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Last Updated: May 14, 2021

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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, Cadista Pharms, Hikma, Ipca Labs Ltd, 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 seventeen NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-two drug master file entries for hydrochlorothiazide; losartan potassium. Thirty-one suppliers are listed for this compound.

Summary for HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Recent Clinical Trials for HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

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

SponsorPhase
Shanghai Jiao Tong University School of MedicinePhase 4
Kyushu UniversityPhase 3
Agenzia Italiana del FarmacoPhase 4

See all HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM clinical trials

Pharmacology for HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Paragraph IV (Patent) Challenges for HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Tradename Dosage Ingredient NDA Submissiondate
HYZAAR TABLET;ORAL hydrochlorothiazide; losartan potassium 020387 2006-04-04
HYZAAR TABLET;ORAL hydrochlorothiazide; losartan potassium 020387 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
Zydus Pharms Usa Inc LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; losartan potassium TABLET;ORAL 078385-002 Oct 6, 2010 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Mylan LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; losartan potassium TABLET;ORAL 091652-003 Oct 6, 2010 DISCN No No   Get Started for $10   Get Started for $10   Get Started for $10
Ipca Labs Ltd LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; losartan potassium TABLET;ORAL 201682-002 Mar 1, 2013 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon HYZAAR hydrochlorothiazide; losartan potassium TABLET;ORAL 020387-002 Nov 10, 1998   Get Started for $10   Get Started for $10
Organon HYZAAR hydrochlorothiazide; losartan potassium TABLET;ORAL 020387-001 Apr 28, 1995   Get Started for $10   Get Started for $10
Organon HYZAAR hydrochlorothiazide; losartan potassium TABLET;ORAL 020387-001 Apr 28, 1995   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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