CHLOROTHIAZIDE - Generic Drug Details

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

Chlorothiazide is the generic ingredient in eleven branded drugs marketed by Salix Pharms, Abc Holding, Hikma Intl Pharms, Lederle, Mylan, Sandoz, Watson Labs, Rising, Am Regent, Fresenius Kabi Usa, Rk Pharma, Sagent Pharms Inc, Sun Pharm, Merck, Par Pharm, and Hikma, and is included in twenty-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are forty-two drug master file entries for chlorothiazide. One supplier is listed for this compound.

Sponsor	Phase
University of Virginia	Phase 4
Vanderbilt University	Phase 4
National Heart, Lung, and Blood Institute (NHLBI)	Phase 1

Sponsor

Phase

University of Virginia

Phase 4

Vanderbilt University

Phase 4

National Heart, Lung, and Blood Institute (NHLBI)

Phase 1

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan	CHLOROTHIAZIDE	chlorothiazide	TABLET;ORAL	084217-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Par Pharm	METHYLDOPA AND CHLOROTHIAZIDE	chlorothiazide; methyldopa	TABLET;ORAL	070783-001	Nov 6, 1987		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Merck	DIUPRES-500	chlorothiazide; reserpine	TABLET;ORAL	011635-006	Aug 26, 1987		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Salix Pharms	DIURIL	chlorothiazide	SUSPENSION;ORAL	011870-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sun Pharm	CHLOROTHIAZIDE SODIUM	chlorothiazide sodium	INJECTABLE;INJECTION	091546-001	Jul 26, 2011	AP	RX	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

US Patents:	0
Tradenames:	11
Applicants:	16
NDAs:	29
Drug Master File Entries:	42
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	8
Patent Applications:	7,096
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for CHLOROTHIAZIDE
What excipients (inactive ingredients) are in CHLOROTHIAZIDE?	CHLOROTHIAZIDE excipients list
DailyMed Link:	CHLOROTHIAZIDE at DailyMed

Drug Class	Thiazide Diuretic
Physiological Effect	Increased Diuresis