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Last Updated: May 11, 2024

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, Chartwell Rx, Invagen Pharms, Prinston Inc, Ranbaxy Labs Ltd, Teva, Upsher Smith Labs, Watson Labs, Bristol Myers Squibb, Ani Pharms, Aurobindo Pharma, Avet Lifesciences, 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.

Summary for fosinopril sodium

US Patents:	0
Tradenames:	4
Applicants:	17
NDAs:	22
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	5
Patent Applications:	3,161
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for fosinopril sodium
What excipients (inactive ingredients) are in fosinopril sodium?	fosinopril sodium excipients list
DailyMed Link:	fosinopril sodium at DailyMed

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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

Sponsor	Phase
The Second Affiliated Hospital of Dalian Medical University	Phase 4
Sichuan Provincial People's Hospital	Phase 4
Shanghai Changzheng Hospital	Phase 4

See all fosinopril sodium clinical trials

Pharmacology for fosinopril sodium

Drug Class	Angiotensin Converting Enzyme Inhibitor
Mechanism of Action	Angiotensin-converting Enzyme Inhibitors

Medical Subject Heading (MeSH) Categories for fosinopril sodium

Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents

Anatomical Therapeutic Chemical (ATC) Classes for fosinopril sodium

C09AA	ACE inhibitors, plain
C09A	ACE INHIBITORS, PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

US Patents and Regulatory Information for fosinopril sodium

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ani Pharms	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	077144-001	Aug 16, 2005		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Aurobindo Pharma Ltd	FOSINOPRIL SODIUM	fosinopril sodium	TABLET;ORAL	091163-003	Mar 30, 2011	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Apotex Inc	FOSINOPRIL SODIUM	fosinopril sodium	TABLET;ORAL	076906-002	May 17, 2005	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a 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

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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	⤷ Try a Trial	⤷ Try a Trial
Bristol Myers Squibb	MONOPRIL	fosinopril sodium	TABLET;ORAL	019915-002	May 16, 1991	⤷ Try a Trial	⤷ Try a Trial
Bristol Myers Squibb	MONOPRIL	fosinopril sodium	TABLET;ORAL	019915-002	May 16, 1991	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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