Is there a generic for Enalapril maleate?

Yes. The FDA Orange Book lists 23 approved generic (ANDA) applications for Enalapril maleate, referencing the brand EPANED. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Enalapril maleate?

EPANED (NDA 208686, AZURITY) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Enalapril maleate?

The Orange Book lists 13 patents against Enalapril maleate products, with the earliest listed expiry in 2032. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Enalapril maleate are approved?

Enalapril maleate is approved in the following dosage forms: for solution, solution, tablet.

FDA Orange Book · active-ingredient family

Enalapril maleate

Enalapril maleate: 3 brands, 23 generics; first approved Dec 24, 1985; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 23 ANDA applications approved.

Earliest patent expiry Nov 06, 2032

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Nov 06, 2032

in 6 yr 4 mo

Brand (NDA) products

Originator applications

EPANEDRLDRS
AZURITYNDA 2086862016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML SOLUTION ORAL Rx AB
EPANED KITRLD
AZURITYNDA 2043082013
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML FOR SOLUTION ORAL Discontinued —
VASOTECRLD
BAUSCHNDA 01899819884 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
20MG TABLET ORAL Rx AB
2.5MG TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	SOLUTION	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	FOR SOLUTION	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB
2.5MG	TABLET	ORAL	Rx	AB

Generic (ANDA) products (23)

Abbreviated applications

ENALAPRIL MALEATE
UNIQUE PHARMANDA 21853120244 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Rx AB
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
20MG TABLET ORAL Rx AB
ENALAPRIL MALEATE
AUROBINDO PHARMAANDA 2164582024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML SOLUTION ORAL Rx AB
ENALAPRIL MALEATE
PRINSTON INCANDA 21327320224 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Rx AB
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
20MG TABLET ORAL Rx AB
ENALAPRIL MALEATE
AMNEALANDA 2128942022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML SOLUTION ORAL Rx AB
ENALAPRIL MALEATE
ALKEM LABS LTDANDA 2137142022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML SOLUTION ORAL Rx AB
ENALAPRIL MALEATE
ANNORA PHARMAANDA 2144672022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML SOLUTION ORAL Rx AB
ENALAPRIL MALEATE
BIONPHARMAANDA 2124082021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML SOLUTION ORAL Rx AB
ENALAPRIL MALEATE
AIPING PHARM INCANDA 07517820014 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
2.5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
20MG TABLET ORAL Rx AB
ENALAPRIL MALEATE
TAROANDA 07565720014 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Rx AB
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
20MG TABLET ORAL Rx AB
ENALAPRIL MALEATE
APOTHECONANDA 07558320004 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued —
5MG TABLET ORAL Discontinued —
10MG TABLET ORAL Discontinued —
20MG TABLET ORAL Discontinued —
ENALAPRIL MALEATE
AUROBINDO PHARMA USAANDA 07548020004 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued —
5MG TABLET ORAL Discontinued —
10MG TABLET ORAL Discontinued —
20MG TABLET ORAL Discontinued —
ENALAPRIL MALEATE
CHARTWELL RXANDA 07504820004 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued —
5MG TABLET ORAL Discontinued —
10MG TABLET ORAL Discontinued —
20MG TABLET ORAL Discontinued —
ENALAPRIL MALEATE
HERITAGE PHARMAANDA 07547920004 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Rx AB
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
20MG TABLET ORAL Rx AB
ENALAPRIL MALEATE
IVAX SUB TEVA PHARMSANDA 07548220004 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued —
5MG TABLET ORAL Discontinued —
10MG TABLET ORAL Discontinued —
20MG TABLET ORAL Discontinued —
ENALAPRIL MALEATE
KRKA DD NOVO MESTOANDA 07537020002 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued —
5MG TABLET ORAL Discontinued —
ENALAPRIL MALEATE
KRKA DD NOVO MESTOANDA 07536920002 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Discontinued —
20MG TABLET ORAL Discontinued —
ENALAPRIL MALEATE
MYLANANDA 07547220004 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued —
5MG TABLET ORAL Discontinued —
10MG TABLET ORAL Discontinued —
20MG TABLET ORAL Discontinued —
ENALAPRIL MALEATE
REGCON HOLDINGSANDA 07562120004 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued —
5MG TABLET ORAL Discontinued —
10MG TABLET ORAL Discontinued —
20MG TABLET ORAL Discontinued —
ENALAPRIL MALEATE
SANDOZ INCANDA 07549620002 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Rx AB
5MG TABLET ORAL Rx AB
ENALAPRIL MALEATE
SANDOZ INCANDA 07545920002 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Rx AB
20MG TABLET ORAL Rx AB
ENALAPRIL MALEATE
SENORES PHARMSANDA 07548320004 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Rx AB
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
20MG TABLET ORAL Rx AB
ENALAPRIL MALEATE
SUN PHARM INDS LTDANDA 07555620004 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued —
5MG TABLET ORAL Discontinued —
10MG TABLET ORAL Discontinued —
20MG TABLET ORAL Discontinued —
ENALAPRIL MALEATE
WATSON LABSANDA 07550120004 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued —
5MG TABLET ORAL Discontinued —
10MG TABLET ORAL Discontinued —
20MG TABLET ORAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	SOLUTION	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	SOLUTION	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	SOLUTION	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	SOLUTION	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	SOLUTION	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB
2.5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	—
5MG	TABLET	ORAL	Discontinued	—
10MG	TABLET	ORAL	Discontinued	—
20MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	—
5MG	TABLET	ORAL	Discontinued	—
10MG	TABLET	ORAL	Discontinued	—
20MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	—
5MG	TABLET	ORAL	Discontinued	—
10MG	TABLET	ORAL	Discontinued	—
20MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	—
5MG	TABLET	ORAL	Discontinued	—
10MG	TABLET	ORAL	Discontinued	—
20MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	—
5MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Discontinued	—
20MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	—
5MG	TABLET	ORAL	Discontinued	—
10MG	TABLET	ORAL	Discontinued	—
20MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	—
5MG	TABLET	ORAL	Discontinued	—
10MG	TABLET	ORAL	Discontinued	—
20MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	—
5MG	TABLET	ORAL	Discontinued	—
10MG	TABLET	ORAL	Discontinued	—
20MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	—
5MG	TABLET	ORAL	Discontinued	—
10MG	TABLET	ORAL	Discontinued	—
20MG	TABLET	ORAL	Discontinued	—

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8778366	Nov 06, 2032	in 6 yr 4 mo	U-3
9968553	Nov 06, 2032	in 6 yr 4 mo	U-71
8568747	Nov 06, 2032	in 6 yr 4 mo	Product
9855214	Nov 06, 2032	in 6 yr 4 mo	Product
9808442	Mar 25, 2036	in 9 yr 9 mo	U-71
10154987	Mar 25, 2036	in 9 yr 9 mo	U-3
11040023	Mar 25, 2036	in 9 yr 9 mo	Product
9669008	Mar 25, 2036	in 9 yr 9 mo	Product
10772868	Mar 25, 2036	in 9 yr 9 mo	Product
10786482	Mar 25, 2036	in 9 yr 9 mo	Product
10039745	Mar 25, 2036	in 9 yr 9 mo	Product
11173141	Mar 25, 2036	in 9 yr 9 mo	Product
11141405	Mar 25, 2036	in 9 yr 9 mo	Product

Approval history

FDA approval span

First approval

Dec 24, 1985

41 yr 3 mo ago

Most recent approval

Sep 19, 2024

1 yr 11 mo ago

Approvals span 1985–2024 across 26 FDA applications.

Brand (NDA) 312%

Generic (ANDA) 2388%

Enalapril maleate: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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