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RANEXA Drug Profile

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Ranexa is a drug marketed by Gilead and is included in one NDA. It is available from four suppliers. There are ten patents protecting this drug.

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

The generic ingredient in RANEXA is ranolazine. There are twelve drug master file entries for this compound. Four suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the ranolazine profile page.

Summary for Tradename: RANEXA

Patents:10
Applicants:1
NDAs:1
Suppliers / Packagers: see list4

Clinical Trials for: RANEXA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead
RANEXA
ranolazine
TABLET, EXTENDED RELEASE;ORAL021526-001Feb 12, 2007RXYes6,303,607<disabled> <disabled>
Gilead
RANEXA
ranolazine
TABLET, EXTENDED RELEASE;ORAL021526-002Jan 27, 2006RXNo6,617,328<disabled>Y <disabled>
Gilead
RANEXA
ranolazine
TABLET, EXTENDED RELEASE;ORAL021526-001Feb 12, 2007RXYes6,864,258<disabled> <disabled>
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Expired Patents for Tradename: RANEXA

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead
RANEXA
ranolazine
TABLET, EXTENDED RELEASE;ORAL021526-002Jan 27, 20064,567,264<disabled>
Gilead
RANEXA
ranolazine
TABLET, EXTENDED RELEASE;ORAL021526-001Feb 12, 20074,567,264<disabled>
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International Patent Family for Tradename: RANEXA

Country Document Number Estimated Expiration
Norway2009005<disabled in preview>
Czech Republic20010880<disabled in preview>
Denmark1096937<disabled in preview>
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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: RANEXA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB08/058United Kingdom<disabled>PRODUCT NAME: RANOLAZINE OR A SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/08/462/001 - 006 20080714
2008017Lithuania<disabled>PRODUCT NAME: RANOLAZINUM; REGISTRATION NO/DATE: EU/1/08/462/001 - EU/1/08/462/006 20080709
1109558/01Switzerland<disabled>PRODUCT NAME: RANOLAZINE; REGISTRATION NO/DATE: SWISSMEDIC 60553 13.04.2010
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