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Last Updated: May 8, 2024

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, 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-one 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:	161
US Patents:	4
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	44
Clinical Trials:	6
Patent Applications:	176
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
Genzyme, a Sanofi Company	Phase 1
Sanofi	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	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial		Y		⤷ Try a Trial
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Upsher Smith Labs	ELIGLUSTAT TARTRATE	eliglustat tartrate	CAPSULE;ORAL	212420-001	May 2, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Teva Pharms Usa Inc	ELIGLUSTAT TARTRATE	eliglustat tartrate	CAPSULE;ORAL	212474-001	Dec 27, 2021		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Aizant	ELIGLUSTAT TARTRATE	eliglustat tartrate	CAPSULE;ORAL	212463-001	Sep 8, 2021	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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	⤷ Try a Trial	⤷ Try a Trial
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014	⤷ Try a Trial	⤷ Try a Trial
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014	⤷ Try a Trial	⤷ Try a Trial
>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
Dominican Republic	P2012000141	UNA FORMA AMORFA Y UNA CRISTALINA DE HEMITARTRATO GENZ 112638 COMO INHIBIDOR DE GLUCOSILCERAMIDA SINTASA	⤷ Try a Trial
Montenegro	02477	GENZ 112638 ZA LEČENJE GOŠEOVE ILI FABRIJEVE BOLESTI U KOMBINACIONOJ TERAPIJI (GENZ 112638 FOR TREATING GAUCHER OR FABRY DISEASE IN COMBINATION THERAPY)	⤷ Try a Trial
Canada	3083663	METHODES DE TRAITEMENT DE LA MALADIE DE GAUCHER (METHODS FOR TREATING GAUCHER DISEASE)	⤷ Try a Trial
Denmark	2504332		⤷ Try a Trial
China	111479591	治疗戈谢病的方法 (METHODS FOR TREATING GAUCHER DISEASE)	⤷ Try a Trial
European Patent Office	2266968	Synthese d'UDP-glucose : inhibiteurs de la N-acylsphingosine glucosyl transferase (Synthesis of UDP-glucose: N-acylsphingosine glucosyltransferase inhibitors)	⤷ Try a Trial
Argentina	121611	INHIBIDORES DE GLUCOSILCERAMIDA SINTASA	⤷ Try a Trial
>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	92717	Luxembourg	⤷ Try a Trial	PRODUCT NAME: ELIGLUSTAT, EVENTUELLEMENT SOUS LA FORME D UN SEL PHYSIOLOGIQUEMENT ACCEPTABLE. FIRST REGISTRATION: 20150121
1409467	C20150027 00161	Estonia	⤷ Try a Trial	PRODUCT NAME: ELIGLUSTAAT;REG NO/DATE: EU/1/14/974 21.01.2015
1409467	1590029-3	Sweden	⤷ Try a Trial	PRODUCT NAME: ELIGLUSTAT, VALFRITT I FORM AV ETT FYSIOLOGISKT GODTAGBART SALT; REG. NO/DATE: EU/1/14/974 20150121
1409467	C300738	Netherlands	⤷ Try a Trial	PRODUCT NAME: ELIGLUSTAT, OF FYSIOLOGISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/14/974 20150119
1409467	132016000023075	Italy	⤷ Try a Trial	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	⤷ Try a Trial	PRODUCT NAME: ELIGLUSTAT; REGISTRATION NO/DATE: EU/1/14/974 20150119
1409467	15C0036	France	⤷ Try a Trial	PRODUCT NAME: ELIGLUSTAT,EVENTUELLEMENT SOUS FORME D'UN SEL PHYSIOLOGIQUEMENT ACCEPTABLE; 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.