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THALITONE

NDA

CHLORTHALIDONE | N019574 | CASPER PHARMA LLC

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Clinipace Worldwide FDA-2015-P-3299 · 7 docket documents Clinipace Worldwide filed this petition on behalf of a client requesting that the FDA determine whether THALITONE 15 mg (chlorthalidone tablets, NDA 019574), discontinued by Citron Pharma LLC, was withdrawn for reasons of safety or effectiveness, and if not, that the FDA accept an ANDA for a generic	505(q)	2015-09-11	Granted	Clinipace Worldwide

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

59 trials from ClinicalTrials.gov, 45 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Use of Impedance Cardiography and Applanation Tonometry for Prediction of the Antihypertensive Effect of Two Drugs NCT03560804	N/A	Completed	AHEPA University Hospital	60	2014-11-10 → 2017-09-15
Diuretics and Angiotensin-Receptor Blocker Agents in Patients With Stage I Hypertension NCT00971165	Phase 3	Completed	Hospital de Clinicas de Porto Alegre	655	2010-07 → 2014-09
A Safety and Tolerability Study of Azilsartan Medoxomil in Participants With Essential Hypertension NCT00696384	Phase 3	Completed	Takeda	418	2007-06 → 2009-04
Long-Term Safety of Azilsartan Medoxomil and Chlorthalidone Compared to Olmesartan Medoxomil and Hydrochlorothiazide in Participants With Hypertension and Kidney Disease NCT01309828	Phase 3	Completed	Takeda	153	2011-03 → 2012-10
Clinical Trial to Compare the Safety and Pharmacokinetics of YH22162 in Healthy Volunteers NCT03662620	Phase 1	Completed	Yuhan Corporation	67	2018-10-05 → 2018-12-22
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
Study to Evaluate the Effect on Improvement of LVH by the Control of BP in Hypertension Patients With AV Disease NCT03666351	Phase 4	Completed	Hanmi Pharmaceutical Company Limited	128	2018-10-18 → 2022-07-25
Thiazide Diuretics for Hypertension in Kidney Transplant Recipients Using Tacrolimus NCT02644395	Phase 3	Completed	Erasmus Medical Center	49	2013-01-18 → 2016-12-19
Treatment of Hypertension In Adults With ThiaZIDES: Pragmatic Trial Pilot Study NCT02591628	N/A	Completed	HealthPartners Institute	2,027	2015-08 → 2017-07
Efficacy and Safety of Azilsartan Medoxomil and Chlorthalidone in Participants With Moderate to Severe Hypertension NCT00818883	Phase 3	Completed	Takeda	609	2009-02 → 2009-11

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$3.54

per ea

Lowest NADAC/Unit

$3.54

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
70199001730THALITONE 15 MG TABLET	$3.54	EA	Brand	—	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 | 1 NDC (1 FSS)

Lowest Price

$83.04

Highest Price

$83.04

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
70199-0017-30THALITONE 15MG TAB	$83.04	FSS	Casper Pharma LLC	04/30/2027

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

Medicare Part D Spending

CMS annual spending data for Thalitone (2024)

Total Spending

$578K

Total Claims

3,517

Beneficiaries

1,493

Avg Cost/Unit

$3.56

Spending Trend

$13K(2021)→$312K(2022)→$538K(2023)→$578K(2024)

YoY Change:-5.9%

5yr CAGR:-2.6%

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

API Supply Chain15 active DMFs11 inactive

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

CURIA ITALY SRLCHLORTHALIDONE USP-EP

DMF 24381975

IPCA LABORATORIES LTDCHLORTHALIDONE USP

DMF 178082004

IPCA LABORATORIES LTDCHLORTHALIDONE USP (CT6 PROCESS)

DMF 275792013

AMOLI ORGANICS (A DIVISION OF UMEDICA LABORATORIES PVT LTD)CHLORTHALIDONE USP

DMF 305512016

UNICHEM LABORATORIES LTDCHLORTHALIDONE USP

DMF 320372017

MACLEODS PHARMACEUTICALS LTDCHLORTHALIDONE

DMF 322072017

MATRIX PHARMACORP PRIVATE LTDCHLORTHALIDONE USP

DMF 322912017

SOLARA ACTIVE PHARMA SCIENCES LTDCHLORTHALIDONE USP

DMF 324122018

MAITHRI DRUGS PRIVATE LTDCHLORTHALIDONE USP

DMF 326412018

CHROMO LABORATORIES INDIA PRIVATE LTDCHLORTHALIDONE USP

DMF 330712018

ZYDUS LIFESCIENCES LTDCHLORTHALIDONE USP

DMF 334322019

MENADIONA SLCHLORTHALIDONE

DMF 344092020

HONOUR LAB LTDCHLORTHALIDONE

DMF 352362021

CTX LIFESCIENCES PVT LTDCHLORTHALIDONE USP

DMF 391422023

MSN LIFE SCIENCES PRIVATE LTDCHLORTHALIDONE USP

DMF 405152024

INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPAInactiveCHLORTHALIDONE

DMF 28141976

FARCHEMIA SRLInactiveCHLORTHALIDONE

DMF 34451977

ACIC LTDInactiveCHLORTHALIDONE USP

DMF 34741979

BIDACHEM SPAInactiveCHLORTHALIDONE U.S.P.

DMF 46011982

ORION CORP LTDInactiveCHLORTHALIDONE USP XX AND BP 80

DMF 46821982

E MERCKInactiveCHLORTHALIDONE USP

DMF 50161983

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveCHLORTHALIDONE

DMF 51041983

SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENTInactiveCHLORTHALIDONE

DMF 51091983

CIBA GEIGY LTDInactiveCHLORTHALIDONE USP

DMF 69101987

AInactiveCHLORTHALIDONE

DMF 82041989

AMOLI ORGANICS PVT LTDInactiveCHLORTHALIDONE USP

DMF 266482012

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Sep 18, 2019	SUPPL -17	View Letter (PDF)
Jun 7, 2004	SUPPL -10	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 20, 1988

No patent or exclusivity listings for this strength.

#002 — 25MG

RLDBX

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 12, 1992