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Last Updated: August 4, 2020

DrugPatentWatch Database Preview

Fosinopril sodium - Generic Drug Details

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

Fosinopril sodium is the generic ingredient in four branded drugs marketed by Actavis Labs Fl Inc, Apotex Inc, Aurobindo Pharma Ltd, Invagen Pharms, Prinston Inc, Ranbaxy Labs Ltd, Teva, Upsher Smith Labs, Watson Labs, Bristol Myers Squibb, Ani Pharms Inc, Aurobindo Pharma, Emcure Pharms Ltd, Mylan, Sandoz, and Sun Pharm Inds Ltd, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for fosinopril sodium. Seven suppliers are listed for this compound.

Drug Prices for fosinopril sodium

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Drug Sales Revenue Trends for fosinopril sodium

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Recent Clinical Trials for fosinopril sodium

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SponsorPhase
The Second Affiliated Hospital of Dalian Medical UniversityPhase 4
First Affiliated Hospital of Zhejiang UniversityPhase 4
The First Affiliated Hospital of Anhui Medical UniversityPhase 4

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Pharmacology for fosinopril sodium
Medical Subject Heading (MeSH) Categories for fosinopril sodium
Paragraph IV (Patent) Challenges for FOSINOPRIL SODIUM
Tradename Dosage Ingredient NDA Submissiondate
MONOPRIL TABLET;ORAL fosinopril sodium 019915

US Patents and Regulatory Information for fosinopril sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE fosinopril sodium; hydrochlorothiazide TABLET;ORAL 079245-002 Jul 9, 2009 AB RX No Yes   Start Trial   Start Trial   Start Trial
Upsher Smith Labs FOSINOPRIL SODIUM fosinopril sodium TABLET;ORAL 076483-003 Apr 23, 2004 AB RX No No   Start Trial   Start Trial   Start Trial
Watson Labs FOSINOPRIL SODIUM fosinopril sodium TABLET;ORAL 077531-001 Aug 31, 2006 DISCN No No   Start Trial   Start Trial   Start Trial
Ranbaxy Labs Ltd FOSINOPRIL SODIUM fosinopril sodium TABLET;ORAL 076580-001 Apr 23, 2004 DISCN No No   Start Trial   Start Trial   Start Trial
Sandoz FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE fosinopril sodium; hydrochlorothiazide TABLET;ORAL 076961-001 Sep 28, 2005 AB RX No No   Start Trial   Start Trial   Start Trial
Apotex Inc FOSINOPRIL SODIUM fosinopril sodium TABLET;ORAL 076906-003 May 17, 2005 AB RX 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb MONOPRIL fosinopril sodium TABLET;ORAL 019915-003 May 16, 1991   Start Trial   Start Trial
Bristol Myers Squibb MONOPRIL fosinopril sodium TABLET;ORAL 019915-002 May 16, 1991   Start Trial   Start Trial
Bristol Myers Squibb MONOPRIL fosinopril sodium TABLET;ORAL 019915-002 May 16, 1991   Start Trial   Start Trial
Bristol Myers Squibb MONOPRIL fosinopril sodium TABLET;ORAL 019915-003 May 16, 1991   Start Trial   Start Trial
Bristol Myers Squibb MONOPRIL fosinopril sodium TABLET;ORAL 019915-003 May 16, 1991   Start Trial   Start Trial
Bristol Myers Squibb MONOPRIL fosinopril sodium TABLET;ORAL 019915-004 Mar 28, 1995   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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