Details for New Drug Application (NDA): 210607
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NDA 210607 describes ARAKODA, which is a drug marketed by 60 Degrees Pharms and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the ARAKODA profile page.
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.
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.
Summary for 210607
| Tradename: | ARAKODA |
| Applicant: | 60 Degrees Pharms |
| Ingredient: | tafenoquine succinate |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210607
Generic Entry Date for 210607*:
Constraining patent/regulatory exclusivity:
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.
Suppliers and Packaging for NDA: 210607
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ARAKODA | tafenoquine succinate | TABLET;ORAL | 210607 | NDA | 60 Degrees Pharmaceuticals, LLC | 71475-257 | 71475-257-01 | 2 BLISTER PACK in 1 CARTON (71475-257-01) / 8 TABLET, FILM COATED in 1 BLISTER PACK |
| ARAKODA | tafenoquine succinate | TABLET;ORAL | 210607 | NDA | 60 Degrees Pharmaceuticals, LLC | 71475-257 | 71475-257-02 | 8 TABLET, FILM COATED in 1 BOTTLE (71475-257-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Aug 8, 2018 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jul 20, 2023 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Dec 2, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
| 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: | ⤷ Try a Trial | Patent Expiration: | Dec 2, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
| 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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