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, 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
Aizant	ELIGLUSTAT TARTRATE	eliglustat tartrate	CAPSULE;ORAL	212463-001	Sep 8, 2021	AB	RX	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		⤷ 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
Dr Reddys	ELIGLUSTAT TARTRATE	eliglustat tartrate	CAPSULE;ORAL	212449-001	Aug 17, 2022		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ 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
Apotex	ELIGLUSTAT TARTRATE	eliglustat tartrate	CAPSULE;ORAL	212425-001	Jul 10, 2024	AB	RX	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
>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
Argentina	079152	INHIBIDORES DE GLUCOSILCERAMIDA SINTASA	⤷ Sign Up
Singapore	10201800136Q	AN AMORPHOUS AND A CRYSTALLINE FORM OF GENZ 112638 HEMITARTRATE AS INHIBITOR OF GLUCOSYLCERAMIDE SYNTHASE	⤷ Sign Up
Denmark	2796457		⤷ Sign Up
Poland	3599237		⤷ Sign Up
Brazil	122015016314	método para preparar um composto acíclico, método para preparar um composto amina, método de preparar um composto como esfingosina e método para preparar um composto como ceramida	⤷ Sign Up
European Patent Office	1409467	UN INHIBITEUR DE N-ACYLSPHINGOSINE GLYCOSYLTRANSFERASE (A N-ACYLSPHINGOSINE GLUCOSYLTRANSFERASE INHIBITOR)	⤷ Sign Up
China	105777707	作为葡糖神经酰胺合酶的抑制剂的无定型和结晶形式的Genz 112638半酒石酸盐 (An amorphous and a crystalline form of Genz 112638 hemitartrat as inhibitor of glucosylceramide synthase)	⤷ 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	37/2015	Austria	⤷ Sign Up	PRODUCT NAME: ELIGLUSTAT, OPTIONAL IN DER FORM EINES PHYSIOLOGISCH AKZEPTABLEN SALZES; REGISTRATION NO/DATE: EU/1/14/974 20150119
1409467	1590029-3	Sweden	⤷ Sign Up	PRODUCT NAME: ELIGLUSTAT, VALFRITT I FORM AV ETT FYSIOLOGISKT GODTAGBART SALT; REG. NO/DATE: EU/1/14/974 20150121
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	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	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	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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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.