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Generated: November 19, 2018

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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
Generic Entry Opportunity Date for 205494
Generic Entry Date for 205494*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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:RXDosage:CAPSULE;ORALStrengthEQ 84MG BASE
Approval Date:Aug 19, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 19, 2021
Regulatory Exclusivity Use:LONG-TERM TREATMENT OF ADULT PATIENTS WITH GAUCHER DISEASE TYPE 1 WHO ARE CYP2D6 EXTENSIVE METABOLIZERS (EMS), INTERMEDIATE METABOLIZERS (IMS), OR POOR METABOLIZERS (PMS) AS DETECTED BY AN FDA-CLEARED TEST.
Regulatory Exclusivity Expiration:Aug 19, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Try a Free TrialPatent Expiration:Apr 29, 2022Product Flag?Substance Flag?YDelist Request?
Patented Use:TREATMENT OF GAUCHER DISEASE TYPE 1

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