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Last Updated: June 13, 2021

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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. Nine 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

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

SponsorPhase
Ruijin HospitalPhase 4
The First Affiliated Hospital of Zhengzhou UniversityPhase 4
Shanghai Changzheng HospitalPhase 4

See all fosinopril sodium clinical trials

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
Ani Pharms Inc FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE fosinopril sodium; hydrochlorothiazide TABLET;ORAL 077144-002 Aug 16, 2005 DISCN No No   Get Started Free   Get Started Free   Get Started Free
Apotex Inc FOSINOPRIL SODIUM fosinopril sodium TABLET;ORAL 076906-003 May 17, 2005 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Ranbaxy Labs Ltd FOSINOPRIL SODIUM fosinopril sodium TABLET;ORAL 076580-002 Apr 23, 2004 DISCN No No   Get Started Free   Get Started Free   Get Started Free
Sun Pharm Inds Ltd FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE fosinopril sodium; hydrochlorothiazide TABLET;ORAL 076739-001 Dec 17, 2004 DISCN No No   Get Started Free   Get Started Free   Get Started Free
>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 019915-004 Mar 28, 1995   Get Started Free   Get Started Free
Bristol Myers Squibb MONOPRIL fosinopril sodium TABLET;ORAL 019915-004 Mar 28, 1995   Get Started Free   Get Started Free
Bristol Myers Squibb MONOPRIL fosinopril sodium TABLET;ORAL 019915-002 May 16, 1991   Get Started Free   Get Started Free
Bristol Myers Squibb MONOPRIL fosinopril sodium TABLET;ORAL 019915-002 May 16, 1991   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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