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Last Updated: June 17, 2024

Tafenoquine succinate - Generic Drug Details


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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 eight patent family members in seven countries.

Two suppliers are listed for this compound.

Summary for tafenoquine succinate
International Patents:8
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
Generic Entry Dates for tafenoquine succinate*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL
Generic Entry Dates for tafenoquine succinate*:
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.

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 ⤷  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
Glaxosmithkline KRINTAFEL tafenoquine succinate TABLET;ORAL 210795-001 Jul 20, 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 tafenoquine succinate

Country Patent Number Title Estimated Expiration
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
Australia 2020270452 Novel regimens of tafenoquine for prevention of malaria in malaria-naïve subjects ⤷  Sign Up
Australia 2015358566 Novel regimens of tafenoquine for prevention of malaria in malaria-naive subjects ⤷  Sign Up
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) ⤷  Sign Up
>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.