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:
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.
Anatomical Therapeutic Chemical (ATC) Classes for tafenoquine succinate
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 |
|---|---|---|---|
| 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 |
| >Country | >Patent Number | >Title | >Estimated Expiration |
