Details for New Drug Application (NDA): 205494

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NDA 205494 describes CERDELGA, which is a drug marketed by Genzyme Corp and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the CERDELGA profile page.

The generic ingredient in CERDELGA is eliglustat tartrate. There are eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the eliglustat tartrate profile page.

Summary for 205494

Tradename:	CERDELGA
Applicant:	Genzyme Corp
Ingredient:	eliglustat tartrate
Patents:	4

Pharmacology for NDA: 205494

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

Suppliers and Packaging for NDA: 205494

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494	NDA	Genzyme Corporation	58468-0220	58468-0220-1	4 BLISTER PACK in 1 CARTON (58468-0220-1) / 14 CAPSULE in 1 BLISTER PACK
CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494	NDA	Genzyme Corporation	58468-0220	58468-0220-2	1 BLISTER PACK in 1 CARTON (58468-0220-2) / 14 CAPSULE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 84MG BASE
Approval Date:	Aug 19, 2014	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Dec 13, 2038	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	LONG-TERM TREATMENT OF ADULTS WITH GAUCHER DISEASE TYPE 1 WHO ARE CYP2D6 EXTENSIVE METABOLIZERS WITH MILD HEPATIC IMPAIRMENT AND ARE CONCURRENTLY TAKING A STRONG OR MODERATE CYP3A INHIBITOR
Patent:	⤷ Sign Up	Patent Expiration:	Dec 13, 2038	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	LONG-TERM TREATMENT OF ADULTS WITH GAUCHER DISEASE TYPE 1 WHO ARE CYP2D6 EXTENSIVE METABOLIZERS WITH MODERATE TO SEVERE RENAL IMPAIRMENT
Patent:	⤷ Sign Up	Patent Expiration:	Jan 31, 2031	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	LONG-TERM TREATMENT OF ADULTS WITH GAUCHER DISEASE TYPE 1 WHO ARE CYP2D6 EXTENSIVE OR INTERMEDIATE METABOLIZERS WITH 84 MG TWICE PER DAY OF ELIGLUSTAT (EQUIVALENT TO 100 MG OF ELIGLUSTAT TARTRATE TWICE PER DAY)

Expired US Patents for NDA 205494

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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

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