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Last Updated: March 28, 2024

Hydrochlorothiazide - Generic Drug Details


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What are the generic drug sources for hydrochlorothiazide and what is the scope of freedom to operate?

Hydrochlorothiazide is the generic ingredient in sixty-two branded drugs marketed by Alembic Pharms Ltd, Apotex, Aurobindo Pharma, Chartwell Molecular, Hikma Intl Pharms, Ipca Labs Ltd, Ivax Sub Teva Pharms, Jubilant Cadista, Mylan, Prinston Inc, Sciegen Pharms Inc, Sun Pharm Inds Inc, Unichem, Teva Branded Pharm, Morton Grove, Roxane, Novartis, Halsey, Abc Holding, Accord Hlthcare, Actavis Elizabeth, Alra, Ascot, Aurolife Pharma Llc, Barr, Chartwell Rx, Dava Pharms Inc, Elkins Sinn, Heather, Heritage Pharms, Impax Labs, Inwood Labs, Lannett Co Inc, Leading, Mast Mm, Mylan Pharms Inc, Oxford Pharms, Pvt Form, Solvay, Sun Pharm Industries, Superpharm, Teva, Usl Pharma, Vangard, Warner Chilcott, Watson Labs, Watson Labs Teva, West Ward, Whiteworth Town Plsn, Merck, Abbvie, Sanofi Aventis Us, Alembic, Apotex Inc, Atlas Pharms Llc, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Hikma, Hisun Pharm Hangzhou, Lupin Ltd, Macleods Pharms Ltd, Sandoz, Watson Labs Inc, Schering, Glaxosmithkline, Aurobindo, Corepharma, Epic Pharma Llc, Invagen Pharms, Lupin, Sun Pharm Inds Ltd, Almatica, Organon, Granules, Teva Pharms, Torrent Pharms, Zydus Pharms Usa Inc, Parke Davis, Purepac Pharm, Rising, Strides Pharma, Concordia, Validus Pharms, Sun Pharm Inds, Glenmark Pharms, Ucb Inc, Cosette, Natco Pharma Usa, Teva Pharms Usa, Torrent, Umedica, Zydus Pharms, Wyeth Ayerst, Wyeth Pharms Inc, Duramed Pharms Barr, Ani Pharms, Pfizer Pharms, Pharmeral, Pfizer, Mutual Pharm, Ivax Pharms, Lederle, Upsher Smith, Boehringer Ingelheim, Glenmark Pharms Ltd, Glaxosmithkline Llc, Cadila, Vitarine, Aurobindo Pharma Usa, Am Therap, Pliva, Quantum Pharmics, Rubicon, Amneal Pharms, and Zydus Lifesciences, and is included in three hundred and thirty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-two drug master file entries for hydrochlorothiazide. Forty-six suppliers are listed for this compound. There are seven tentative approvals for this compound.

Drug Prices for hydrochlorothiazide

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Drug Sales Revenue Trends for hydrochlorothiazide

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Recent Clinical Trials for hydrochlorothiazide

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University Medical Center GroningenPhase 3
Ligand Research, LLCPhase 1
Medical University of ViennaPhase 4

See all hydrochlorothiazide clinical trials

Generic filers with tentative approvals for HYDROCHLOROTHIAZIDE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial12.5MG;300MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial12.5MG;150MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial25MG;300MGTABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for hydrochlorothiazide
Drug ClassThiazide Diuretic
Physiological EffectIncreased Diuresis
Medical Subject Heading (MeSH) Categories for hydrochlorothiazide

US Patents and Regulatory Information for hydrochlorothiazide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 209281-002 Feb 7, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm Industries HYDROCHLOROTHIAZIDE hydrochlorothiazide TABLET;ORAL 083972-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Organon HYZAAR hydrochlorothiazide; losartan potassium TABLET;ORAL 020387-002 Nov 10, 1998 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Prinston Inc VALSARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; valsartan TABLET;ORAL 206083-004 Feb 8, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Duramed Pharms Barr PROPRANOLOL HYDROCHLORIDE & HYDROCHLOROTHIAZIDE hydrochlorothiazide; propranolol hydrochloride TABLET;ORAL 071126-001 Mar 2, 1987 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.