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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 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

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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:	383
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

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

Generic Entry Date for ARAKODA^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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
Australian Defence Force Malaria and Infectious Disease Institute (ADF MIDI)	Phase 4
Naval Medical Research Unit TWO (NAMRU-2)	Phase 4
Naval Medical Research Center	Phase 4

See all ARAKODA clinical trials

US Patents and Regulatory Information for ARAKODA

ARAKODA is protected by three US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ARAKODA is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
60 Degrees Pharms	ARAKODA	tafenoquine succinate	TABLET;ORAL	210607-001	Aug 8, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
60 Degrees Pharms	ARAKODA	tafenoquine succinate	TABLET;ORAL	210607-001	Aug 8, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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
Patent: Novel regimens of tafenoquine for prevention of malaria in malaria-naive subjects
Estimated Expiration: ⤷ Sign Up

Patent: 20270452
Patent: Novel regimens of tafenoquine for prevention of malaria in malaria-naïve subjects
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 68694
Patent: 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)
Estimated Expiration: ⤷ Sign Up

China

Patent: 7683278
Patent: 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)
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 12621
Patent: NOUVEAUX PROTOCOLES DE TRAITEMENT À BASE DE TAFÉNOQUINE POUR LA PRÉVENTION DU PALUDISME CHEZ DES PERSONNES NON-ATTEINTES DU PALUDISME (NOVEL REGIMENS OF TAFENOQUINE FOR PREVENTION OF MALARIA IN MALARIA-NAÏVE SUBJECTS)
Estimated Expiration: ⤷ Sign Up

Hong Kong

Patent: 43704
Patent: 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)
Estimated Expiration: ⤷ Sign Up

Singapore

Patent: 201704154Q
Patent: NOVEL REGIMENS OF TAFENOQUINE FOR PREVENTION OF MALARIA IN MALARIA-NAÏVE SUBJECTS
Estimated Expiration: ⤷ Sign Up

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.

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Country	Patent Number	Title	Estimated Expiration
Australia	2015358566	Novel regimens of tafenoquine for prevention of malaria in malaria-naive subjects	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2016089995		⤷ Sign Up
European Patent Office	3212621	NOUVEAUX PROTOCOLES DE TRAITEMENT À BASE DE TAFÉNOQUINE POUR LA PRÉVENTION DU PALUDISME CHEZ DES PERSONNES NON-ATTEINTES DU PALUDISME (NOVEL REGIMENS OF TAFENOQUINE FOR PREVENTION OF MALARIA IN MALARIA-NAÏVE SUBJECTS)	⤷ Sign Up
Singapore	11201704154Q	NOVEL REGIMENS OF TAFENOQUINE FOR PREVENTION OF MALARIA IN MALARIA-NAÏVE SUBJECTS	⤷ Sign Up
Australia	2020270452	Novel regimens of tafenoquine for prevention of malaria in malaria-naïve subjects	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration