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Last Updated: March 19, 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
Pfizer Pharms ACCURETIC hydrochlorothiazide; quinapril hydrochloride TABLET;ORAL 020125-002 Dec 28, 1999 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal Pharms VALSARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; valsartan TABLET;ORAL 204382-004 Aug 11, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Barr RESERPINE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; reserpine TABLET;ORAL 084579-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Macleods Pharms Ltd VALSARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; valsartan TABLET;ORAL 203145-001 Apr 19, 2013 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Roxane HYDROCHLOROTHIAZIDE W/ RESERPINE hydrochlorothiazide; reserpine TABLET;ORAL 084603-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ivax Sub Teva Pharms HYDROCHLOROTHIAZIDE hydrochlorothiazide TABLET;ORAL 083177-001 Approved Prior to Jan 1, 1982 AB RX Yes 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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