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Last Updated: August 13, 2020

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EPANED Drug 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 eight patents protecting this drug and two Paragraph IV challenges.

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. 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

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 NDA Submissiondate
EPANED SOLUTION;ORAL enalapril maleate 208686 2018-08-31

US Patents and Regulatory Information for EPANED

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Azurity EPANED enalapril maleate SOLUTION;ORAL 208686-001 Sep 20, 2016 RX Yes Yes   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
Azurity EPANED enalapril maleate SOLUTION;ORAL 208686-001 Sep 20, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
Azurity EPANED enalapril maleate SOLUTION;ORAL 208686-001 Sep 20, 2016 RX Yes Yes   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   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   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:

Johnson and Johnson
Express Scripts
Boehringer Ingelheim
Dow
Colorcon
Moodys

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