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ARAKODA

NDA

TAFENOQUINE SUCCINATE | N210607 | 60 DEGREES PHARMACEUTICALS INC

1 strength4 unique patents0 unique exclusivities

Patent Timeline

4 unique patents by expiration date

Active (4)Today

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Dec. 2, 2035

Dec. 2, 2035

Dec. 2, 2035

Dec. 2, 2035

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

15 trials from ClinicalTrials.gov, 14 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Randomized, Double-blind, Placebo-controlled Evaluation of Increasing Doses of Weekly Tafenoquine for Chemosuppression of Plasmodium Falciparum NCT02488902	Phase 2	Completed	U.S. Army Medical Research and Development Command	521	1998-08 → 2003-03
G6PD (Glucose-6-phosphate Dehydrogenase) Study to Evaluate Hemolysis Potential of TFQ (Tafenoquine)NCT01205178	Phase 1	Completed	GlaxoSmithKline	192	2009-07-02 → 2013-04-01
Efficacy and Safety Study of Tafenoquine (TQ) Co-administered With Dihydroartemisinin-piperaquine (DHA-PQP) for the Radical Cure of Plasmodium Vivax (P. Vivax) Malaria NCT02802501	Phase 3	Completed	GlaxoSmithKline	150	2018-04-08 → 2019-08-19
A Pharmacokinetics, Safety and Efficacy Study of Tafenoquine (TQ) in Pediatric Subjects With Plasmodium Vivax (P. Vivax) Malaria NCT02563496	Phase 2	Completed	GlaxoSmithKline	60	2017-02-06 → 2020-02-17
A Study to Assess the Effects of Dissolution Profile on the Pharmacokinetics of Single Oral Doses of Tafenoquine Tablets and Tafenoquine Stable Isotope Labelled Solution NCT02751294	Phase 1	Completed	GlaxoSmithKline	14	2016-05 → 2016-08
Long-Term Safety Study of Tafenoquine NCT03320174	Phase 2	Completed	60 Degrees Pharmaceuticals LLC	600	2017-10-05 → 2021-07-13
Evaluation of Weekly Tafenoquine NCT02491606	Phase 2	Completed	U.S. Army Medical Research and Development Command	249	1997-05 → 1998-09
Study to Assess the Incidence of Hemolysis, Safety, and Efficacy of Tafenoquine (SB-252263, WR238605) Versus Primaquine in Subjects With Plasmodium Vivax Malaria NCT02216123	Phase 3	Completed	GlaxoSmithKline	251	2015-04-30 → 2016-11-04
Assessment of Any Potential Retinal Effects of Tafenoquine (TQ)NCT02658435	Phase 1	Completed	GlaxoSmithKline	486	2016-02-02 → 2017-09-14
An Evaluation of Weekly Tafenoquine NCT02488980	Phase 2	Completed	U.S. Army Medical Research and Development Command	306	2000-05 → 2003-03

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (2 FSS)

Lowest Price

$97.31

Highest Price

$177.44

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
71475-0257-01ARAKODA 100MG TAB	$177.44	FSS	60 Degrees Pharmaceuticals, Inc.	08/01/2026
71475-0257-02ARAKODA 100MG TAB	$97.31	FSS	60 Degrees Pharmaceuticals, Inc.	08/01/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

MSN LIFE SCIENCES PRIVATE LTDTAFENOQUINE SUCCINATE

DMF 351612020

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 10, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 100MG BASE

RLD

4 patents0 exclusivities▴

TABLET;ORAL | Approved: Aug 8, 2018

Patents (4) · 4 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
10342791	Dec 2, 2035	—	—	—	—
10888558	Dec 2, 2035	—	—	—	—
11744828	Dec 2, 2035	—	—	—	—
12616689	Dec 2, 2035	—	—	—	—