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Last Updated: November 21, 2024

ENALAPRIL MALEATE - Generic Drug Details


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

Enalapril maleate is the generic ingredient in seven branded drugs marketed by Azurity, Alkem Labs Ltd, Amneal, Annora Pharma, Aurobindo Pharma, Bionpharma, Aiping Pharm Inc, Apothecon, Aurobindo Pharma Usa, Beximco Pharms Usa, Chartwell Rx, Heritage Pharma, Ivax Sub Teva Pharms, Krka Dd Novo Mesto, Mylan, Prinston Inc, Sandoz Inc, Sun Pharm Inds Ltd, Taro, Unique Pharm, Watson Labs, Wockhardt Ltd, Bausch, Astrazeneca, Cosette, Dr Reddys Labs Ltd, Nostrum Labs Inc, Rising, and Taro Pharm Inds, and is included in thirty-five NDAs. There are thirteen 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 eighteen drug master file entries for enalapril maleate. Thirty-five 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-upon-Tyne Hospitals NHS TrustPhase 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 Strength NDA ANDAs Submitted Submissiondate
EPANED Oral Solution enalapril maleate 1 mg/mL 208686 1 2018-08-31
EPANED KIT Powder for Oral Solution enalapril maleate 1 mg/mL 204308 1 2016-06-21

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
Sandoz Inc ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 075496-002 Aug 22, 2000 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma Usa ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 075480-001 Aug 22, 2000 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Unique Pharm ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 218531-004 Sep 19, 2024 AB RX 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
>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 ⤷  Sign Up ⤷  Sign Up
Bausch VASOTEC enalapril maleate TABLET;ORAL 018998-003 Dec 24, 1985 ⤷  Sign Up ⤷  Sign Up
Bausch VASOTEC enalapril maleate TABLET;ORAL 018998-002 Dec 24, 1985 ⤷  Sign Up ⤷  Sign Up
Bausch 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

EU/EMA Drug Approvals for ENALAPRIL MALEATE

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Proveca Pharma Limited Aqumeldi Enalapril maleate EMEA/H/C/005731
Treatment of heart failure.
Authorised no no no 2023-11-15
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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