlobeNewswire - 60 Degrees Pharmaceuticals Announces Third Quarter 2024 Results
2. StockTitan - 60 Degrees Pharmaceuticals Inc. Announces ARAKODA Promotional Pilot
3. StockTitan - 60 Degrees Pharmaceuticals Announces Second Quarter 2024 Results
4. Investors.60DegreesPharma - 60 Degrees Pharmaceuticals Awarded Contract with U.S. Army for ARAKODA Supply Chain Upgrade Support
5. GlobeNewswire - 60 Degrees Pharmaceuticals Appoints Kristen Landon as Chief Commercial Officer