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Last Updated: July 2, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021526


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NDA 021526 describes RANEXA, which is a drug marketed by Gilead and is included in one NDA. It is available from two suppliers. Additional details are available on the RANEXA profile page.

The generic ingredient in RANEXA is ranolazine. There are twenty-three drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the ranolazine profile page.
Summary for 021526
Tradename:RANEXA
Applicant:Gilead
Ingredient:ranolazine
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 021526
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526 NDA Aphena Pharma Solutions - Tennessee, LLC 43353-880 43353-880-83 3600 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43353-880-83)
RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526 NDA Gilead Sciences, Inc. 61958-1003 61958-1003-1 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (61958-1003-1)
Paragraph IV (Patent) Challenges for 021526
Tradename Dosage Ingredient NDA Submissiondate
RANEXA TABLET, EXTENDED RELEASE;ORAL ranolazine 021526 2010-05-17

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength1GM
Approval Date:Feb 12, 2007TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Jan 27, 2006TE:ABRLD:Yes

Expired US Patents for NDA 021526

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 021526-001 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

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