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Last Updated: April 10, 2021

DrugPatentWatch Database Preview

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. Nineteen suppliers are listed for this compound. Additional details are available on the ranolazine profile page.

DrugPatentWatch® 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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Drug patent expirations by year for RANEXA
Drug Prices for RANEXA

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Drug Sales Revenue Trends for RANEXA

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Recent Clinical Trials for RANEXA

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SponsorPhase
IRCCS San RaffaelePhase 2
Menarini International Operations Luxembourg SAPhase 2
Gilead SciencesPhase 2

See all RANEXA clinical trials

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 021526-001 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 122008000065 Germany   Start Trial PRODUCT NAME: RANOLAZIN ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/08/462/001-006 20080709
1109558 09C0001 France   Start Trial PRODUCT NAME: RANOLAZINE; REGISTRATION NO/DATE: EU/1/08/462/001-006 20080714
1109558 SPC/GB08/058 United Kingdom   Start Trial PRODUCT NAME: RANOLAZINE OR A SALT OR SOLVATE THEREOF; REGISTERED: UK EU/1/08/462/001 20080714; UK EU/1/08/462/002 20080714; UK EU/1/08/462/003 20080714; UK EU/1/08/462/004 20080714; UK EU/1/08/462/005 20080714; UK EU/1/08/462/006 20080714
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Johnson and Johnson
Moodys
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Medtronic

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