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Last Updated: November 11, 2024

RANOLAZINE Drug Patent Profile


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When do Ranolazine patents expire, and when can generic versions of Ranolazine launch?

Ranolazine is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Ajanta Pharma Ltd, Alkem Labs Ltd, Allied, Amneal, Ani Pharms, Aurobindo Pharma, Cadila, Chartwell Rx, Cipla, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Mankind Pharma, Micro Labs, Novast Labs, Piramal, Praxgen, Rising, Sciegen Pharms Inc, Sun Pharm, Sunshine, Unichem, and Vkt Pharma. and is included in twenty-four NDAs.

The generic ingredient in RANOLAZINE is ranolazine. There are twenty-three drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ranolazine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Ranolazine

A generic version of RANOLAZINE was approved as ranolazine by CHARTWELL RX on July 29th, 2013.

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Drug patent expirations by year for RANOLAZINE
Drug Prices for RANOLAZINE

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Recent Clinical Trials for RANOLAZINE

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

See all RANOLAZINE clinical trials

Medical Subject Heading (MeSH) Categories for RANOLAZINE
Anatomical Therapeutic Chemical (ATC) Classes 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
Sun Pharm RANOLAZINE ranolazine TABLET, EXTENDED RELEASE;ORAL 211707-002 May 28, 2019 AB RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novast Labs RANOLAZINE ranolazine TABLET, EXTENDED RELEASE;ORAL 210668-001 Sep 27, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Unichem RANOLAZINE ranolazine TABLET, EXTENDED RELEASE;ORAL 213083-002 Mar 16, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mankind Pharma RANOLAZINE ranolazine TABLET, EXTENDED RELEASE;ORAL 212284-001 Feb 12, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Piramal RANOLAZINE ranolazine TABLET, EXTENDED RELEASE;ORAL 213085-002 Jul 25, 2023 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Micro Labs RANOLAZINE ranolazine TABLET, EXTENDED RELEASE;ORAL 211745-002 Feb 27, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity 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

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