Hydrochlorothiazide - Generic Drug Details

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

Hydrochlorothiazide is the generic ingredient in sixty-three branded drugs marketed by Alembic Pharms Ltd, Apotex, Aurobindo Pharma, Chartwell Molecular, Hikma Intl Pharms, Ipca Labs Ltd, Ivax Sub Teva Pharms, Jubilant Cadista, Norvium Bioscience, 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, Impax Labs, Inwood Labs, Lannett Co Inc, Leading, Mast Mm, Mylan, 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, Alkem Labs Ltd, 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, Natco, Glaxosmithkline Llc, Cadila, Vitarine, Aurobindo Pharma Usa, Am Therap, Pliva, Quantum Pharmics, Rubicon, Amneal Pharms, Mylan Pharms Inc, and Zydus Lifesciences, and is included in three hundred and thirty-three NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for hydrochlorothiazide

US Patents:	0
Tradenames:	63
Applicants:	118
NDAs:	333
Drug Master File Entries:	32
Finished Product Suppliers / Packagers:	45
Raw Ingredient (Bulk) Api Vendors:	134
Clinical Trials:	383
Patent Applications:	6,812
Drug Prices:	Drug price trends for hydrochlorothiazide
Drug Sales Revenues:	Drug sales revenues for hydrochlorothiazide
What excipients (inactive ingredients) are in hydrochlorothiazide?	hydrochlorothiazide excipients list
DailyMed Link:	hydrochlorothiazide at DailyMed

See drug prices for hydrochlorothiazide

See drug sales revenues for hydrochlorothiazide

Recent Clinical Trials for hydrochlorothiazide

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

Sponsor	Phase
University of Bern	Phase 2
Insel Gruppe AG, University Hospital Bern	Phase 2
University Medical Center Groningen	Phase 3

See all hydrochlorothiazide clinical trials

Generic filers with tentative approvals for HYDROCHLOROTHIAZIDE

Applicant	Application No.	Strength	Dosage Form
		12.5MG;300MG	TABLET;ORAL
		12.5MG;150MG	TABLET;ORAL
		25MG;300MG	TABLET; 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 Class	Thiazide Diuretic
Physiological Effect	Increased Diuresis

Medical Subject Heading (MeSH) Categories for hydrochlorothiazide

Antihypertensive Agents

Diuretics

Sodium Chloride Symporter Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for hydrochlorothiazide

C03AA	Thiazides, plain
C03A	LOW-CEILING DIURETICS, THIAZIDES
C03	DIURETICS
C	Cardiovascular system

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
Teva	METHYLDOPA AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; methyldopa	TABLET;ORAL	071821-001	Apr 8, 1988		DISCN	No	No
Merck	HYDRODIURIL	hydrochlorothiazide	TABLET;ORAL	011835-007	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Lupin Ltd	IRBESARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	201524-001	Feb 27, 2013	AB	RX	No	No