Enalapril maleate - Generic Drug Details

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, Alkem Labs Ltd, Amneal, Annora Pharma, Bionpharma Inc, Azurity, Aiping Pharm Inc, Apothecon, Aurobindo Pharma Usa, Beximco Pharms Usa, Heritage Pharma, Ivax Sub Teva Pharms, Krka Dd Novo Mesto, Mylan, Prinston Inc, Sandoz, Sandoz Inc, Sun Pharm Inds Ltd, Taro, Watson Labs, Wockhardt Ltd, Bausch, Astrazeneca, Chartwell Rx, Cosette, Dr Reddys Labs Ltd, Nostrum Labs Inc, Rising, and Taro Pharm Inds, and is included in thirty-three NDAs. There are thirteen 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 eighteen drug master file entries for enalapril maleate. Thirty-one suppliers are listed for this compound.

Summary for enalapril maleate

International Patents:	8
US Patents:	13
Tradenames:	7
Applicants:	29
NDAs:	33
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	31
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	16
Patent Applications:	3,679
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
Newcastle-upon-Tyne Hospitals NHS Trust	Phase 3
South Tees Hospitals NHS Foundation Trust	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	Strength	NDA	ANDAs Submitted	Submissiondate
EPANED	Oral Solution	enalapril maleate	1 mg/mL	208686	1	2018-08-31
EPANED KIT	Powder for Oral Solution	enalapril maleate	1 mg/mL	204308	1	2016-06-21

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
Azurity	EPANED	enalapril maleate	SOLUTION;ORAL	208686-001	Sep 20, 2016	AB	RX	Yes	Yes			Y
Krka Dd Novo Mesto	ENALAPRIL MALEATE	enalapril maleate	TABLET;ORAL	075370-001	Aug 22, 2000		DISCN	No	No
Chartwell Rx	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	enalapril maleate; hydrochlorothiazide	TABLET;ORAL	076116-001	Sep 19, 2001		DISCN	No	No
Ivax Sub Teva Pharms	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	enalapril maleate; hydrochlorothiazide	TABLET;ORAL	075736-002	Mar 25, 2003		DISCN	No	No
Beximco Pharms Usa	ENALAPRIL MALEATE	enalapril maleate	TABLET;ORAL	075621-004	Aug 22, 2000		DISCN	No	No
Azurity	EPANED	enalapril maleate	SOLUTION;ORAL	208686-001	Sep 20, 2016	AB	RX	Yes	Yes			Y
Ivax Sub Teva Pharms	ENALAPRIL MALEATE	enalapril maleate	TABLET;ORAL	075482-003	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	018998-001	Dec 24, 1985
Bausch	VASOTEC	enalapril maleate	TABLET;ORAL	018998-002	Dec 24, 1985
Bausch	VASOTEC	enalapril maleate	TABLET;ORAL	018998-003	Dec 24, 1985

International Patents for enalapril maleate

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3429581	FORMULATIONS D'ÉNALAPRIL (ENALAPRIL FORMULATIONS)
World Intellectual Property Organization (WIPO)	2017161339
Brazil	112015007592	composições de enalapril
European Patent Office	2903690	COMPOSITIONS D'ÉNALAPRIL (ENALAPRIL COMPOSITIONS)
Spain	2770403
Brazil	112018068960	formulações de enalapril
World Intellectual Property Organization (WIPO)	2014055667