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Last Updated: March 19, 2024

EPANED Drug Patent Profile


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When do Epaned patents expire, and when can generic versions of Epaned launch?

Epaned is a drug marketed by Azurity and Silvergate Pharms and is included in two NDAs. There are thirteen patents protecting this drug and one Paragraph IV challenge.

This drug has three patent family members in three countries.

The generic ingredient in EPANED is enalapril maleate. There are twenty-seven drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the enalapril maleate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Epaned

A generic version of EPANED was approved as enalapril maleate by HERITAGE PHARMA on August 22nd, 2000.

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Paragraph IV (Patent) Challenges for EPANED
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
EPANED Oral Solution enalapril maleate 1 mg/mL 208686 1 2018-08-31

US Patents and Regulatory Information for EPANED

EPANED is protected by seventeen US patents.

Patents protecting EPANED

Enalapril formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Enalapril formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HYPERTENSION

Enalapril formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING LEFT VENTRICULAR DYSFUNCTION

Enalapril formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING HYPERTENSION

Enalapril formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATMENT OF HEART FAILURE

Enalapril formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HEART FAILURE

Enalapril formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Enalapril formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Enalapril formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Enalapril formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Enalapril formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Enalapril formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATMENT OF HEART FAILURE

Enalapril formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HEART FAILURE

Enalapril formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING HYPERTENSION

Enalapril formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING LEFT VENTRICULAR DYSFUNCTION

Enalapril formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HYPERTENSION

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Silvergate Pharms EPANED KIT enalapril maleate FOR SOLUTION;ORAL 204308-001 Aug 13, 2013 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Silvergate Pharms EPANED KIT enalapril maleate FOR SOLUTION;ORAL 204308-001 Aug 13, 2013 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Azurity EPANED enalapril maleate SOLUTION;ORAL 208686-001 Sep 20, 2016 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Silvergate Pharms EPANED KIT enalapril maleate FOR SOLUTION;ORAL 204308-001 Aug 13, 2013 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for EPANED

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

International Patents for EPANED

See the table below for patents covering EPANED around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 3429581 FORMULATIONS D'ÉNALAPRIL (ENALAPRIL FORMULATIONS) ⤷  Try a Trial
Brazil 112018068960 formulações de enalapril ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2017161339 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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