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Last Updated: August 13, 2020

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What are the generic drug sources for hydrochlorothiazide and what is the scope of patent protection?

Hydrochlorothiazide is the generic ingredient in sixty-three branded drugs marketed by Alembic Pharms Ltd, Apotex, Aurobindo Pharma, Hikma Intl Pharms, Ipca Labs Ltd, Ivax Sub Teva Pharms, Jubilant Cadista, Lannett Co Inc, Mylan, Prinston Inc, Sciegen Pharms Inc, Sun Pharm Inds Inc, Unichem, Allergan, 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 Inc, Impax Labs, Inwood Labs, Leading Pharma Llc, 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, Yaopharma Co Ltd, Merck, Abbvie, Sanofi Aventis Us, Apotex Inc, Atlas Pharms Llc, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Hikma, Hisun Pharm Hangzhou, Lupin Ltd, Macleods Pharms Ltd, Sandoz, Unichem Labs Ltd, Watson Labs Inc, Schering, Glaxosmithkline, Aurobindo, Corepharma, Heritage Pharma, Invagen Pharms, Lupin, Sun Pharm Inds Ltd, Alvogen, Merck Sharp Dohme, Cadista Pharms, Teva Pharms, Torrent Pharms, Zydus Pharms Usa Inc, Par Pharm, Parke Davis, Purepac Pharm, Concordia, Us Pharms Holdings I, Sun Pharm Inds, Glenmark Pharms, Ucb Inc, Daiichi Sankyo, Teva Pharms Usa, Torrent, Umedica Labs Pvt Ltd, Wyeth Ayerst, Wyeth Pharms Inc, Duramed Pharms Barr, Ani Pharms Inc, Pfizer Pharms, Apotex Corp, Pharmeral, Gd Searle Llc, Mutual Pharm, Ivax Pharms, Lederle, Upsher Smith, Boehringer Ingelheim, Glenmark Pharms Ltd, Zydus Pharms, Glaxosmithkline Llc, Cadila, Vitarine, Am Therap, Pliva, and Quantum Pharmics, and is included in three hundred and twenty-nine NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are thirty-two drug master file entries for hydrochlorothiazide. Fifty-one suppliers are listed for this compound. There are eight tentative approvals for this compound.



Drug Sales Revenue Trends for HYDROCHLOROTHIAZIDE

See drug sales revenues for HYDROCHLOROTHIAZIDE

Recent Clinical Trials for HYDROCHLOROTHIAZIDE

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

University of IowaEarly Phase 1
Capital Medical UniversityN/A
Pharmtechnology LLCPhase 1

See all HYDROCHLOROTHIAZIDE clinical trials

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

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
Usl Pharma HYDROCHLOROTHIAZIDE hydrochlorothiazide TABLET;ORAL 087752-001 Apr 19, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Inwood Labs HYDROCHLOROTHIAZIDE hydrochlorothiazide TABLET;ORAL 085067-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd VALSARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; valsartan TABLET;ORAL 202519-003 Mar 21, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Apotex Inc VALSARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; valsartan TABLET;ORAL 203026-003 Mar 21, 2013 DISCN No No   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim MICARDIS HCT hydrochlorothiazide; telmisartan TABLET;ORAL 021162-001 Nov 17, 2000 AB RX Yes No   Start Trial   Start Trial   Start Trial
Apotex Corp QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; quinapril hydrochloride TABLET;ORAL 091524-001 Mar 12, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Parke Davis METHYLDOPA AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; methyldopa TABLET;ORAL 071900-001 Nov 23, 1987 DISCN No No   Start Trial   Start Trial   Start 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.