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TEKTURNA

NDA

ALISKIREN HEMIFUMARATE | N210709 | NODEN PHARMA DAC

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

API Supply Chain2 active DMFs2 inactive

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

MSN LABORATORIES PRIVATE LTDALISKIREN HEMIFUMARATE [ROUTE CODE - "AF"]

DMF 269752013

JUBILANT PHARMOVA LTDALISKIREN HEMIFUMARATE

DMF 280502014

CHANGZHOU PHARMACEUTICAL FACTORYInactiveALISKIREN HEMIFUMARATE

DMF 247552011

CHEMO IBERICA SAInactiveALISKIREN HEMIFUMARATE

DMF 267762012

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Nov 15, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 37.5MG BASE

RLD

0 patents0 exclusivities▴

CAPSULE, PELLET;ORAL | Approved: Nov 14, 2017

No patent or exclusivity listings for this strength.