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Last Updated: March 29, 2024

RANEXA Drug Patent Profile


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When do Ranexa patents expire, and what generic alternatives are available?

Ranexa is a drug marketed by Menarini Intl 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-six 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
Fondazione Policlinico Universitario Agostino Gemelli IRCCSPhase 4
Policlinico Universitario Agostino GemelliPhase 4
Menarini International Operations Luxembourg SAPhase 2

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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
Menarini Intl RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-001 Feb 12, 2007 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Menarini Intl RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-002 Jan 27, 2006 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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
Menarini Intl RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-002 Jan 27, 2006 ⤷  Try a Trial ⤷  Try a Trial
Menarini Intl RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-002 Jan 27, 2006 ⤷  Try a Trial ⤷  Try a Trial
Menarini Intl RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-001 Feb 12, 2007 ⤷  Try a Trial ⤷  Try a Trial
Menarini Intl RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-001 Feb 12, 2007 ⤷  Try a Trial ⤷  Try a Trial
Menarini Intl RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-002 Jan 27, 2006 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for RANEXA

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Menarini International Operations Luxembourg S.A. (MIOL) Ranexa (previously Latixa) ranolazine EMEA/H/C/000805
Ranexa is indicated as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line anti-anginal therapies (such as beta-blockers and / or calcium antagonists).,
Authorised no no no 2008-07-08
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for RANEXA

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

Country Patent Number Title Estimated Expiration
Spain 532565 ⤷  Try a Trial
Norway 841968 ⤷  Try a Trial
Hong Kong 91989 CARDIOSELECTIVE ARYLOXY-AND ARYLTHIO-HYDROXYPROPYL PIPERAZINYL ACETANILIDES WHICH AFFECT CALCIUM ENTRY ⤷  Try a Trial
Russian Federation 2002126615 ⤷  Try a Trial
Denmark 1096937 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for RANEXA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1109558 1/2009 Austria ⤷  Try a Trial PRODUCT NAME: RANOLAZIN ODER EIN SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/08/462/001-006 20080709
1109558 122008000065 Germany ⤷  Try a Trial PRODUCT NAME: RANOLAZIN ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/08/462/001-006 20080709
1109558 2008/034 Ireland ⤷  Try a Trial PRODUCT NAME: RANOLAZINE OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/08/462/001 20080709
1109558 PA2008017 Lithuania ⤷  Try a Trial PRODUCT NAME: RANOLAZINUM; REGISTRATION NO/DATE: EU/1/08/462/001 - EU/1/08/462/006 20080709
1109558 C01109558/01 Switzerland ⤷  Try a Trial FORMER OWNER: ROCHE PALTO ALTO LLC, US
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.