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 | ⤷ 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 | ||||
| Glaxosmithkline | KRINTAFEL | tafenoquine succinate | TABLET;ORAL | 210795-001 | Jul 20, 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 tafenoquine succinate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2016089995 | ⤷ Try a Trial | |
| Australia | 2015358566 | Novel regimens of tafenoquine for prevention of malaria in malaria-naive subjects | ⤷ Try a Trial |
| 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 |
| 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 |
| >Country | >Patent Number | >Title | >Estimated Expiration |
