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Last Updated: September 30, 2022

ARAKODA Drug Patent Profile


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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 two patents protecting this drug.

This drug has eight patent family members in seven countries.

The generic ingredient in ARAKODA is tafenoquine succinate. One supplier is 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

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Summary for ARAKODA
International Patents:8
US Patents:2
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 27
Clinical Trials: 3
Patent Applications: 402
Drug Prices: Drug price information for ARAKODA
What excipients (inactive ingredients) are in ARAKODA?ARAKODA excipients list
DailyMed Link:ARAKODA at DailyMed
Drug patent expirations by year for ARAKODA
Drug Prices for ARAKODA

See drug prices for ARAKODA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for ARAKODA
Generic Entry Date for ARAKODA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Naval Environmental Preventive Medicine Unit TWO (NEPMU-2)Phase 4
The 108 Military Central HospitalPhase 4
Australian Defence Force Malaria and Infectious Disease Institute (ADF MIDI)Phase 4

See all ARAKODA clinical trials

US Patents and Regulatory Information for ARAKODA

ARAKODA is protected by two US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ARAKODA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Patents protecting ARAKODA

Regimens of tafenoquine for prevention of malaria in malaria-naive subjects
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE ORAL PREVENTION/PROPHYLAXIS OF MALARIA IN ADULTS, COMPRISING A THREE-PHASE DOSING REGIMEN CONSISTING OF A LOADING/INITIAL DOSE, A MAINTENANCE/EXPOSURE DOSE, AND A TERMINAL/POST-EXPOSURE DOSE

Regimens of tafenoquine for prevention of malaria in malaria-naive subjects
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE ORAL PREVENTION/PROPHYLAXIS OF MALARIA IN ADULTS, COMPRISING A THREE-PHASE DOSING REGIMEN CONSISTING OF A LOADING/INITIAL DOSE, A MAINTENANCE/EXPOSURE DOSE, AND A TERMINAL/POST-EXPOSURE DOSE

FDA Regulatory Exclusivity protecting ARAKODA

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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

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

Patent: 15358566
Estimated Expiration: See Plans and Pricing

Patent: 20270452
Estimated Expiration: See Plans and Pricing

Canada

Patent: 68694
Estimated Expiration: See Plans and Pricing

China

Patent: 7683278
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 12621
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 43704
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201704154Q
Estimated Expiration: See Plans and Pricing

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
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) See Plans and Pricing
Singapore 11201704154Q NOVEL REGIMENS OF TAFENOQUINE FOR PREVENTION OF MALARIA IN MALARIA-NAÏVE SUBJECTS See Plans and Pricing
Australia 2015358566 Novel regimens of tafenoquine for prevention of malaria in malaria-naive subjects See Plans and Pricing
World Intellectual Property Organization (WIPO) 2016089995 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.