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Last Updated: November 27, 2022

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 two branded drugs marketed by Genzyme Corp, Aizant, Dr Reddys, and Teva Pharms Usa Inc, and is included in four NDAs. There are six 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-five 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
Genzyme, a Sanofi CompanyPhase 1
SanofiPhase 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
Genzyme Corp CERDELGA eliglustat tartrate CAPSULE;ORAL 205494-001 Aug 19, 2014 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Aizant ELIGLUSTAT TARTRATE eliglustat tartrate CAPSULE;ORAL 212463-001 Sep 8, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Genzyme Corp CERDELGA eliglustat tartrate CAPSULE;ORAL 205494-001 Aug 19, 2014 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Genzyme Corp CERDELGA eliglustat tartrate CAPSULE;ORAL 205494-001 Aug 19, 2014 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Genzyme Corp CERDELGA eliglustat tartrate CAPSULE;ORAL 205494-001 Aug 19, 2014 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Teva Pharms Usa Inc ELIGLUSTAT TARTRATE eliglustat tartrate CAPSULE;ORAL 212474-001 Dec 27, 2021 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Genzyme Corp CERDELGA eliglustat tartrate CAPSULE;ORAL 205494-001 Aug 19, 2014 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Genzyme Corp CERDELGA eliglustat tartrate CAPSULE;ORAL 205494-001 Aug 19, 2014 See Plans and Pricing See Plans and Pricing
Genzyme Corp CERDELGA eliglustat tartrate CAPSULE;ORAL 205494-001 Aug 19, 2014 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for eliglustat tartrate

Country Patent Number Title Estimated Expiration
Poland 2796457 See Plans and Pricing
Singapore 10201407881W AN AMORPHOUS AND A CRYSTALLINE FORM OF GENZ 112638 HEMITARTRATE AS INHIBITOR OF GLUCOSYLCERAMIDE SYNTHASE See Plans and Pricing
Nicaragua 201200096 INHIBIDORES DE GLUCOSILCERAMIDA SINTASA See Plans and Pricing
Luxembourg 92717 See Plans and Pricing
European Patent Office 3599237 COMPOSITION PHARMACEUTIQUE DU INHIBITEUR DE LA GLUCOSYLCÉRAMIDE SYNTHASE ÉLIGLUSTAT POUR LE TRAITEMENT DE LA MALADIE DE GAUCHER, COMPRENANT AJUSTER LA DOSE THÉRAPEUTIQUE INDIVIDUELLE AU MÉTABOLISME DU P-450 DU PATIENT (PHARMACEUTICAL COMPOSITION OF THE GLUCOSYLCERAMIDE SYNTHASE INHIBITOR ELIGLUSTAT FOR THE TREATMENT GAUCHER'S DISEASE COMPRISING ADJUSTING THE INDIVIDUAL THERAPEUTICAL DOSE TO THE P450 METABOLISM OF THE PATIENT) See Plans and Pricing
World Intellectual Property Organization (WIPO) 0104108 See Plans and Pricing
Spain 2395122 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for eliglustat tartrate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1409467 37/2015 Austria See Plans and Pricing PRODUCT NAME: ELIGLUSTAT, OPTIONAL IN DER FORM EINES PHYSIOLOGISCH AKZEPTABLEN SALZES; REGISTRATION NO/DATE: EU/1/14/974 20150119
1409467 2015/027 Ireland See Plans and Pricing PRODUCT NAME: ELIGLUSTAT, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/14/974 20150119
1409467 1590029-3 Sweden See Plans and Pricing PRODUCT NAME: ELIGLUSTAT, VALFRITT I FORM AV ETT FYSIOLOGISKT GODTAGBART SALT; REG. NO/DATE: EU/1/14/974 20150121
1409467 C20150027 00161 Estonia See Plans and Pricing PRODUCT NAME: ELIGLUSTAAT;REG NO/DATE: EU/1/14/974 21.01.2015
1409467 244 4-2015 Slovakia See Plans and Pricing PRODUCT NAME: ELIGLUSTAT (VO FORME TARTRATU); REGISTRATION NO/DATE: EU/1/14/974 20150121
1409467 15C0036 France See Plans and Pricing PRODUCT NAME: ELIGLUSTAT,EVENTUELLEMENT SOUS FORME D'UN SEL PHYSIOLOGIQUEMENT ACCEPTABLE; REGISTRATION NO/DATE: EU/1/14/974 20150119
1409467 CR 2015 00035 Denmark See Plans and Pricing PRODUCT NAME: ELIGLUSTAT, EVENTUELT I FORM AF ET FYSIOLOGISK ACCEPTABELT SALT, HERUNDER ELIGLUSTAT (SOM TARTRAT); REG. NO/DATE: EU/1/14/974 20150119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
Boehringer Ingelheim
Moodys
Dow
McKesson
Express Scripts

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