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Last Updated: October 21, 2020

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Enalapril maleate - Generic Drug Details

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What are the generic drug 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 eight patent family members in five countries.

There are twenty-seven drug master file entries for enalapril maleate. Thirty 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
University of DurhamPhase 3
Newcastle UniversityPhase 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
Beximco Pharms Usa ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 075621-004 Aug 22, 2000 DISCN No No   Start Trial   Start Trial   Start Trial
Beximco Pharms Usa ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 075621-001 Aug 22, 2000 DISCN No No   Start Trial   Start Trial   Start Trial
Dr Reddys Labs Ltd ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE enalapril maleate; hydrochlorothiazide TABLET;ORAL 075909-001 Oct 15, 2001 AB RX No No   Start Trial   Start Trial   Start Trial
Silvergate Pharms EPANED KIT enalapril maleate FOR SOLUTION;ORAL 204308-001 Aug 13, 2013 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Mylan ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 075472-003 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 018998-001 Dec 24, 1985   Start Trial   Start Trial
Bausch VASOTEC enalapril maleate TABLET;ORAL 018998-003 Dec 24, 1985   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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