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Last Updated: January 25, 2022

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Ranolazine - Generic Drug Details

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What are the generic sources for ranolazine and what is the scope of freedom to operate?

Ranolazine is the generic ingredient in two branded drugs marketed by Gilead, Accord Hlthcare, Actavis Elizabeth, Ajanta Pharma Ltd, Alkem Labs Ltd, Amneal, Ani Pharms, Cadila, Cipla, Glenmark Pharms Ltd, Graviti Pharms, Lupin Ltd, Mankind Pharma, Micro Labs, Praxgen, Sciegen Pharms Inc, Sun Pharm, and Sunshine, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-three drug master file entries for ranolazine. Twenty suppliers are listed for this compound. There are two tentative approvals for this compound.

Drug Prices for ranolazine

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Recent Clinical Trials for ranolazine

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

SponsorPhase
Vanderbilt University Medical CenterPhase 2
Policlinico Universitario Agostino GemelliPhase 4
Fondazione Policlinico Universitario Agostino Gemelli IRCCSPhase 4

See all ranolazine clinical trials

Generic filers with tentative approvals for RANOLAZINE
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free1000MGTABLET, EXTENDED RELEASE;ORAL
⤷  Try it Free⤷  Try it Free500MGTABLET, EXTENDED RELEASE;ORAL
⤷  Try it Free⤷  Try it Free1GMTABLET, 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
Anatomical Therapeutic Chemical (ATC) Classes for ranolazine
Paragraph IV (Patent) Challenges for RANOLAZINE
Tradename Dosage Ingredient NDA Submissiondate
RANEXA TABLET, EXTENDED RELEASE;ORAL ranolazine 021526 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
Sunshine RANOLAZINE ranolazine TABLET, EXTENDED RELEASE;ORAL 211865-002 Mar 23, 2020 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Actavis Elizabeth RANOLAZINE ranolazine TABLET, EXTENDED RELEASE;ORAL 208862-002 May 28, 2019 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Amneal RANOLAZINE ranolazine TABLET, EXTENDED RELEASE;ORAL 207690-002 Mar 11, 2021 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Glenmark Pharms Ltd RANOLAZINE ranolazine TABLET, EXTENDED RELEASE;ORAL 211082-002 Jul 5, 2019 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Gilead RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-001 Feb 12, 2007 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Graviti Pharms RANOLAZINE ranolazine TABLET, EXTENDED RELEASE;ORAL 212889-001 Jan 28, 2021 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 021526-002 Jan 27, 2006 ⤷  Try it Free ⤷  Try it Free
Gilead RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-002 Jan 27, 2006 ⤷  Try it Free ⤷  Try it Free
Gilead RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-002 Jan 27, 2006 ⤷  Try it Free ⤷  Try it Free
Gilead RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-001 Feb 12, 2007 ⤷  Try it Free ⤷  Try it Free
Gilead RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-001 Feb 12, 2007 ⤷  Try it Free ⤷  Try it Free
Gilead RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-002 Jan 27, 2006 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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