Fosinopril sodium - Generic Drug Details

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. Eight 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:	8
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

See drug prices for fosinopril sodium

See drug sales revenues for fosinopril sodium

Recent Clinical Trials for fosinopril sodium

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

Sponsor	Phase
Shanghai Changzheng Hospital	Phase 4
The First Affiliated Hospital of Zhengzhou University	Phase 4
Ruijin 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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	076961-001	Sep 28, 2005	AB	RX	No	No
Watson Labs	FOSINOPRIL SODIUM	fosinopril sodium	TABLET;ORAL	076987-001	Dec 23, 2004		DISCN	No	No
Sandoz	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	076961-002	Sep 28, 2005	AB	RX	No	No
Ani Pharms	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	077144-002	Aug 16, 2005		DISCN	No	No
Invagen Pharms	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	090228-001	Jul 9, 2009	AB	RX	No	No
Aurobindo Pharma	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	079245-001	Jul 9, 2009	AB	RX	No	No

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
Bristol Myers Squibb	MONOPRIL	fosinopril sodium	TABLET;ORAL	019915-004	Mar 28, 1995
Bristol Myers Squibb	MONOPRIL	fosinopril sodium	TABLET;ORAL	019915-002	May 16, 1991
Bristol Myers Squibb	MONOPRIL	fosinopril sodium	TABLET;ORAL	019915-003	May 16, 1991
Bristol Myers Squibb	MONOPRIL	fosinopril sodium	TABLET;ORAL	019915-002	May 16, 1991
Bristol Myers Squibb	MONOPRIL	fosinopril sodium	TABLET;ORAL	019915-004	Mar 28, 1995