HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM - Generic Drug Details

What are the generic sources for hydrochlorothiazide; losartan potassium and what is the scope of patent protection?

Hydrochlorothiazide; losartan potassium is the generic ingredient in two branded drugs marketed by Organon, Alembic Pharms Ltd, Apotex, Aurobindo Pharma, Granules, Hikma, Ipca Labs Ltd, Jubilant Cadista, Lupin Ltd, Macleods Pharms Ltd, Mylan, Prinston Inc, Sandoz, Teva Pharms, Torrent Pharms, Unichem, Watson Labs, and Zydus Pharms Usa Inc, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

Twenty-nine suppliers are listed for this compound.

Summary for HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

US Patents:	0
Tradenames:	2
Applicants:	18
NDAs:	18
Finished Product Suppliers / Packagers:	29
Clinical Trials:	15
DailyMed Link:	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM at DailyMed

Recent Clinical Trials for HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

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

Sponsor	Phase
Shanghai Jiao Tong University School of Medicine	Phase 4
Kyushu University	Phase 3
Federico II University	Phase 4

See all HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM clinical trials

Pharmacology for HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Drug Class	Angiotensin 2 Receptor Blocker Thiazide Diuretic
Mechanism of Action	Angiotensin 2 Receptor Antagonists
Physiological Effect	Increased Diuresis

Paragraph IV (Patent) Challenges for HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
HYZAAR	Tablets	hydrochlorothiazide; losartan potassium	100 mg/12.5 mg	020387	1	2006-04-04
HYZAAR	Tablets	hydrochlorothiazide; losartan potassium	50 mg/12.5 mg and 100 mg/25 mg	020387	1	2004-05-24

US Patents and Regulatory Information for HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apotex	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; losartan potassium	TABLET;ORAL	090150-002	Aug 11, 2010		DISCN	No	No
Sandoz	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; losartan potassium	TABLET;ORAL	077948-002	Oct 6, 2010	AB	RX	No	No
Teva Pharms	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; losartan potassium	TABLET;ORAL	077157-002	Apr 6, 2010	AB	RX	No	No
Unichem	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; losartan potassium	TABLET;ORAL	204832-002	Jul 21, 2017	AB	RX	No	No

Expired US Patents for HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387-001	Apr 28, 1995
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387-001	Apr 28, 1995
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387-003	Oct 20, 2005
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387-001	Apr 28, 1995