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Enalapril maleate - Generic Drug Details

What are the generic drug sources for enalapril maleate and what is the scope of enalapril maleate freedom to operate?

Enalapril maleate is the generic ingredient in seven branded drugs marketed by Silvergate Pharms, Apotex, Apothecon, Beximco Pharms Usa, Heritage Pharma, Ivax Sub Teva Pharms, Krka Dd Novo Mesto, Mylan, Sandoz, Sandoz Inc, Sun Pharm Inds Ltd, Taro, Watson Labs, Wockhardt Ltd, Valeant Pharms North, Astrazeneca, Apotex Inc, Dr Reddys Labs Ltd, G And W Labs Inc, Taro Pharm Inds, Upsher Smith Labs, and Valeant Intl, 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 six patent family members in four countries.

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

Summary for enalapril maleate

International Patents:	6
US Patents:	8
Tradenames:	7
Applicants:	22
NDAs:	28
Drug Master File Entries:	27
Suppliers / Packagers:	41
Bulk Api Vendors:	56
Clinical Trials:	14
Patent Applications:	6,585
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

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

Synonyms for enalapril maleate

(2S)-1-[(2S)-2-[[(1S)-1-(Ethoxycarbonyl)-3-phenylpropyl]amino]propanoyl]pyrrolidine-2-carboxylic aci
(2S)-1-[(2S)-2-[[(1S)-1-ethoxycarbonyl-3-phenyl-propyl]amino]propanoyl]pyrrolidine-2-carboxylic acid; maleic acid
(S,S,S)-Enalapril Maleate
(S)-(-)-1-[N-(1-Ethoxycarbonyl-3-phenylpropyl)-L-alanyl]-Lproline
(S)-1-(N-(1-(Ethoxycarbonyl)-3-phenylpropyl)-L-alanyl)-L-proline maleate
(S)-1-(N-(1-(Ethoxycarbonyl)-3-phenylpropyl)-L-alanyl)-L-proline maleate (1:1)
(S)-1-[N-[1-(ETHOXYCARBONYL)-3-PHENYLPROPYL]-L-ALANYL]-L-PROLINE MALEATE
(S)-N-[1-(Ethoxycarbonyl)-3-phenylpropyl]-Ala-Pro maleate salt
(Z)-but-2-enedioic acid; (2S)-1-[(2S)-2-[[(2S)-1-ethoxy-1-oxo-4-phenylbutan-2-yl]amino]propanoyl]pyrrolidine-2-carboxylic acid
(Z)-but-2-enedioic acid;(2S)-1-[(2S)-2-[[(2S)-1-ethoxy-1-oxo-4-phenylbutan-2-yl]amino]propanoyl]pyrrolidine-2-carboxylic acid
095E164
1-(N-((S)-1-Carboxy-3-phenylpropyl)-L-alanyl)-L-proline 1'-ethyl ester, maleate (1:1)
1-[N-[(S)-1-Ethoxycarbonyl-3-phenylpropyl]-L-alanyl]-L-proline Maleate
75847-73-3 (Parent)
76095-16-4
76420-75-2
77549-59-8
9O25354EPJ
A-Rin
AB0013100
AB2000386
AC1NTUS2
Acetensil
AKOS016340376
Alphrin
Amprace
AN-15422
Analept
AOB5651
Atens
Baripril
Benalapril
Benalipril
Biocronil
BQL
C20H28N2O5.C4H4O4
CCG-39221
CHEBI:4785
CHEMBL1200659
Controlvas
Converten
Convertin
Coprilor
Coroldil
CPD001906771
Crinoren
CS-2373
D00621
Dabonal
Defluin
Denapril
Ditensor
Ecapril
Ednit
Ednyt
EINECS 278-375-7
EINECS 278-460-9
Elfonal
Enacard
Enalabene
Enaladil
Enalapril (maleate)
enalapril hydrogen maleate
Enalapril maleate (JP17/USP)
Enalapril maleate (Vasotec)
Enalapril maleate [USAN:JAN]
Enalapril maleate [USAN:USP:JAN]
Enalapril maleate salt
Enalaprilmaleate
Enalasyn
Enaloc
Enalped
Enap
Enapren
Enapres
Enapril
Enaprin
Enarenal
Enaril
Envas
Epaned Kit
Eupressin
Feliberal
Glioten
Glioten;Renitec;Vasotec
H531
Herten
Hipoartel
Hipten
HMS1921B10
HMS2092L17
HMS2095P10
HMS2231D22
HMS2232I24
HMS3712P10
HMS501E10
HSDB 6529
HY-B0331A
Hytrol
I04-153
Innovace
Innovace Melt
Innovade
Inoprilat
Insup
Invoril
J10412
Kenopril
KM1738
Konveril
KS-1137
L-Proline, 1-(N-(1-(ethoxycarbonyl)-3-phenylpropyl)-L-alanyl)-, (S)-, (Z)-2-butenedioate (1:1)
L-Proline, N-((1S)-1-(ethoxycarbonyl)-3-phenylpropyl)-L-alanyl-, (2Z)-2-butenedioate (1:1)
Lapril
Lipraken
Lotrial
LS-118938
Mapryl
Mepril
MFCD00133304
MFCD00865774
Minipril
MK 421
MK 421 maleate
MK-421
MLS000028657
MLS001077272
MLS006010047
MolPort-003-666-389
N-((S)-1-Ethoxycarbonyl-3-phenylpropyl)-L-alanyl-L-proline maleate (1:1)
N-(1 (S)-ethoxycarbonyl-3-phenylpropyl)-L-alanyl-L-proline maleate
N-(1(S)-ethoxycarbonyl-3-phenylpropyl)-L-alanyl-L-proline maleate
N-[(2S)-1-ethoxy-1-oxo-4-phenylbutan-2-yl]-L-alanyl-L-proline (2Z)-but-2-enedioate
N-[1(S)-Ethoxycarbonyl-3-phenylpropyl]-L-alanyl-L-proline maleic acid salt
N-{N-[(S)-1-ethoxycarbonyl-3-phenylpropyl]-L-alanyl}-L-proline hydrogen maleate
Naprilene
Naritec
Neotensin
Norpril
NSC-758143
NSC758143
Nuril
Opera_ID_1793
OYFJQPXVCSSHAI-QFPUQLAESA-N
Palane
Pharmakon1600-01501214
Pres
Presil
Pressotec
Prestwick_197
Pril
Prilenap
Pulsol
Reca
Regomed
Renavace
Renitec
Reniten
Renivace
Renivace (TN)
Repantril
Ristalen
s1941
SAM002564252
SCHEMBL9
Sintec
SMR000058883
SMR000653477
SPECTRUM1501214
SR-01000000234
SR-01000000234-4
SR-05000001785
SR-05000001785-1
SW198780-2
Tenace
Tensazol
Unaril
UNII-9O25354EPJ
Vapresan
Vasopril
Vasotec
Xanef

