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Ranolazine - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for ranolazine?

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.

This ingredient 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 is one tentative approval for this compound.

Summary for Generic Name: ranolazine

Tradenames:2
Patents:11
Applicants:2
NDAs:2
Drug Master File Entries: see list15
Suppliers / Packagers: see list4
Bulk Api Vendors: see list78
Clinical Trials: see list16
Patent Applications: see list802
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. Form Dosage
► Subscribe► SubscribeTABLET, EXTENDED RELEASE;ORAL500MG
► Subscribe► SubscribeTABLET, EXTENDED RELEASE;ORAL1000MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead
RANEXA
ranolazine
TABLET, EXTENDED RELEASE;ORAL021526-001Feb 12, 2007RXYesYes6,864,258► Subscribe ► Subscribe
Gilead
RANEXA
ranolazine
TABLET, EXTENDED RELEASE;ORAL021526-002Jan 27, 2006RXYesNo6,617,328► SubscribeY ► Subscribe
Gilead
RANEXA
ranolazine
TABLET, EXTENDED RELEASE;ORAL021526-002Jan 27, 2006RXYesNo6,620,814► Subscribe ► Subscribe
Gilead
RANEXA
ranolazine
TABLET, EXTENDED RELEASE;ORAL021526-002Jan 27, 2006RXYesNo6,369,062► SubscribeY ► Subscribe
Gilead
RANEXA
ranolazine
TABLET, EXTENDED RELEASE;ORAL021526-002Jan 27, 2006RXYesNo6,525,057► 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;ORAL021526-001Feb 12, 20074,567,264► Subscribe
Gilead
RANEXA
ranolazine
TABLET, EXTENDED RELEASE;ORAL021526-002Jan 27, 20064,567,264► Subscribe
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International Patent Family for Ingredient: ranolazine

Country Document Number Estimated Expiration
New Zealand521292► Subscribe
Israel141892► Subscribe
Israel175371► Subscribe
Norway20024270► Subscribe
Brazil9913626► 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
1Finland► Subscribe
2008017,C1109558Lithuania► SubscribePRODUCT NAME: RANOLAZINUM; REGISTRATION NO/DATE: EU/1/08/462/001 - EU/1/08/462/006, 0080709
504Luxembourg► Subscribe91504, EXPIRES: 20230709
2008017Lithuania► SubscribePRODUCT NAME: RANOLAZINUM; REGISTRATION NO/DATE: EU/1/08/462/001 - EU/1/08/462/006 20080709
08/034Ireland► SubscribePRODUCT NAME: RANOLAZINE OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/08/462/001 20080709
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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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