Details for Patent: 12,616,689
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Which drugs does patent 12,616,689 protect, and when does it expire?
Patent 12,616,689 protects ARAKODA and is included in one NDA.
This patent has nine patent family members in eight countries.
Summary for Patent: 12,616,689
| Title: | Regimens of tafenoquine for prevention of malaria in malaria-naive subjects |
| Abstract: | Methods of prevention of symptomatic malaria in a malaria-naïve, G6PD-normal human subject comprising administering to the human subject a compound of Formula (I), a pharmaceutically acceptable salt thereof, or pharmaceutical composition comprising a compound of Formula (I): A compound of Formula (I) can be administered prior to potential exposure of a species of Plasmodium, during potential exposure of a species of Plasmodium, and after potential exposure of a species of Plasmodium. The methods of the invention also pertains to kits comprising specific doses of Formula (I), a pharmaceutically acceptable salt thereof, or pharmaceutical composition comprising a compound of Formula (I), and instructions for administration of dosing quantity and frequency. The methods of the invention also pertain to determining doses of Formula (I) that meet the general regulatory requirement for a drug to be efficacious in the prevention of malaria in malaria-naïve subjects. The methods of the invention further pertain to using the described algorithm to derive dosing regimens which can provide protection against symptomatic malaria in malaria-naïve, G6PD-normal subjects. |
| Inventor(s): | Geoffrey S. DOW, Bryan L. Smith, John P. Jones, Moshe Shmuklarsky, Budda Balasubrahmanyam |
| Assignee: | 60 Degrees Pharmaceuticals Inc , United States Department of the Army |
| Application Number: | US18/240,049 |
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Patent Claim Types: see list of patent claims | Use; Composition; Delivery; |
Drugs Protected by US Patent 12,616,689
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 60 Degrees Pharms | ARAKODA | tafenoquine succinate | TABLET;ORAL | 210607-001 | Aug 8, 2018 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | 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 | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Patented / Exclusive Use | >Submissiondate |
International Family Members for US Patent 12,616,689
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Australia | 2015358566 | ⤷ Start Trial | |||
| Australia | 2020270452 | ⤷ Start Trial | |||
| Canada | 2968694 | ⤷ Start Trial | |||
| China | 107683278 | ⤷ Start Trial | |||
| European Patent Office | 3212621 | ⤷ Start Trial | |||
| Hong Kong | 1243704 | ⤷ Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
