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 two branded drugs marketed by Genzyme Corp, Aizant, Apotex, Dr Reddys, Teva Pharms Usa Inc, and Upsher Smith Labs, and is included in six 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.

Summary for ELIGLUSTAT TARTRATE

International Patents:	162
US Patents:	4
Tradenames:	2
Applicants:	6
NDAs:	6
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	44
Clinical Trials:	6
Patent Applications:	137
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ELIGLUSTAT TARTRATE
DailyMed Link:	ELIGLUSTAT TARTRATE at DailyMed

Recent Clinical Trials for ELIGLUSTAT TARTRATE

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

Sponsor	Phase
Sanofi	Phase 1
Genzyme, a Sanofi Company	Phase 1
Genzyme, a Sanofi Company	Phase 3

See all ELIGLUSTAT TARTRATE clinical trials

Pharmacology for ELIGLUSTAT TARTRATE

Drug Class	Glucosylceramide Synthase Inhibitor
Mechanism of Action	Cytochrome P450 2D6 Inhibitors Glucosylceramide Synthase Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ELIGLUSTAT TARTRATE

A16AX	Various alimentary tract and metabolism products
A16A	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A	Alimentary tract and metabolism

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Upsher Smith Labs	ELIGLUSTAT TARTRATE	eliglustat tartrate	CAPSULE;ORAL	212420-001	May 2, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
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
Teva Pharms Usa Inc	ELIGLUSTAT TARTRATE	eliglustat tartrate	CAPSULE;ORAL	212474-001	Dec 27, 2021		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				⤷ Sign Up
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aizant	ELIGLUSTAT TARTRATE	eliglustat tartrate	CAPSULE;ORAL	212463-001	Sep 8, 2021	AB	RX	No	No	⤷ 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

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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

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Country	Patent Number	Title	Estimated Expiration
Cyprus	1113586		⤷ Sign Up
Hungary	E045784		⤷ Sign Up
Spain	2586947		⤷ Sign Up
South Korea	20200013105	글루코실세라마이드 신타아제의 억제제로서 ＧＥＮＺ 112638 헤미타르타르산염의 무정형 및 결정질 형태 (112638 AN AMORPHOUS AND A CRYSTALLINE FORM OF GENZ 112638 HEMITARTRATE AS INHIBITOR OF GLUCOSYLCERAMIDE SYNTHASE)	⤷ Sign Up
Cyprus	1113919		⤷ Sign Up
Japan	2021506789	ゴーシェ病を処置する方法	⤷ Sign Up
Peru	20171255	FORMA CRISTALINA Y AMORFA DE HEMITARTRATO DE GENZ 112638 COMO INHIBIDOR DE GLUCOSILCERAMIDA SINTASA	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ELIGLUSTAT TARTRATE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1409467	587	Finland	⤷ Sign Up
1409467	C20150027 00161	Estonia	⤷ Sign Up	PRODUCT NAME: ELIGLUSTAAT;REG NO/DATE: EU/1/14/974 21.01.2015
1409467	2015/027	Ireland	⤷ Sign Up	PRODUCT NAME: ELIGLUSTAT, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/14/974 20150119
1409467	15C0036	France	⤷ Sign Up	PRODUCT NAME: ELIGLUSTAT,EVENTUELLEMENT SOUS FORME D'UN SEL PHYSIOLOGIQUEMENT ACCEPTABLE; REGISTRATION NO/DATE: EU/1/14/974 20150119
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	122015000051	Germany	⤷ Sign Up	PRODUCT NAME: ELIGLUSTAT; REGISTRATION NO/DATE: EU/1/14/974 20150119
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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