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Last Updated: December 14, 2019

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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 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

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

See all eliglustat tartrate clinical trials

Recent Litigation for eliglustat tartrate

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District Court Litigation
Case NameDate
GENZYME CORP. v. DR. REDDYS LABORATORIES, INC.2018-11-21
Genzyme Corp. v. Cipla Limited2018-11-20
Genzyme Corp. v. Apotex Corp.2018-11-14

See all eliglustat tartrate litigation

Synonyms for eliglustat tartrate
1000191-50-3
928659-70-5
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
Cerdelga (TN)
CHEBI:83353
CS-5423
D09894
DTXSID50239166
Eliglustat (hemitartrate)
Eliglustat (Tartrate)
eliglustat hemitartrate
Eliglustat hemitartrate(Genz-99067)
eliglustat L-tartrate
Eliglustat tartrate (JAN/USAN)
Eliglustat tartrate [USAN]
Genz 112638
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)
SB16832
UNII-N0493335P3
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   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 92717 Luxembourg   Start Trial PRODUCT NAME: ELIGLUSTAT, EVENTUELLEMENT SOUS LA FORME D UN SEL PHYSIOLOGIQUEMENT ACCEPTABLE. FIRST REGISTRATION: 20150121
1409467 C20150027 00161 Estonia   Start Trial PRODUCT NAME: ELIGLUSTAAT;REG NO/DATE: EU/1/14/974 21.01.2015
1409467 244 4-2015 Slovakia   Start Trial PRODUCT NAME: ELIGLUSTAT (VO FORME TARTRATU); REGISTRATION NO/DATE: EU/1/14/974 20150121
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.