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Generated: November 19, 2018

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Eliglustat tartrate - Generic Drug Details

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What are the generic sources for eliglustat tartrate and what is the scope of eliglustat tartrate 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.

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

Summary for eliglustat tartrate
Synonyms for eliglustat tartrate
104138-64-9
928659-70-5
AK310487
AKOS027321062
bis(N-((1R,2R)-2-(2,3-Dihydro-1,4-benzodioxin-6-yl)-2-hydroxy-1-(pyrrolidin-1- ylmethyl)ethyl)octanamide) (2R,3R)-2,3-dihydroxybutanedioate
bis{1-[(2R,3R)-3-(2,3-dihydro-1,4-benzodioxin-6-yl)-3-hydroxy-2-(octanoylamino)propyl]pyrrolidinium} (2R,3R)-2,3-dihydroxysuccinate
bis{N-[(1R,2R)-1-(2,3-dihydro-1,4-benzodioxin-6-yl)-1-hydroxy-3-(pyrrolidin-1-yl)propan-2-yl]octanamide} (2R,3R)-2,3-dihydroxysuccinic acid
Cerdelga (TN)
CHEBI:83353
CS-5423
D09894
D0J8IJ
DTXSID50239166
Eliglustat (hemitartrate)
Eliglustat (Tartrate)
eliglustat hemitartrate
Eliglustat hemitartrate(Genz-99067)
eliglustat L-tartrate
Eliglustat tartrate (JAN/USAN)
Eliglustat tartrate [USAN]
Fabrazyme (TN)
GENZ-112638
HY-14885A
N0493335P3
Octanamide, N-((1R,2R)-2-(2,3-dihydro-1,4-benzodioxin-6-yl)-2-hydroxy-1-(1- pyrrolidinylmethyl)ethyl)-, (2R,3R)-2,3-dihydroxybutanedioate (2:1)
UNII-N0493335P3

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

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Supplementary Protection Certificates for eliglustat tartrate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0150027 00161 Estonia ➤ Try a Free Trial PRODUCT NAME: ELIGLUSTAAT;REG NO/DATE: EU/1/14/974 21.01.2015
2015 00035 Denmark ➤ Try a Free Trial PRODUCT NAME: ELIGLUSTAT, EVENTUELT I FORM AF ET FYSIOLOGISK ACCEPTABELT SALT, HERUNDER ELIGLUSTAT (SOM TARTRAT); REG. NO/DATE: EU/1/14/974 20150119
C0036 France ➤ Try a Free Trial PRODUCT NAME: ELIGLUSTAT,EVENTUELLEMENT SOUS FORME D'UN SEL PHYSIOLOGIQUEMENT ACCEPTABLE; REGISTRATION NO/DATE: EU/1/14/974 20150119
2015000051 Germany ➤ Try a Free Trial PRODUCT NAME: ELIGLUSTAT, GGF. IN FORM EINES PHYSIOLOGISCH ANNEHMBAREN SALZES; REGISTRATION NO/DATE: EU/1/14/974 20150119
15/027 Ireland ➤ Try a Free Trial PRODUCT NAME: ELIGLUSTAT, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/14/974 20150119
/2015 Austria ➤ Try a Free Trial PRODUCT NAME: ELIGLUSTAT, OPTIONAL IN DER FORM EINES PHYSIOLOGISCH AKZEPTABLEN SALZES; REGISTRATION NO/DATE: EU/1/14/974 20150119
4 4-2015 Slovakia ➤ Try a Free Trial PRODUCT NAME: ELIGLUSTAT (VO FORME TARTRATU); REGISTRATION NO/DATE: EU/1/14/974 20150121
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Dow
Mallinckrodt
Farmers Insurance
Express Scripts
QuintilesIMS
US Army
AstraZeneca
Fuji

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