Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 13, 2019

DrugPatentWatch Database Preview

ENALAPRIL MALEATE - Generic Drug Details

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What are the generic 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, 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, Bausch, Astrazeneca, Acp Nimble, Apotex Inc, Dr Reddys Labs Ltd, Taro Pharm Inds, and Upsher Smith Labs, 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 seven patent family members in four countries.

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

Drug Prices for ENALAPRIL MALEATE

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Drug Sales Revenue Trends for ENALAPRIL MALEATE

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Recent Clinical Trials for ENALAPRIL MALEATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Manchester University NHS Foundation TrustPhase 2
South Tees Hospitals NHS Foundation TrustPhase 3
Newcastle-upon-Tyne Hospitals NHS TrustPhase 3

See all ENALAPRIL MALEATE clinical trials

Recent Litigation for ENALAPRIL MALEATE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Silvergate Pharmaceuticals, Inc. v. Bionpharma, Inc.2017-01-05
Silvergate Pharmaceuticals Inc. v. Bionpharma Inc.2016-09-28
Apotex, Inc. v. Mylan Pharmaceuticals, Inc.2012-04-20

See all ENALAPRIL MALEATE litigation

Pharmacology for ENALAPRIL MALEATE
Medical Subject Heading (MeSH) Categories for ENALAPRIL MALEATE
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
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
Mylan ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 075472-003 Aug 22, 2000 DISCN No No   Start Trial   Start Trial   Start Trial
Taro ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 075657-001 Jan 23, 2001 AB RX No No   Start Trial   Start Trial   Start Trial
Ivax Sub Teva Pharms ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 075482-002 Aug 22, 2000 DISCN No No   Start Trial   Start Trial   Start Trial
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch VASOTEC enalapril maleate TABLET;ORAL 018998-005 Jul 26, 1988   Start Trial   Start Trial
Bausch VASOTEC enalapril maleate TABLET;ORAL 018998-003 Dec 24, 1985   Start Trial   Start Trial
Bausch VASOTEC enalapril maleate TABLET;ORAL 018998-002 Dec 24, 1985   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Medtronic

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