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Last Updated: November 30, 2022

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, Gilead, Accord Hlthcare, Actavis Elizabeth, Ajanta Pharma Ltd, Alkem Labs Ltd, Amneal, Ani Pharms, Cadila, Cipla, Glenmark Pharms Ltd, Graviti Pharms, Hetero Labs Ltd Iii, I3 Pharms, Lupin Ltd, Mankind Pharma, Micro Labs, Praxgen, Sciegen Pharms Inc, Sun Pharm, Sunshine, and Vkt Pharma, and is included in twenty-two NDAs. There is one patent 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-one suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for ranolazine
Drug Prices for ranolazine

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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
See Plans and PricingSee Plans and Pricing1000MGTABLET, EXTENDED RELEASE;ORAL
See Plans and PricingSee Plans and Pricing500MGTABLET, EXTENDED RELEASE;ORAL
See Plans and PricingSee Plans and Pricing1GMTABLET, 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
Amneal RANOLAZINE ranolazine TABLET, EXTENDED RELEASE;ORAL 207690-001 Mar 11, 2021 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hetero Labs Ltd Iii RANOLAZINE ranolazine TABLET, EXTENDED RELEASE;ORAL 212788-001 May 5, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ani Pharms RANOLAZINE ranolazine TABLET, EXTENDED RELEASE;ORAL 210482-001 Oct 29, 2019 DISCN No 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 ranolazine

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

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

Supplementary Protection Certificates for ranolazine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 2008/034 Ireland See Plans and Pricing PRODUCT NAME: RANOLAZINE OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/08/462/001 20080709
1109558 09C0001 France See Plans and Pricing PRODUCT NAME: RANOLAZINE; REGISTRATION NO/DATE: EU/1/08/462/001-006 20080714
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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