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
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: | 419 |
| Drug Prices: | Drug price information for ARAKODA |
| What excipients (inactive ingredients) are in ARAKODA? | ARAKODA excipients list |
| DailyMed Link: | ARAKODA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
| Sponsor | Phase |
|---|---|
| The 108 Military Central Hospital | Phase 4 |
| Australian Defence Force Malaria and Infectious Disease Institute (ADF MIDI) | Phase 4 |
| Naval Medical Research Unit TWO (NAMRU-2) | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for ARAKODA
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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| 60 Degrees Pharms | ARAKODA | tafenoquine succinate | TABLET;ORAL | 210607-001 | Aug 8, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| 60 Degrees Pharms | ARAKODA | tafenoquine succinate | TABLET;ORAL | 210607-001 | Aug 8, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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: ⤷ Try a Trial
Patent: 20270452
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 68694
Estimated Expiration: ⤷ Try a Trial
China
Patent: 7683278
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 12621
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 43704
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 201704154Q
Estimated Expiration: ⤷ Try a Trial
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 |
|---|---|---|---|
| Australia | 2020270452 | Novel regimens of tafenoquine for prevention of malaria in malaria-naïve subjects | ⤷ Try a Trial |
| 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) | ⤷ Try a Trial |
| World Intellectual Property Organization (WIPO) | 2016089995 | ⤷ Try a Trial | |
| 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) | ⤷ Try a Trial |
| 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) | ⤷ Try a Trial |
| Australia | 2015358566 | Novel regimens of tafenoquine for prevention of malaria in malaria-naive subjects | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
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