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Last Updated: January 28, 2021

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CERDELGA Drug Profile

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When do Cerdelga patents expire, and what generic alternatives are available?

Cerdelga is a drug marketed by Genzyme Corp and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has forty-nine patent family members in fifteen countries.

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.

US ANDA Litigation and Generic Entry Outlook for Cerdelga

Cerdelga was eligible for patent challenges on August 19, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 26, 2026. This may change due to patent challenges or generic licensing.

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for CERDELGA
Drug Prices for CERDELGA

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Generic Entry Opportunity Date for CERDELGA
Generic Entry Date for CERDELGA*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Recent Clinical Trials for CERDELGA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Taiwan University HospitalN/A
SanofiN/A
SanofiPhase 3

See all CERDELGA clinical trials

Paragraph IV (Patent) Challenges for CERDELGA
Tradename Dosage Ingredient NDA Submissiondate
CERDELGA CAPSULE;ORAL eliglustat tartrate 205494 2018-08-20

US Patents and Regulatory Information for CERDELGA

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 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Genzyme Corp CERDELGA eliglustat tartrate CAPSULE;ORAL 205494-001 Aug 19, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Genzyme Corp CERDELGA eliglustat tartrate CAPSULE;ORAL 205494-001 Aug 19, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Genzyme Corp CERDELGA eliglustat tartrate CAPSULE;ORAL 205494-001 Aug 19, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Genzyme Corp CERDELGA eliglustat tartrate CAPSULE;ORAL 205494-001 Aug 19, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for CERDELGA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1409467 1590029-3 Sweden   Start Trial PRODUCT NAME: ELIGLUSTAT, VALFRITT I FORM AV ETT FYSIOLOGISKT GODTAGBART SALT; REG. NO/DATE: EU/1/14/974 20150121
1409467 92717 Luxembourg   Start Trial PRODUCT NAME: ELIGLUSTAT, EVENTUELLEMENT SOUS LA FORME D UN SEL PHYSIOLOGIQUEMENT ACCEPTABLE. FIRST REGISTRATION: 20150121
1409467 15C0036 France   Start Trial PRODUCT NAME: ELIGLUSTAT,EVENTUELLEMENT SOUS FORME D'UN SEL PHYSIOLOGIQUEMENT ACCEPTABLE; REGISTRATION NO/DATE: EU/1/14/974 20150119
1409467 CR 2015 00035 Denmark   Start Trial PRODUCT NAME: ELIGLUSTAT, EVENTUELT I FORM AF ET FYSIOLOGISK ACCEPTABELT SALT, HERUNDER ELIGLUSTAT (SOM TARTRAT); REG. NO/DATE: EU/1/14/974 20150119
1409467 122015000051 Germany   Start Trial PRODUCT NAME: ELIGLUSTAT; REGISTRATION NO/DATE: EU/1/14/974 20150119
1409467 587 Finland   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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