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TRIBENZOR

NDA

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | N200175 | COSETTE PHARMACEUTICALS INC

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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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$19.54

per ea

Lowest NADAC/Unit

$19.41

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00713087530TRIBENZOR 40-5-12.5 MG TABLET	$19.54	EA	Brand	$1.22	2026-07-01
00713087830TRIBENZOR 40-10-25 MG TABLET	$19.41	EA	Brand	$1.17	2026-07-01

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

VA Federal Supply Schedule

Government-negotiated contract prices | 5 NDCs (5 FSS)

Lowest Price

$191.29

Highest Price

$297.20

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00713-0875-30TRIBENZOR 40/5/12.5 TABLETS	$231.63	FSS	Cosette Pharmaceutical, Inc.	08/14/2027
00713-0876-30TRIBENZOR 40/5/25 MG TABLETS	$297.20	FSS	Cosette Pharmaceutical, Inc.	08/14/2027
00713-0877-30TRIBENZOR 40/10/12.5 MG TABLETS	$191.29	FSS	Cosette Pharmaceutical, Inc.	08/14/2027
00713-0874-30TRIBENZOR 20/5/12.5 TABLETS	$236.53	FSS	Cosette Pharmaceutical, Inc.	08/14/2027
00713-0878-30TRIBENZOR 40/10/25 MG TABLETS	$295.19	FSS	Cosette Pharmaceutical, Inc.	08/14/2027

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

Medicare Part D Spending

CMS annual spending data for Tribenzor (2024)

Total Spending

$1.5M

Total Claims

2,198

Beneficiaries

423

Avg Cost/Unit

$14.19

Spending Trend

$2.7M(2019)→$2.5M(2020)→$2.2M(2021)→$292K(2022)→$1.8M(2023)→$1.5M(2024)

YoY Change:-1.0%

5yr CAGR:+1.6%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Approval Letters

15 letters from Drugs@FDA

Date	Submission	Document
Oct 5, 2020	SUPPL -33	View Letter (PDF)
Aug 21, 2020	SUPPL -37	View Letter (PDF)
Jan 13, 2017	SUPPL -26	View Letter (PDF)
Nov 2, 2016	SUPPL -25	View Letter (PDF)
Sep 24, 2014	SUPPL -20	View Letter (PDF)
Jun 30, 2014	SUPPL -19	View Letter (PDF)
Jun 18, 2014	SUPPL -18	View Letter (PDF)
Jul 5, 2013	SUPPL -15	View Letter (PDF)
Dec 11, 2012	SUPPL -12	View Letter (PDF)
Oct 3, 2012	SUPPL -11	View Letter (PDF)
Jan 23, 2012	SUPPL -8	View Letter (PDF)
Nov 3, 2011	SUPPL -7	View Letter (PDF)
Jun 27, 2011	SUPPL -3	View Letter (PDF)
Apr 6, 2011	SUPPL -1	View Letter (PDF)
Jul 28, 2010	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — EQ 5MG BASE;12.5MG;20MG

RLDAB

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