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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, Bionpharma Inc, 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-nine NDAs. There are eleven 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-three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for enalapril maleate

International Patents:	8
US Patents:	11
Tradenames:	7
Applicants:	22
NDAs:	29
Drug Master File Entries:	27
Finished Product Suppliers / Packagers:	33
Raw Ingredient (Bulk) Api Vendors:	75
Clinical Trials:	14
Patent Applications:	4,017
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
What excipients (inactive ingredients) are in enalapril maleate?	enalapril maleate excipients list
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
South Tees Hospitals NHS Foundation Trust	Phase 3
Newcastle-upon-Tyne Hospitals NHS Trust	Phase 3

See all enalapril maleate clinical trials

Generic filers with tentative approvals for ENALAPRIL MALEATE

Applicant	Application No.	Strength	Dosage Form
		1MG/ML	SOLUTION;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Apothecon	ENALAPRIL MALEATE	enalapril maleate	TABLET;ORAL	075583-003	Aug 22, 2000		DISCN	No	No
Wockhardt Ltd	ENALAPRIL MALEATE	enalapril maleate	TABLET;ORAL	075483-003	Aug 22, 2000	AB	RX	No	No
Astrazeneca	LEXXEL	enalapril maleate; felodipine	TABLET, EXTENDED RELEASE;ORAL	020668-002	Oct 28, 1998		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

International Patents for enalapril maleate

Country	Patent Number	Estimated Expiration
Spain	2770403
World Intellectual Property Organization (WIPO)	2014055667
European Patent Office	3429581