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Last Updated: October 28, 2020

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Eliglustat tartrate - Generic Drug Details

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What are the generic drug sources for eliglustat tartrate and what is the scope of freedom to operate?

Eliglustat tartrate is the generic ingredient in one branded drug marketed by Genzyme Corp and is included in one NDA. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Eliglustat tartrate has forty-nine patent family members in fifteen countries.

There are eight drug master file entries for eliglustat tartrate. One supplier is listed for this compound.

Recent Clinical Trials for eliglustat tartrate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
SanofiPhase 1
Genzyme, a Sanofi CompanyPhase 1
Genzyme, a Sanofi CompanyPhase 3

See all eliglustat tartrate clinical trials

Paragraph IV (Patent) Challenges for ELIGLUSTAT TARTRATE
Tradename Dosage Ingredient NDA Submissiondate
CERDELGA CAPSULE;ORAL eliglustat tartrate 205494 2018-08-20

US Patents and Regulatory Information for eliglustat tartrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Genzyme Corp CERDELGA eliglustat tartrate CAPSULE;ORAL 205494-001 Aug 19, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Genzyme Corp CERDELGA eliglustat tartrate CAPSULE;ORAL 205494-001 Aug 19, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Genzyme Corp CERDELGA eliglustat tartrate CAPSULE;ORAL 205494-001 Aug 19, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Genzyme Corp CERDELGA eliglustat tartrate CAPSULE;ORAL 205494-001 Aug 19, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Genzyme Corp CERDELGA eliglustat tartrate CAPSULE;ORAL 205494-001 Aug 19, 2014 RX Yes Yes   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

Supplementary Protection Certificates for eliglustat tartrate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1409467 122015000051 Germany   Start Trial PRODUCT NAME: ELIGLUSTAT; REGISTRATION NO/DATE: EU/1/14/974 20150119
1409467 92717 Luxembourg   Start Trial PRODUCT NAME: ELIGLUSTAT, EVENTUELLEMENT SOUS LA FORME D UN SEL PHYSIOLOGIQUEMENT ACCEPTABLE. FIRST REGISTRATION: 20150121
1409467 CR 2015 00035 Denmark   Start Trial PRODUCT NAME: ELIGLUSTAT, EVENTUELT I FORM AF ET FYSIOLOGISK ACCEPTABELT SALT, HERUNDER ELIGLUSTAT (SOM TARTRAT); REG. NO/DATE: EU/1/14/974 20150119
1409467 C20150027 00161 Estonia   Start Trial PRODUCT NAME: ELIGLUSTAAT;REG NO/DATE: EU/1/14/974 21.01.2015
1409467 2015/027 Ireland   Start Trial PRODUCT NAME: ELIGLUSTAT, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/14/974 20150119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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