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CERDELGA Drug Profile

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Cerdelga is a drug marketed by Genzyme Corp and is included in one NDA. It is available from one supplier. There are three patents protecting this drug.

This drug has thirty-five patent family members in fourteen countries.

The generic ingredient in CERDELGA is eliglustat tartrate. One supplier is listed for this compound. Additional details are available on the eliglustat tartrate profile page.

Summary for Tradename: CERDELGA

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Genzyme Corp
CERDELGA
eliglustat tartrate
CAPSULE;ORAL205494-001Aug 19, 2014RXYes6,916,802► subscribe ► subscribe
Genzyme Corp
CERDELGA
eliglustat tartrate
CAPSULE;ORAL205494-001Aug 19, 2014RXYes► subscribe► subscribe
Genzyme Corp
CERDELGA
eliglustat tartrate
CAPSULE;ORAL205494-001Aug 19, 2014RXYes7,615,573► subscribe ► subscribe
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Non-Orange Book Patents for Tradename: CERDELGA

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► subscribe
8,779,163Synthesis of UDP-Glucose: N-acylsphingosine glucosyl transferase inhibitors► subscribe
5,916,911 Amino ceramide--like compounds and therapeutic methods of use► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: CERDELGA

Country Document Number Estimated Expiration
Canada2453978► subscribe
Japan2003521479► subscribe
Japan5227348► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: CERDELGA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0150027 00161Estonia► subscribePRODUCT NAME: ELIGLUSTAAT;REG NO/DATE: EU/1/14/974 21.01.2015
717Luxembourg► subscribePRODUCT NAME: ELIGLUSTAT, EVENTUELLEMENT SOUS LA FORME D UN SEL PHYSIOLOGIQUEMENT ACCEPTABLE. FIRST REGISTRATION: 20150121
90029-3Sweden► subscribePRODUCT NAME: ELIGLUSTAT, VALFRITT I FORM AV ETT FYSIOLOGISKT GODTAGBART SALT; REG. NO/DATE: EU/1/14/974 20150121
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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.

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