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Last Updated: July 4, 2020

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EPANED KIT Drug Profile


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Which patents cover Epaned Kit, and what generic alternatives are available?

Epaned Kit is a drug marketed by Silvergate Pharms and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has four patent family members in four countries.

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

US ANDA Litigation and Generic Entry Outlook for Epaned Kit

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

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Paragraph IV (Patent) Challenges for EPANED KIT
Tradename Dosage Ingredient NDA Submissiondate
EPANED KIT FOR SOLUTION;ORAL enalapril maleate 204308 2016-06-21

US Patents and Regulatory Information for EPANED KIT

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   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   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
Silvergate Pharms EPANED KIT enalapril maleate FOR SOLUTION;ORAL 204308-001 Aug 13, 2013 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Merck
McKesson
Express Scripts
AstraZeneca
Johnson and Johnson

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