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Generated: June 19, 2018

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Eliglustat tartrate - Generic Drug Details

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What are the generic sources for eliglustat tartrate and what is the scope of eliglustat tartrate freedom to operate?

Eliglustat tartrate
is the generic ingredient in one branded drug marketed by Genzyme Corp and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Eliglustat tartrate has forty-six patent family members in fifteen countries.

There are six drug master file entries for eliglustat tartrate. One supplier is listed for this compound.
Summary for eliglustat tartrate
International Patents:46
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 6
Suppliers / Packagers: 1
Bulk Api Vendors: 15
Clinical Trials: 146
DailyMed Link:eliglustat tartrate at DailyMed
Synonyms for eliglustat tartrate
104138-64-9
928659-70-5
AK310487
AKOS027321062
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
D0J8IJ
DTXSID50239166
Eliglustat (hemitartrate)
Eliglustat (Tartrate)
eliglustat hemitartrate
Eliglustat hemitartrate(Genz-99067)
eliglustat L-tartrate
Eliglustat tartrate (JAN/USAN)
Eliglustat tartrate [USAN]
Fabrazyme (TN)
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)
UNII-N0493335P3

US Patents and Regulatory Information for eliglustat tartrate

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

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Non-Orange Book US Patents for eliglustat tartrate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,855,830 Synthesis of UDP-glucose: N-acylsphingosine glucosyltransferase inhibitors ➤ Sign Up
7,265,228 Synthesis of UDP-glucose: N-acylsphingosine glucosyltransferase inhibitors ➤ Sign Up
7,763,738 Synthesis of UDP-glucose: N-acylsphingosine glucosyltransferase inhibitors ➤ Sign Up
8,138,353 Synthesis of UDP-glucose: N-acylsphingosine glucosyltransferase inhibitors ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for eliglustat tartrate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0150027 00161 Estonia ➤ Sign Up PRODUCT NAME: ELIGLUSTAAT;REG NO/DATE: EU/1/14/974 21.01.2015
2015000051 Germany ➤ Sign Up PRODUCT NAME: ELIGLUSTAT, GGF. IN FORM EINES PHYSIOLOGISCH ANNEHMBAREN SALZES; REGISTRATION NO/DATE: EU/1/14/974 20150119
/2015 Austria ➤ Sign Up PRODUCT NAME: ELIGLUSTAT, OPTIONAL IN DER FORM EINES PHYSIOLOGISCH AKZEPTABLEN SALZES; REGISTRATION NO/DATE: EU/1/14/974 20150119
00738 Netherlands ➤ Sign Up PRODUCT NAME: ELIGLUSTAT, OF FYSIOLOGISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/14/974 20150119
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Farmers Insurance
Accenture
Healthtrust
McKesson
Cipla
Chubb
Chinese Patent Office
Dow

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.