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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.
Summary for ENALAPRIL MALEATE
| International Patents: | 7 |
| US Patents: | 8 |
| Tradenames: | 7 |
| Applicants: | 21 |
| NDAs: | 28 |
| Drug Master File Entries: | 27 |
| Suppliers / Packagers: | 29 |
| Bulk Api Vendors: | 97 |
| Clinical Trials: | 14 |
| Patent Applications: | 7,091 |
| 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 |
Recent Clinical Trials for ENALAPRIL MALEATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Manchester University NHS Foundation Trust | Phase 2 |
| South Tees Hospitals NHS Foundation Trust | Phase 3 |
| Newcastle-upon-Tyne Hospitals NHS Trust | Phase 3 |
Recent Litigation for ENALAPRIL MALEATE
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| 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 |
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
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 |
International Patents for ENALAPRIL MALEATE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2014055667 | Start Trial |
| European Patent Office | 3429581 | Start Trial |
| Canada | 2887379 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.