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-two 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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Questions you can ask:
- What is the 5 year forecast for CERDELGA?
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Summary for CERDELGA
International Patents: | 162 |
US Patents: | 4 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 42 |
Clinical Trials: | 6 |
Patent Applications: | 56 |
Drug Prices: | Drug price information for CERDELGA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CERDELGA |
What excipients (inactive ingredients) are in CERDELGA? | CERDELGA excipients list |
DailyMed Link: | CERDELGA at DailyMed |
![CERDELGA drug patent expirations Drug patent expirations by year for CERDELGA](/p/graph/s/t/CERDELGA-patent-expirations.png)
![Drug Prices for CERDELGA](/p/graph/drug-price/CERDELGA.png)
Recent Clinical Trials for CERDELGA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Sanofi | N/A |
National Taiwan University Hospital | N/A |
Sanofi | Phase 3 |
Pharmacology for CERDELGA
Drug Class | Glucosylceramide Synthase Inhibitor |
Mechanism of Action | Cytochrome P450 2D6 Inhibitors Glucosylceramide Synthase Inhibitors P-Glycoprotein Inhibitors |
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Synthesis of UDP-glucose: N-acylsphingosine glucosyltransferase inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Genzyme Corp | CERDELGA | eliglustat tartrate | CAPSULE;ORAL | 205494-001 | Aug 19, 2014 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Genzyme Corp | CERDELGA | eliglustat tartrate | CAPSULE;ORAL | 205494-001 | Aug 19, 2014 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | |
Genzyme Corp | CERDELGA | eliglustat tartrate | CAPSULE;ORAL | 205494-001 | Aug 19, 2014 | AB | 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 |
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 | ⤷ Sign Up | ⤷ Sign Up |
Genzyme Corp | CERDELGA | eliglustat tartrate | CAPSULE;ORAL | 205494-001 | Aug 19, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Genzyme Corp | CERDELGA | eliglustat tartrate | CAPSULE;ORAL | 205494-001 | Aug 19, 2014 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
Malaysia | 192644 | AN AMORPHOUS AND A CRYSTALLINE FORM OF GENZ 112638 HEMITARTRATE AS INHIBITOR OF GLUCOSYLCERAMIDE SYNTHASE | ⤷ Sign Up |
Dominican Republic | P2016000250 | UNA FORMA AMORFA Y UNA CRISTALINA DE HEMITARTRATO GENZ 112638 COMO INHIBIDOR DE GLUCOSILCERAMIDA SINTASA | ⤷ Sign Up |
Portugal | 3599237 | ⤷ Sign Up | |
European Patent Office | 1409467 | UN INHIBITEUR DE N-ACYLSPHINGOSINE GLYCOSYLTRANSFERASE (A N-ACYLSPHINGOSINE GLUCOSYLTRANSFERASE INHIBITOR) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CERDELGA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1409467 | 1590029-3 | Sweden | ⤷ Sign Up | PRODUCT NAME: ELIGLUSTAT, VALFRITT I FORM AV ETT FYSIOLOGISKT GODTAGBART SALT; REG. NO/DATE: EU/1/14/974 20150121 |
1409467 | CR 2015 00035 | Denmark | ⤷ Sign Up | PRODUCT NAME: ELIGLUSTAT, EVENTUELT I FORM AF ET FYSIOLOGISK ACCEPTABELT SALT, HERUNDER ELIGLUSTAT (SOM TARTRAT); REG. NO/DATE: EU/1/14/974 20150119 |
1409467 | 122015000051 | Germany | ⤷ Sign Up | PRODUCT NAME: ELIGLUSTAT; REGISTRATION NO/DATE: EU/1/14/974 20150119 |
1409467 | 92717 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: ELIGLUSTAT, EVENTUELLEMENT SOUS LA FORME D UN SEL PHYSIOLOGIQUEMENT ACCEPTABLE. FIRST REGISTRATION: 20150121 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |