tafenoquine succinate · 60 Degrees Pharms · NDA 210607

Arakoda

Earliest generic entry, as listed
2 Dec 2035

Blocked by patent: US 10342791, US 10888558, US 11744828, US 12616689. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 4 unexpired

PatentClaimsExpires
US 10342791use U-2582 · sets the listed date2 Dec 2035
US 10888558use U-2582 · sets the listed date2 Dec 2035
US 11744828use U-2582 · sets the listed date2 Dec 2035
US 12616689use U-2582 · sets the listed date2 Dec 2035

Exclusivities · 0 unexpired

No unexpired exclusivities listed.

Paragraph IV certifications · 0

No Paragraph IV certification listed by FDA for this drug.

The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.

Event history

No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.

Products covered · 1

NDA · productFormStrengthListed expiry
210607 · 001 · RLDtablet, oralEQ 100MG BASE2 Dec 2035