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Last Updated: August 13, 2020

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FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE - Generic Drug Details

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

Fosinopril sodium; hydrochlorothiazide is the generic ingredient in two branded drugs marketed by Ani Pharms Inc, Aurobindo Pharma, Emcure Pharms Ltd, Invagen Pharms, Mylan, Sandoz, Sun Pharm Inds Ltd, Teva, and Bristol Myers Squibb, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for fosinopril sodium; hydrochlorothiazide. Five suppliers are listed for this compound.

Summary for FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE
Recent Clinical Trials for FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE

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

SponsorPhase
Ranbaxy Laboratories LimitedN/A

See all FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE clinical trials

Pharmacology for FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE
Paragraph IV (Patent) Challenges for FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE
Tradename Dosage Ingredient NDA Submissiondate
MONOPRIL-HCT TABLET;ORAL fosinopril sodium; hydrochlorothiazide 020286

US Patents and Regulatory Information for FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol Myers Squibb MONOPRIL-HCT fosinopril sodium; hydrochlorothiazide TABLET;ORAL 020286-001 Nov 30, 1994 DISCN Yes No   Start Trial   Start Trial   Start Trial
Ani Pharms Inc FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE fosinopril sodium; hydrochlorothiazide TABLET;ORAL 077144-001 Aug 16, 2005 DISCN No No   Start Trial   Start Trial   Start Trial
Emcure Pharms Ltd FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE fosinopril sodium; hydrochlorothiazide TABLET;ORAL 079025-001 Sep 17, 2010 DISCN No No   Start Trial   Start Trial   Start Trial
Ani Pharms Inc FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE fosinopril sodium; hydrochlorothiazide TABLET;ORAL 077144-002 Aug 16, 2005 DISCN No No   Start Trial   Start Trial   Start Trial
Emcure Pharms Ltd FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE fosinopril sodium; hydrochlorothiazide TABLET;ORAL 079025-002 Sep 17, 2010 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE fosinopril sodium; hydrochlorothiazide TABLET;ORAL 077705-002 Aug 14, 2006 DISCN No No   Start Trial   Start Trial   Start Trial
Bristol Myers Squibb MONOPRIL-HCT fosinopril sodium; hydrochlorothiazide TABLET;ORAL 020286-002 Nov 30, 1994 DISCN Yes No   Start Trial   Start Trial   Start Trial
>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 FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Express Scripts
Dow
Medtronic
Boehringer Ingelheim
McKinsey

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