ENALAPRIL MALEATE Drug Patent Profile

When do Enalapril Maleate patents expire, and what generic alternatives are available?

Enalapril Maleate is a drug marketed by Alkem Labs Ltd, Amneal, Annora Pharma, Bionpharma Inc, 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, Chartwell Rx, Cosette, Dr Reddys Labs Ltd, Nostrum Labs Inc, Rising, and Taro Pharm Inds. and is included in twenty-eight NDAs.

The generic ingredient in ENALAPRIL MALEATE is enalapril maleate; hydrochlorothiazide. There are twenty-seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the enalapril maleate; hydrochlorothiazide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Enalapril Maleate

A generic version of ENALAPRIL MALEATE was approved as enalapril maleate; hydrochlorothiazide by COSETTE on September 18^th, 2001.

Summary for ENALAPRIL MALEATE

US Patents:	0
Applicants:	25
NDAs:	28
Finished Product Suppliers / Packagers:	33
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	16
Patent Applications:	1,951
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information 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

Anatomical Therapeutic Chemical (ATC) Classes for ENALAPRIL MALEATE

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

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

ENALAPRIL MALEATE is protected by zero US patents and one FDA Regulatory Exclusivity.

FDA Regulatory Exclusivity protecting ENALAPRIL MALEATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ivax Sub Teva Pharms	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	enalapril maleate; hydrochlorothiazide	TABLET;ORAL	075736-002	Mar 25, 2003		DISCN	No	No
Sandoz	ENALAPRIL MALEATE	enalapril maleate	TABLET;ORAL	075048-001	Aug 22, 2000		DISCN	No	No
Krka Dd Novo Mesto	ENALAPRIL MALEATE	enalapril maleate	TABLET;ORAL	075369-002	Aug 22, 2000		DISCN	No	No
Sun Pharm Inds Ltd	ENALAPRIL MALEATE	enalapril maleate	TABLET;ORAL	075556-001	Aug 22, 2000		DISCN	No	No
Watson Labs	ENALAPRIL MALEATE	enalapril maleate	TABLET;ORAL	075501-004	Aug 22, 2000		DISCN	No	No
Sandoz Inc	ENALAPRIL MALEATE	enalapril maleate	TABLET;ORAL	075496-001	Aug 22, 2000	AB	RX	No	No
Sun Pharm Inds Ltd	ENALAPRIL MALEATE	enalapril maleate	TABLET;ORAL	075556-002	Aug 22, 2000		DISCN	No	No