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Generated: September 22, 2017

DrugPatentWatch Database Preview

Ranolazine - Generic Drug Details

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What are the generic drug sources for ranolazine and what is the scope of ranolazine patent protection?

Ranolazine
is the generic ingredient in two branded drugs marketed by Gilead and Lupin Ltd, and is included in two NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ranolazine has ninety-two patent family members in twenty-nine countries.

There are fifteen drug master file entries for ranolazine. Four suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: ranolazine

Tradenames:2
Patents:10
Applicants:2
NDAs:2
Drug Master File Entries: see list15
Suppliers / Packagers: see list4
Bulk Api Vendors: see list78
Clinical Trials: see list79
Patent Applications: see list1,374
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:ranolazine at DailyMed

Tentative approvals for RANOLAZINE

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe500MGTABLET, EXTENDED RELEASE;ORAL
► Subscribe► Subscribe1000MGTABLET, EXTENDED RELEASE;ORAL
► Subscribe► Subscribe1GMTABLET, EXTENDED RELEASE;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead
RANEXA
ranolazine
TABLET, EXTENDED RELEASE;ORAL021526-001Feb 12, 2007RXYesYes► Subscribe► Subscribe ► Subscribe
Gilead
RANEXA
ranolazine
TABLET, EXTENDED RELEASE;ORAL021526-002Jan 27, 2006RXYesNo► Subscribe► Subscribe ► Subscribe
Gilead
RANEXA
ranolazine
TABLET, EXTENDED RELEASE;ORAL021526-002Jan 27, 2006RXYesNo► Subscribe► Subscribe ► Subscribe
Gilead
RANEXA
ranolazine
TABLET, EXTENDED RELEASE;ORAL021526-001Feb 12, 2007RXYesYes► Subscribe► SubscribeYY ► Subscribe
Gilead
RANEXA
ranolazine
TABLET, EXTENDED RELEASE;ORAL021526-002Jan 27, 2006RXYesNo► Subscribe► Subscribe ► Subscribe
Lupin Ltd
RANOLAZINE
ranolazine
TABLET, EXTENDED RELEASE;ORAL201046-001Jul 29, 2013DISCNNoNo► Subscribe► Subscribe► Subscribe
Gilead
RANEXA
ranolazine
TABLET, EXTENDED RELEASE;ORAL021526-001Feb 12, 2007RXYesYes► Subscribe► Subscribe ► Subscribe
Gilead
RANEXA
ranolazine
TABLET, EXTENDED RELEASE;ORAL021526-002Jan 27, 2006RXYesNo► Subscribe► SubscribeY ► Subscribe
Gilead
RANEXA
ranolazine
TABLET, EXTENDED RELEASE;ORAL021526-002Jan 27, 2006RXYesNo► Subscribe► Subscribe ► Subscribe
Lupin Ltd
RANOLAZINE
ranolazine
TABLET, EXTENDED RELEASE;ORAL201046-002Jul 29, 2013DISCNNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: ranolazine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead
RANEXA
ranolazine
TABLET, EXTENDED RELEASE;ORAL021526-002Jan 27, 2006► Subscribe► Subscribe
Gilead
RANEXA
ranolazine
TABLET, EXTENDED RELEASE;ORAL021526-001Feb 12, 2007► Subscribe► Subscribe
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International Patent Family for Ingredient: ranolazine

Country Document Number Estimated Expiration
Spain2177346► Subscribe
China1211086► Subscribe
Australia2001240092► Subscribe
Poland347073► Subscribe
Czech Republic20010880► Subscribe
World Intellectual Property Organization (WIPO)0013686► Subscribe
Portugal1109558► Subscribe
Czech Republic301341► Subscribe
Canada2402222► Subscribe
Canada2342390► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: RANOLAZINE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB08/058United Kingdom► SubscribePRODUCT NAME: RANOLAZINE OR A SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/08/462/001 - 006 20080714
2008017Lithuania► SubscribePRODUCT NAME: RANOLAZINUM; REGISTRATION NO/DATE: EU/1/08/462/001 - EU/1/08/462/006 20080709
1Finland► Subscribe
2008000065Germany► SubscribePRODUCT NAME: RANOLAZIN ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/08/462/001-006 20080709
504Luxembourg► Subscribe91504, EXPIRES: 20230709
08/034Ireland► SubscribePRODUCT NAME: RANOLAZINE OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/08/462/001 20080709
1109558/01Switzerland► SubscribePRODUCT NAME: RANOLAZINE; REGISTRATION NO/DATE: SWISSMEDIC 60553 13.04.2010
1/2009Austria► SubscribePRODUCT NAME: RANOLAZIN ODER EIN SALZ ODER SOLVAT DAVON
2008 00051Denmark► Subscribe
2008017,C1109558Lithuania► SubscribePRODUCT NAME: RANOLAZINUM; REGISTRATION NO/DATE: EU/1/08/462/001 - EU/1/08/462/006, 0080709
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

McKesson
Medtronic
Deloitte
Federal Trade Commission
Chinese Patent Office
AstraZeneca
Merck
Argus Health
Johnson and Johnson
McKinsey

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 verifification 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.

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