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Last Updated: July 3, 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 freedom to operate?

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. Four suppliers are listed for this compound.

Summary for fosinopril sodium; hydrochlorothiazide
Recent Clinical Trials for fosinopril sodium; hydrochlorothiazide

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SponsorPhase
Ranbaxy Laboratories LimitedN/A

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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
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
Teva FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE fosinopril sodium; hydrochlorothiazide TABLET;ORAL 076945-002 Jul 5, 2006 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
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb MONOPRIL-HCT fosinopril sodium; hydrochlorothiazide TABLET;ORAL 020286-001 Nov 30, 1994   Start Trial   Start Trial
Bristol Myers Squibb MONOPRIL-HCT fosinopril sodium; hydrochlorothiazide TABLET;ORAL 020286-001 Nov 30, 1994   Start Trial   Start Trial
Bristol Myers Squibb MONOPRIL-HCT fosinopril sodium; hydrochlorothiazide TABLET;ORAL 020286-002 Nov 30, 1994   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Baxter
Dow
Medtronic
Johnson and Johnson
AstraZeneca

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