Viewing data from:

KRINTAFEL

NDA

TAFENOQUINE SUCCINATE | N210795 | GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LTD ENGLAND

1 strength0 unique patents0 unique exclusivities

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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Krintafel (2023)

Total Spending

$3K

Total Claims

Beneficiaries

Avg Cost/Unit

$17.63

Spending Trend

$945.44(2019)→$2K(2021)→$7K(2022)→$3K(2023)

YoY Change:+4.9%

5yr CAGR:-2.7%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

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

2 letters from Drugs@FDA

Date	Submission	Document
Nov 17, 2020	SUPPL -1	View Letter (PDF)
Jul 23, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 150MG BASE

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 20, 2018

No patent or exclusivity listings for this strength.