➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Dow
Harvard Business School
McKinsey
Baxter
Johnson and Johnson
Moodys

Last Updated: August 4, 2020

DrugPatentWatch Database Preview

RANOLAZINE - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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, 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 fourteen NDAs. Additional information is available in the individual branded drug profile pages.

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

Drug Prices for RANOLAZINE

See drug prices for RANOLAZINE

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
Sunshine Lake RANOLAZINE ranolazine TABLET, EXTENDED RELEASE;ORAL 211865-002 Mar 23, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Lupin Ltd RANOLAZINE ranolazine TABLET, EXTENDED RELEASE;ORAL 201046-002 Jul 29, 2013 AB RX 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
Sciegen Pharms Inc RANOLAZINE ranolazine TABLET, EXTENDED RELEASE;ORAL 211829-001 Jun 4, 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

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 021526-002 Jan 27, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Moodys
Merck
Baxter
Johnson and Johnson
Colorcon

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.