You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: July 20, 2024

Eliglustat tartrate - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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 two branded drugs marketed by Genzyme Corp, Aizant, Dr Reddys, Teva Pharms Usa Inc, and Upsher Smith Labs, and is included in five NDAs. 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 one hundred and sixty-two patent family members in forty-four countries.

There are six 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 Strength NDA ANDAs Submitted Submissiondate
CERDELGA Capsules eliglustat tartrate 84 mg 205494 6 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
Dr Reddys ELIGLUSTAT TARTRATE eliglustat tartrate CAPSULE;ORAL 212449-001 Aug 17, 2022 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Genzyme Corp CERDELGA eliglustat tartrate CAPSULE;ORAL 205494-001 Aug 19, 2014 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Genzyme Corp CERDELGA eliglustat tartrate CAPSULE;ORAL 205494-001 Aug 19, 2014 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for eliglustat tartrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genzyme Corp CERDELGA eliglustat tartrate CAPSULE;ORAL 205494-001 Aug 19, 2014 ⤷  Sign Up ⤷  Sign Up
Genzyme Corp CERDELGA eliglustat tartrate CAPSULE;ORAL 205494-001 Aug 19, 2014 ⤷  Sign Up ⤷  Sign Up
Genzyme Corp CERDELGA eliglustat tartrate CAPSULE;ORAL 205494-001 Aug 19, 2014 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for eliglustat tartrate

Country Patent Number Title Estimated Expiration
Taiwan I586663 ⤷  Sign Up
Denmark 1409467 ⤷  Sign Up
European Patent Office 2266968 Synthese d'UDP-glucose : inhibiteurs de la N-acylsphingosine glucosyl transferase (Synthesis of UDP-glucose: N-acylsphingosine glucosyltransferase inhibitors) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for eliglustat tartrate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1409467 CR 2015 00035 Denmark ⤷  Sign Up PRODUCT NAME: ELIGLUSTAT, EVENTUELT I FORM AF ET FYSIOLOGISK ACCEPTABELT SALT, HERUNDER ELIGLUSTAT (SOM TARTRAT); REG. NO/DATE: EU/1/14/974 20150119
1409467 132016000023075 Italy ⤷  Sign Up PRODUCT NAME: ELIGLUSTAT, OPZIONALMENTE NELLA FORMA DI UN SALE FARMACOLOGICAMENTE ACCETTABILE(CERDELGA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/974, 20150119
1409467 244 4-2015 Slovakia ⤷  Sign Up 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

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.