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Last Updated: June 3, 2020

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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
SanofiN/A
National Taiwan University HospitalN/A
SanofiPhase 3

See all CERDELGA clinical trials

Recent Litigation for CERDELGA

Identify potential future generic entrants

District Court Litigation
Case NameDate
GENZYME CORP. v. DR. REDDYS LABORATORIES, INC.2018-11-21
Genzyme Corp. v. Cipla Limited2018-11-20
Genzyme Corp. v. Apotex Corp.2018-11-14

See all CERDELGA litigation

Synonyms for CERDELGA
928659-70-5
bis(N-((1R,2R)-2-(2,3-Dihydro-1,4-benzodioxin-6-yl)-2-hydroxy-1-(pyrrolidin-1- ylmethyl)ethyl)octanamide) (2R,3R)-2,3-dihydroxybutanedioate
bis{1-[(2R,3R)-3-(2,3-dihydro-1,4-benzodioxin-6-yl)-3-hydroxy-2-(octanoylamino)propyl]pyrrolidinium} (2R,3R)-2,3-dihydroxysuccinate
bis{N-[(1R,2R)-1-(2,3-dihydro-1,4-benzodioxin-6-yl)-1-hydroxy-3-(pyrrolidin-1-yl)propan-2-yl]octanamide} (2R,3R)-2,3-dihydroxysuccinic acid
Cerdelga (TN)
CHEBI:83353
CS-5423
D09894
DTXSID50239166
Eliglustat (hemitartrate)
Eliglustat (Tartrate)
eliglustat hemitartrate
Eliglustat hemitartrate(Genz-99067)
eliglustat L-tartrate
Eliglustat tartrate
Eliglustat tartrate (JAN/USAN)
Eliglustat tartrate [USAN]
EX-A2301-1
Genz 112638
GENZ-112638
HY-14885A
N0493335P3
Octanamide, N-((1R,2R)-2-(2,3-dihydro-1,4-benzodioxin-6-yl)-2-hydroxy-1-(1- pyrrolidinylmethyl)ethyl)-, (2R,3R)-2,3-dihydroxybutanedioate (2:1)
Q27156779
SB16832
UNII-N0493335P3
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   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 Y   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 587 Finland   Start Trial
1409467 244 4-2015 Slovakia   Start 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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Serving leading biopharmaceutical companies globally:

McKesson
Express Scripts
McKinsey
Harvard Business School
Johnson and Johnson
AstraZeneca

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 verification 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.