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Last Updated: July 4, 2020

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RANEXA Drug Profile


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Which patents cover Ranexa, and what generic alternatives are available?

Ranexa is a drug marketed by Gilead and is included in one NDA.

The generic ingredient in RANEXA is ranolazine. There are twenty-three drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the ranolazine profile page.

US ANDA Litigation and Generic Entry Outlook for Ranexa

A generic version of RANEXA was approved as ranolazine by LUPIN LTD on July 29th, 2013.

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Paragraph IV (Patent) Challenges for RANEXA
Tradename Dosage Ingredient NDA Submissiondate
RANEXA TABLET, EXTENDED RELEASE;ORAL ranolazine 021526 2010-05-17

US Patents and Regulatory Information for RANEXA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-001 Feb 12, 2007 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Gilead RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-002 Jan 27, 2006 AB RX 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

Expired US Patents for RANEXA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-002 Jan 27, 2006   Start Trial   Start Trial
Gilead RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-001 Feb 12, 2007   Start Trial   Start Trial
Gilead RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-002 Jan 27, 2006   Start Trial   Start Trial
Gilead RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-001 Feb 12, 2007   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for RANEXA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1109558 CA 2008 00051 Denmark   Start Trial PRODUCT NAME: RANOLAZIN ELLER ET SALT DERAF
1109558 122008000065 Germany   Start Trial PRODUCT NAME: RANOLAZIN ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/08/462/001-006 20080709
1109558 300371 Netherlands   Start Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
1109558 2008/034 Ireland   Start Trial PRODUCT NAME: RANOLAZINE OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/08/462/001 20080709
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Johnson and Johnson
Moodys
Harvard Business School
McKesson
Medtronic

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