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Last Updated: April 22, 2024

CERDELGA Drug Patent 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 one hundred and sixty-one patent family members in forty-four 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.

DrugPatentWatch® Litigation and Generic Entry Outlook for Cerdelga

A generic version of CERDELGA was approved as eliglustat tartrate by AIZANT on September 8th, 2021.

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Drug patent expirations by year for CERDELGA
Drug Prices for CERDELGA

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Recent Clinical Trials for CERDELGA

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

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Paragraph IV (Patent) Challenges for CERDELGA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
CERDELGA Capsules eliglustat tartrate 84 mg 205494 6 2018-08-20

US Patents and Regulatory Information for CERDELGA

CERDELGA is protected by six US patents.

Patents protecting CERDELGA

Methods for treating Gaucher disease
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: LONG-TERM TREATMENT OF ADULTS WITH GAUCHER DISEASE TYPE 1 WHO ARE CYP2D6 EXTENSIVE METABOLIZERS WITH MODERATE TO SEVERE RENAL IMPAIRMENT

Methods for treating Gaucher disease
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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

Amorphous and a crystalline form of genz 112638 hemitartrate as inhibitor of glucosylceramide synthase
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: LONG-TERM TREATMENT OF ADULTS WITH GAUCHER DISEASE TYPE 1 WHO ARE CYP2D6 POOR METABOLIZERS WITH 84 MG ONCE DAILY OF ELIGLUSTAT (EQUIVALENT TO 100 MG OF ELIGLUSTAT TARTRATE)

Amorphous and a crystalline form of genz 112638 hemitartrate as inhibitor of glucosylceramide synthase
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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)


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Synthesis of UDP-glucose: N-acylsphingosine glucosyltransferase inhibitors
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Patent Expiration: ⤷  Try a Trial

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

Expired US Patents for CERDELGA

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

International Patents for CERDELGA

See the table below for patents covering CERDELGA around the world.

Country Patent Number Title Estimated Expiration
Canada 2453978 SYNTHESE D'INHIBITEURS DE L'UDP-GLUCOSE : N-ACYLSPHINGOSINE GLYCOSYLTRANSFERASE (SYNTHESIS OF UDP-GLUCOSE: N-ACYLSPHINGOSINE GLUCOSYLTRANSFERASE INHIBITORS) ⤷  Try a Trial
Denmark 2266968 ⤷  Try a Trial
Portugal 2796457 ⤷  Try a Trial
Slovenia 2504332 ⤷  Try a Trial
South Korea 102073207 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CERDELGA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1409467 2015/027 Ireland ⤷  Try a Trial PRODUCT NAME: ELIGLUSTAT, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/14/974 20150119
1409467 C300738 Netherlands ⤷  Try a Trial PRODUCT NAME: ELIGLUSTAT, OF FYSIOLOGISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/14/974 20150119
1409467 1590029-3 Sweden ⤷  Try a Trial PRODUCT NAME: ELIGLUSTAT, VALFRITT I FORM AV ETT FYSIOLOGISKT GODTAGBART SALT; REG. NO/DATE: EU/1/14/974 20150121
1409467 587 Finland ⤷  Try a Trial
1409467 244 4-2015 Slovakia ⤷  Try a Trial PRODUCT NAME: ELIGLUSTAT (VO FORME TARTRATU); REGISTRATION NO/DATE: EU/1/14/974 20150121
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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