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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Noden Pharma DAC v. Anchen Pharmaceuticals, Inc. et al 1:2017cv00728	D. Del.	2017-06-12	Terminated 2018-06-12	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs (1 brand, 2 generic)

Highest NADAC/Unit

$15.09

per ea

Lowest NADAC/Unit

$4.10

per ea

Brand NDCs

Generic NDCs

Avg Brand: $15.09

Avg Generic: $4.89

68% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
70839030030TEKTURNA 300 MG TABLET	$15.09	EA	Brand	$5.68	2026-01-06
66993014230ALISKIREN 300 MG TABLET	$5.68	EA	Generic	—	2026-06-17
66993014130ALISKIREN 150 MG TABLET	$4.10	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (4 FSS, 2 Big4)

Lowest Price

$74.05

Highest Price

$180.47

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
66993-0141-30ALISKIREN 150MG TAB	$133.72	FSS	Prasco, LLC	06/30/2026
66993-0141-30ALISKIREN 150MG TAB	$74.05	Big4	Prasco, LLC	06/30/2026
66993-0142-30ALISKIREN 300MG TAB	$169.52	FSS	Prasco, LLC	06/30/2026
66993-0142-30ALISKIREN 300MG TAB	$95.35	Big4	Prasco, LLC	06/30/2026
70839-0300-30TEKTURNA 300MG TAB	$180.47	FSS	LXO US, Inc.	05/14/2030
70839-0150-30TEKTURNA 150MG TAB	$143.06	FSS	LXO US, Inc.	05/14/2030

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Tekturna (2024)

Total Spending

$868K

Total Claims

1,180

Beneficiaries

262

Avg Cost/Unit

$11.32

Spending Trend

$11.9M(2019)→$2.4M(2020)→$1.6M(2021)→$1.2M(2022)→$1.1M(2023)→$868K(2024)

YoY Change:+1.6%

5yr CAGR:+8.2%

Source: CMS Medicare Part D Spending by Drug (2024). 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 BIOSYS 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