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FDA Orange Book · active-ingredient family

Tafenoquine succinate

Tafenoquine succinate is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:ARAKODA · NDA 210607

2

Brand (NDA)

0

Generics (ANDA)

4

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
ARAKODARLD60 DEGREES PHARMSNDA 210607Aug 08, 2018
KRINTAFELRLDGLAXOSMITHKLINENDA 210795Jul 20, 2018

Listed patents (4)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10342791Dec 02, 2035in 9 yr 7 mo
U-2582
11744828Dec 02, 2035in 9 yr 7 mo
U-2582
10888558Dec 02, 2035in 9 yr 7 mo
U-2582
12616689Dec 02, 2035in 9 yr 7 mo
U-2582

Tafenoquine succinate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.