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Last Updated: May 20, 2022

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 six patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and sixty-three 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.

Drug patent expirations by year for CERDELGA
Drug Prices for CERDELGA

See drug prices for CERDELGA

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 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 eight US patents.

Patents protecting CERDELGA

Methods for treating Gaucher disease
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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)

Amino ceramide-like compounds and therapeutic methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF GAUCHER DISEASE TYPE 1

Synthesis of UDP-glucose: N-acylsphingosine glucosyltransferase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Amino ceramide-like compounds and therapeutic methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Synthesis of UDP-glucose: N-acylsphingosine glucosyltransferase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF GAUCHER DISEASE TYPE 1

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Genzyme Corp CERDELGA eliglustat tartrate CAPSULE;ORAL 205494-001 Aug 19, 2014 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Genzyme Corp CERDELGA eliglustat tartrate CAPSULE;ORAL 205494-001 Aug 19, 2014 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Genzyme Corp CERDELGA eliglustat tartrate CAPSULE;ORAL 205494-001 Aug 19, 2014 See Plans and Pricing See Plans and Pricing
Genzyme Corp CERDELGA eliglustat tartrate CAPSULE;ORAL 205494-001 Aug 19, 2014 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for CERDELGA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1409467 37/2015 Austria See Plans and Pricing PRODUCT NAME: ELIGLUSTAT, OPTIONAL IN DER FORM EINES PHYSIOLOGISCH AKZEPTABLEN SALZES; REGISTRATION NO/DATE: EU/1/14/974 20150119
1409467 15C0036 France See Plans and Pricing PRODUCT NAME: ELIGLUSTAT,EVENTUELLEMENT SOUS FORME D'UN SEL PHYSIOLOGIQUEMENT ACCEPTABLE; REGISTRATION NO/DATE: EU/1/14/974 20150119
1409467 122015000051 Germany See Plans and Pricing PRODUCT NAME: ELIGLUSTAT; REGISTRATION NO/DATE: EU/1/14/974 20150119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Express Scripts
McKinsey
Harvard Business School
Johnson and Johnson
AstraZeneca

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