Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Teva
US Department of Justice
Fish and Richardson
Chinese Patent Office
Merck
AstraZeneca
QuintilesIMS
UBS

Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205494

« Back to Dashboard

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 three patents protecting this drug. Additional details are available on the CERDELGA profile page.

The generic ingredient in CERDELGA is eliglustat tartrate. There are six 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:3
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 N 58468-0220-2
CERDELGA eliglustat tartrate CAPSULE;ORAL 205494 NDA Genzyme Corporation 58468-0220 N 58468-0220-1

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?Delist Request?
Patented Use:TREATMENT OF GAUCHER DISEASE TYPE 1

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Chubb
Covington
Johnson and Johnson
McKinsey
Dow
Fish and Richardson
Julphar
Daiichi Sankyo

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 verifification 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.