US Patents and Regulatory Information for enalapril maleate

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Glossary

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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	075621-003	Aug 22, 2000		DISCN	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Apothecon	ENALAPRIL MALEATE	enalapril maleate	TABLET;ORAL	075583-004	Aug 22, 2000		DISCN	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Silvergate Pharms	EPANED	enalapril maleate	SOLUTION;ORAL	208686-001	Sep 20, 2016		RX	Yes	Yes	➤ Sign Up	➤ Sign Up	Y			➤ Sign Up
Wockhardt Ltd	ENALAPRIL MALEATE	enalapril maleate	TABLET;ORAL	075483-003	Aug 22, 2000	AB	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Sandoz Inc	ENALAPRIL MALEATE	enalapril maleate	TABLET;ORAL	075459-002	Aug 22, 2000	AB	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Silvergate Pharms	EPANED KIT	enalapril maleate	FOR SOLUTION;ORAL	204308-001	Aug 13, 2013		RX	Yes	Yes	➤ Sign Up	➤ Sign Up	Y			➤ Sign Up
Taro	ENALAPRIL MALEATE	enalapril maleate	TABLET;ORAL	075657-003	Jan 23, 2001	AB	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration

Expired US Patents for enalapril maleate

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

International Patents for enalapril maleate

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Country	Patent Number	Estimated Expiration
Canada	2887379	➤ Sign Up
European Patent Office	2903690	➤ Sign Up
World Intellectual Property Organization (WIPO)	2017161339	➤ Sign Up
Brazil	112015007592	➤ Sign Up
World Intellectual Property Organization (WIPO)	2014055667	➤ Sign Up
European Patent Office	3429581	➤ Sign Up
Country	Patent Number	Estimated Expiration