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Last Updated: February 28, 2021

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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 patent protection?

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

There are twenty-three drug master file entries for ranolazine. Nineteen 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
Maimonides Medical CenterPhase 2
University of Kansas Medical CenterPhase 2

See all ranolazine clinical trials

Generic filers with tentative approvals for RANOLAZINE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial1000MGTABLET, EXTENDED RELEASE;ORAL
  Start Trial  Start Trial500MGTABLET, EXTENDED RELEASE;ORAL
  Start Trial  Start Trial1GMTABLET, 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 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
Cipla RANOLAZINE ranolazine TABLET, EXTENDED RELEASE;ORAL 211291-002 May 28, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Ajanta Pharma Ltd RANOLAZINE ranolazine TABLET, EXTENDED RELEASE;ORAL 210054-001 May 28, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Glenmark Pharms Ltd RANOLAZINE ranolazine TABLET, EXTENDED RELEASE;ORAL 211082-001 Jul 5, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Sungen Pharma RANOLAZINE ranolazine TABLET, EXTENDED RELEASE;ORAL 212781-001 Mar 23, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Gilead RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-002 Jan 27, 2006 AB RX Yes No   Start Trial   Start Trial   Start Trial
Ani Pharms Inc RANOLAZINE ranolazine TABLET, EXTENDED RELEASE;ORAL 210482-001 Oct 29, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Sunshine RANOLAZINE ranolazine TABLET, EXTENDED RELEASE;ORAL 211865-001 Mar 23, 2020 AB RX No No   Start Trial   Start Trial   Start 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
Gilead RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-002 Jan 27, 2006   Start Trial   Start Trial
Gilead RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-002 Jan 27, 2006   Start Trial   Start Trial
Gilead RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-001 Feb 12, 2007   Start Trial   Start Trial
Gilead RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-001 Feb 12, 2007   Start Trial   Start Trial
Gilead RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-001 Feb 12, 2007   Start Trial   Start Trial
Gilead RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-002 Jan 27, 2006   Start Trial   Start Trial
Gilead RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-002 Jan 27, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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