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Last Updated: September 29, 2020

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RANOLAZINE Drug Profile

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

Ranolazine is a drug marketed by Actavis Elizabeth, Ajanta Pharma Ltd, Ani Pharms Inc, Cadila, Cipla, Glenmark Pharms Ltd, Lupin Ltd, Mankind Pharma, Micro Labs, Sciegen Pharms Inc, Sun Pharm, Sungen Pharma, and Sunshine Lake. and is included in thirteen NDAs.

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

US ANDA Litigation and Generic Entry Outlook for Ranolazine

A generic version of RANOLAZINE was approved as ranolazine by LUPIN LTD 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
Vanderbilt University Medical CenterPhase 2
Maimonides Medical CenterPhase 2
University of Kansas Medical CenterPhase 2

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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
Actavis Elizabeth RANOLAZINE ranolazine TABLET, EXTENDED RELEASE;ORAL 208862-002 May 28, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Micro Labs RANOLAZINE ranolazine TABLET, EXTENDED RELEASE;ORAL 211745-001 Feb 27, 2020 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
Cadila RANOLAZINE ranolazine TABLET, EXTENDED RELEASE;ORAL 210188-002 Aug 19, 2019 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

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Harvard Business School
Colorcon

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