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Enalapril maleate - Generic Drug Details

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What are the generic drug sources for enalapril maleate and what is the scope of patent protection?

Enalapril maleate is the generic ingredient in seven branded drugs marketed by Silvergate Pharms, Azurity, Apothecon, Beximco Pharms Usa, Heritage Pharma, Ivax Sub Teva Pharms, Krka Dd Novo Mesto, Mylan, Nostrum Labs Inc, Sandoz, Sandoz Inc, Sun Pharm Inds Ltd, Taro, Watson Labs, Wockhardt Ltd, Bausch, Astrazeneca, Cosette, Dr Reddys Labs Ltd, Taro Pharm Inds, and Upsher Smith Labs, and is included in twenty-eight NDAs. There are eight patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Enalapril maleate has eight patent family members in five countries.

There are twenty-seven drug master file entries for enalapril maleate. Thirty suppliers are listed for this compound.

Summary for enalapril maleate

International Patents:	8
US Patents:	8
Tradenames:	7
Applicants:	21
NDAs:	28
Drug Master File Entries:	27
Suppliers / Packagers:	30
Bulk Api Vendors:	65
Clinical Trials:	14
Patent Applications:	3,778
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for enalapril maleate
Drug Sales Revenues:	Drug sales revenues for enalapril maleate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for enalapril maleate
DailyMed Link:	enalapril maleate at DailyMed

See drug prices for enalapril maleate

See drug sales revenues for enalapril maleate

Recent Clinical Trials for enalapril maleate

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

Sponsor	Phase
Manchester University NHS Foundation Trust	Phase 2
University of Durham	Phase 3
Newcastle University	Phase 3

See all enalapril maleate clinical trials

Pharmacology for enalapril maleate

Drug Class	Angiotensin Converting Enzyme Inhibitor
Mechanism of Action	Angiotensin-converting Enzyme Inhibitors
Physiological Effect	Decreased Blood Pressure

Medical Subject Heading (MeSH) Categories for enalapril maleate

Angiotensin-Converting Enzyme Inhibitors

Antihypertensive Agents

Paragraph IV (Patent) Challenges for ENALAPRIL MALEATE

Tradename	Dosage	Ingredient	NDA	Submissiondate
EPANED	SOLUTION;ORAL	enalapril maleate	208686	2018-08-31
EPANED KIT	FOR SOLUTION;ORAL	enalapril maleate	204308	2016-06-21
VASOTEC	TABLET;ORAL	enalapril maleate	018998

US Patents and Regulatory Information for enalapril maleate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Beximco Pharms Usa	ENALAPRIL MALEATE	enalapril maleate	TABLET;ORAL	075621-004	Aug 22, 2000		DISCN	No	No
Beximco Pharms Usa	ENALAPRIL MALEATE	enalapril maleate	TABLET;ORAL	075621-001	Aug 22, 2000		DISCN	No	No
Dr Reddys Labs Ltd	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	enalapril maleate; hydrochlorothiazide	TABLET;ORAL	075909-001	Oct 15, 2001	AB	RX	No	No
Silvergate Pharms	EPANED KIT	enalapril maleate	FOR SOLUTION;ORAL	204308-001	Aug 13, 2013		DISCN	Yes	No			Y
Mylan	ENALAPRIL MALEATE	enalapril maleate	TABLET;ORAL	075472-003	Aug 22, 2000		DISCN	No	No

Expired US Patents for enalapril maleate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	VASOTEC	enalapril maleate	TABLET;ORAL	018998-005	Jul 26, 1988
Bausch	VASOTEC	enalapril maleate	TABLET;ORAL	018998-002	Dec 24, 1985
Bausch	VASOTEC	enalapril maleate	TABLET;ORAL	018998-001	Dec 24, 1985
Bausch	VASOTEC	enalapril maleate	TABLET;ORAL	018998-003	Dec 24, 1985

International Patents for enalapril maleate

Country	Patent Number	Estimated Expiration
European Patent Office	2903690
Canada	2887379
European Patent Office	3429581
Spain	2770403
Brazil	112015007592