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Last Updated: August 6, 2020

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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, Azurity, Apothecon, Beximco Pharms Usa, Heritage Pharma, Ivax Sub Teva Pharms, Krka Dd Novo Mesto, Mylan, Nostrum Labs Inc, Sandoz, Sandoz Inc, Sun Pharm Inds Ltd, Taro, Watson Labs, Wockhardt Ltd, Bausch, Astrazeneca, Cosette, 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-eight 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

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SponsorPhase
Manchester University NHS Foundation TrustPhase 2
Newcastle-upon-Tyne Hospitals NHS TrustPhase 3
University of DurhamPhase 3

See all enalapril maleate clinical trials

Pharmacology for enalapril maleate
Medical Subject Heading (MeSH) Categories for enalapril maleate
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 075480-001 Aug 22, 2000 DISCN No No   Start Trial   Start Trial   Start Trial
Taro ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 075657-002 Jan 23, 2001 AB RX No No   Start Trial   Start Trial   Start Trial
Wockhardt Ltd ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 075483-001 Aug 22, 2000 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm Inds Ltd ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 075556-004 Aug 22, 2000 DISCN No No   Start Trial   Start Trial   Start Trial
Nostrum Labs Inc ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE enalapril maleate; hydrochlorothiazide TABLET;ORAL 076486-002 Oct 27, 2004 AB RX No No   Start Trial   Start Trial   Start Trial
Sandoz ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 075048-004 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 018998-002 Dec 24, 1985   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 018998-001 Dec 24, 1985   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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