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Last Updated: February 22, 2024

Ranolazine - Generic Drug Details


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What are the generic sources for ranolazine and what is the scope of patent protection?

Ranolazine is the generic ingredient in three branded drugs marketed by Spil, Menarini Intl, Accord Hlthcare, Actavis Elizabeth, Ajanta Pharma Ltd, Alkem Labs Ltd, Amneal, Ani Pharms, Aurobindo Pharma, Cadila, Cipla, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, I3 Pharms, Lupin Ltd, Mankind Pharma, Micro Labs, Novast Labs, Piramal Hlthcare Uk, Praxgen, Rising, Sciegen Pharms Inc, Sun Pharm, Sunshine, Unichem, and Vkt Pharma, and is included in twenty-six NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ranolazine has one patent family member in one country.

There are twenty-three drug master file entries for ranolazine. Twenty-six suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ranolazine
Drug Prices for ranolazine

See drug prices for ranolazine

Recent Clinical Trials for ranolazine

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

SponsorPhase
Maria Sklodowska-Curie National Research Institute of OncologyPhase 3
Polish Medical Research AgencyPhase 3
RenJi HospitalPhase 4

See all ranolazine clinical trials

Generic filers with tentative approvals for RANOLAZINE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial1000MGTABLET, EXTENDED RELEASE;ORAL
⤷  Try a Trial⤷  Try a Trial500MGTABLET, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Medical Subject Heading (MeSH) Categories for ranolazine
Paragraph IV (Patent) Challenges for RANOLAZINE
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 ranolazine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mankind Pharma RANOLAZINE ranolazine TABLET, EXTENDED RELEASE;ORAL 212284-002 Feb 12, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rising RANOLAZINE ranolazine TABLET, EXTENDED RELEASE;ORAL 212889-002 Jan 28, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
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
Micro Labs RANOLAZINE ranolazine TABLET, EXTENDED RELEASE;ORAL 211745-001 Feb 27, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hetero Labs Ltd Iii RANOLAZINE ranolazine TABLET, EXTENDED RELEASE;ORAL 212788-002 May 5, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Spil ASPRUZYO SPRINKLE ranolazine GRANULES, EXTENDED RELEASE;ORAL 216018-002 Feb 28, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
I3 Pharms RANOLAZINE ranolazine TABLET, EXTENDED RELEASE;ORAL 213517-001 Apr 27, 2022 AB RX No 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 ranolazine

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 021526-001 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
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 ranolazine

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 ranolazine

Country Patent Number Title Estimated Expiration
European Patent Office 3409273 FORMULATIONS MULTIPARTICULAIRES À LIBÉRATION PROLONGÉE DE RANOLAZINE (EXTENDED RELEASE MULTIPARTICULATES OF RANOLAZINE) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ranolazine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1109558 09C0001 France ⤷  Try a Trial PRODUCT NAME: RANOLAZINE; REGISTRATION NO/DATE: EU/1/08/462/001-006 20080714
1109558 SPC/GB08/058 United Kingdom ⤷  Try a 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
1109558 2008/034 Ireland ⤷  Try a 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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