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Last Updated: March 29, 2024

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
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:ABRLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Dec 13, 2038Product 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:⤷  Try a TrialPatent Expiration:Dec 13, 2038Product 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:⤷  Try a TrialPatent Expiration:Jan 31, 2031Product 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

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

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