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
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
Teva Pharms Usa Inc	ELIGLUSTAT TARTRATE	eliglustat tartrate	CAPSULE;ORAL	212474-001	Dec 27, 2021		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Upsher Smith Labs	ELIGLUSTAT TARTRATE	eliglustat tartrate	CAPSULE;ORAL	212420-001	May 2, 2023	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
Slovenia	3133070		⤷ Sign Up
South Korea	102073207		⤷ Sign Up
Japan	2017075151	ＵＤＰ−グルコース：Ｎ−アシルスフィンゴシングルコシルトランスフェラーゼインヒビターの合成 (SYNTHESIS OF UDP-GLUCOSE:N-ACYLSPHINGOSINE GLUCOSYL TRANSFERASE INHIBITORS)	⤷ Sign Up
Dominican Republic	P2012000141	UNA FORMA AMORFA Y UNA CRISTALINA DE HEMITARTRATO 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	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	92717	Luxembourg	⤷ Sign Up	PRODUCT NAME: ELIGLUSTAT, EVENTUELLEMENT SOUS LA FORME D UN SEL PHYSIOLOGIQUEMENT ACCEPTABLE. FIRST REGISTRATION: 20150121
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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