Hydrochlorothiazide; losartan potassium - Generic Drug Details

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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.

Thirty-one suppliers are listed for this compound.

Summary for hydrochlorothiazide; losartan potassium

US Patents:	0
Tradenames:	2
Applicants:	18
NDAs:	18
Finished Product Suppliers / Packagers:	31
Clinical Trials:	15
DailyMed Link:	hydrochlorothiazide; losartan potassium at DailyMed

Recent Clinical Trials for hydrochlorothiazide; losartan potassium

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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

Anatomical Therapeutic Chemical (ATC) Classes for hydrochlorothiazide; losartan potassium

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

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Glossary

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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
Aurobindo Pharma	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; losartan potassium	TABLET;ORAL	091629-001	Oct 6, 2010	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Torrent Pharms	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; losartan potassium	TABLET;ORAL	090528-001	Oct 6, 2010		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; losartan potassium	TABLET;ORAL	077157-003	Apr 6, 2010	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for hydrochlorothiazide; losartan potassium

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

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