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HEMICLOR

NDA

CHLORTHALIDONE | N218647 | PRM PHARMA LLC

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

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Today

12667554

Sep. 4, 2045

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

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 | 2 NDCs

Highest NADAC/Unit

$0.9573

per ea

Lowest NADAC/Unit

$0.9573

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
50742028530HEMICLOR 12.5 MG TABLET	$0.9573	EA	Brand	—	2026-06-17
50742028590HEMICLOR 12.5 MG TABLET	$0.9573	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 | 2 NDCs (2 FSS)

Lowest Price

$22.36

Highest Price

$67.08

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
50742-0285-30HEMICLOR 12.5MG TAB	$22.36	FSS	Ingenus Pharmaceuticals, LLC	04/30/2026
50742-0285-90HEMICLOR 12.5MG TAB	$67.08	FSS	Ingenus Pharmaceuticals, LLC	04/30/2026

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

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

1 letter from Drugs@FDA

Date	Submission	Document
Mar 18, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 12.5MG

RLD

1 patent0 exclusivities▴

TABLET;ORAL | Approved: Mar 17, 2025

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
12667554Newly listed — daily FDA feed, not yet in monthly Orange Book edition	Sep 4, 2045	—	—	Yes	—	—