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DYRENIUM

NDA

TRIAMTERENE | N013174 | ADVANZ PHARMA (US) CORP

2 strengths0 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

4 trials from ClinicalTrials.gov, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Action to Control Cardiovascular Risk in Diabetes (ACCORD)NCT00000620	Phase 3	Completed	National Heart, Lung, and Blood Institute (NHLBI)	10,251	1999-09 → 2012-12
Diuretics, Hypertension, and Arrhythmias Clinical Trial NCT00000525	Phase 3	Completed	University of California, San Francisco	233	1986-07
Increased Activity of a Renal Salt Transporter (ENaC) in Diabetic Kidney Disease NCT01918488	N/A	UNKNOWN	University of Southern Denmark	80	2013-10
A Crossover Pilot Study of the Effect of Amiloride on Proteinuria NCT02522650	Phase 4	UNKNOWN	Georgetown University	30	2013-07 → 2021-10

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

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

Highest NADAC/Unit

$7.04

per ea

Lowest NADAC/Unit

$6.28

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
66993083202TRIAMTERENE 100 MG CAPSULE	$7.04	EA	Generic	—	2026-06-17
66993083102TRIAMTERENE 50 MG CAPSULE	$6.28	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 | 8 NDCs (4 FSS, 4 Big4)

Lowest Price

$265.79

Highest Price

$1364.17

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
59212-0002-01DYRENIUM 50MG CAP	$1364.17	FSS	Amdipharm Limited	09/28/2026
59212-0002-01DYRENIUM 50MG CAP	$1104.78	Big4	Amdipharm Limited	09/28/2026
59212-0003-01DYRENIUM 100MG CAP	$1364.17	FSS	Amdipharm Limited	09/28/2026
59212-0003-01DYRENIUM 100MG CAP	$1105.08	Big4	Amdipharm Limited	09/28/2026
66993-0831-02TRIAMTERENE 50MG CAP	$870.65	FSS	Prasco, LLC	06/30/2026
66993-0831-02TRIAMTERENE 50MG CAP	$304.17	Big4	Prasco, LLC	06/30/2026
66993-0832-02TRIAMTERENE 100MG CAP	$870.65	FSS	Prasco, LLC	06/30/2026
66993-0832-02TRIAMTERENE 100MG CAP	$265.79	Big4	Prasco, LLC	06/30/2026

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

Medicare Part D Spending

CMS annual spending data for Dyrenium (2024)

Total Spending

$262K

Total Claims

229

Beneficiaries

Avg Cost/Unit

$13.40

Spending Trend

$3.0M(2019)→$797K(2020)→$478K(2021)→$323K(2022)→$283K(2023)→$262K(2024)

YoY Change:+5.5%

5yr CAGR:+5.3%

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

API Supply Chain3 active DMFs13 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

DIPHARMA FRANCIS SRLTRIAMTERENE USP

DMF 35161979

MOEHS IBERICA SLTRIAMTERENE

DMF 66031986

IPCA LABORATORIES LTDTRIAMTERENE USP

DMF 249652011

LEDERLE LABORATORIES DIV AMERICAN CYANAMID COInactiveTRIAMTERENE

DMF 6001963

LONZA RIVERSIDEInactiveTRIAMTERENE, USP

DMF 25861975

SCHARPER SPAInactiveTRIAMTERENE

DMF 32771978

SIEGFRIED AGInactiveTRIAMTERENE

DMF 33181978

ACIC LTDInactiveTRIAMTERENE USP

DMF 34161979

GANES CHEMICALS INC PENNSVILLE DIVInactiveTRIAMTERENE, BULK FORM

DMF 35251979

ROUSSELL UCLAFInactiveTRIAMTERENE

DMF 37871980

FARCHEMIA SRLInactiveTRIAMTERENE, USP

DMF 38061980

PLANTEX LTD CHEMICAL AND PHARMACEUTICAL WORKSInactiveTRIAMTERENE U.S.P.

DMF 43631981

SANOFI CHIMIEInactiveTRIAMTERENE

DMF 46771982

SELOC AGInactiveTRIAMTERENE USP XX

DMF 55531984

FABBRICA ITALIANA SINTETICI SPAInactiveTRIAMTERENE

DMF 73441988

MOEHS IBERICA SLInactiveTRIAMTERENE

DMF 187572005

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

Products (2)

Sort:

#001 — 50MG

RLDAB

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 100MG

RLDAB

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982