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Last Updated: May 24, 2022

RANEXA Drug Patent 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. Twenty-one suppliers are listed for this compound. Additional details are available on the ranolazine profile page.

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

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Policlinico Universitario Agostino GemelliPhase 4
Fondazione Policlinico Universitario Agostino Gemelli IRCCSPhase 4
Menarini International Operations Luxembourg SAPhase 2

See all RANEXA clinical trials

Paragraph IV (Patent) Challenges for RANEXA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
RANEXA Extended-release ranolazine 500 mg and 1000 mg 021526 1 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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Gilead RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-002 Jan 27, 2006 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Gilead RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-001 Feb 12, 2007 See Plans and Pricing See Plans and Pricing
Gilead RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-001 Feb 12, 2007 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for RANEXA

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

Country Patent Number Title Estimated Expiration
Hong Kong 1044284 See Plans and Pricing
Hungary 0104088 See Plans and Pricing
Argentina 053440 USO DE UNA FORMA DE DOSIFICACION FARMACEUTICA DE LIBERACION SOSTENIDA PARA LA MANUFACTURA DE UN MEDICAMENTO, DICHA FORMA DE DOSIFICACION FARMACEUTICA Y UNA TABLETA COMPRIMIDA See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for RANEXA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1109558 C01109558/01 Switzerland See Plans and Pricing FORMER OWNER: ROCHE PALTO ALTO LLC, US
1109558 SPC/GB08/058 United Kingdom See Plans and Pricing 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
1109558 122008000065 Germany See Plans and Pricing PRODUCT NAME: RANOLAZIN ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/08/462/001-006 20080709
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKinsey
Johnson and Johnson
Moodys
Harvard Business School
McKesson
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.