Viewing data from:

TEKTURNA

NDA

ALISKIREN HEMIFUMARATE | N021985 | LXO IRELAND DESIGNATED ACTIVITY CO

2 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Expired (1)TodayPED (+6 mo)

Today

8617595

Aug. 19, 2026

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

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 Tekturna (2023)

Total Spending

$1.1M

Total Claims

1,580

Beneficiaries

343

Avg Cost/Unit

$11.15

Spending Trend

$11.9M(2019)→$2.4M(2020)→$1.6M(2021)→$1.2M(2022)→$1.1M(2023)

YoY Change:+8.4%

5yr CAGR:+8.9%

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

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

18 letters from Drugs@FDA

Date	Submission	Document
Jun 19, 2020	SUPPL -39	View Letter (PDF)
Nov 15, 2017	SUPPL -34	View Letter (PDF)
Nov 18, 2016	SUPPL -31	View Letter (PDF)
Dec 23, 2015	SUPPL -28	View Letter (PDF)
Apr 1, 2015	SUPPL -27	View Letter (PDF)
Nov 7, 2013	SUPPL -25	View Letter (PDF)
Oct 2, 2012	SUPPL -24	View Letter (PDF)
Apr 18, 2012	SUPPL -23	View Letter (PDF)
Feb 7, 2012	SUPPL -22	View Letter (PDF)
Jan 31, 2012	SUPPL -21	View Letter (PDF)
Oct 17, 2011	SUPPL -19	View Letter (PDF)
Feb 14, 2011	SUPPL -14	View Letter (PDF)
Aug 10, 2010	SUPPL -12	View Letter (PDF)
Jan 25, 2010	SUPPL -8	View Letter (PDF)
May 21, 2008	SUPPL -6	View Letter (PDF)
Feb 20, 2008	SUPPL -4	View Letter (PDF)
Aug 14, 2007	SUPPL -2	View Letter (PDF)
Mar 15, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 150MG BASE

RLDAB

1 patent0 exclusivities▴

TABLET;ORAL | Approved: Mar 5, 2007

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8617595	Feb 19, 2026PED: Aug 19, 2026	PED	—	Yes	—	—

#002 — EQ 300MG BASE

RLDAB

1 patent0 exclusivities▾

TABLET;ORAL | Approved: Mar 5, 2007