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.
DrugPatentWatch® Litigation and Generic Entry Outlook for Cerdelga
A generic version of CERDELGA was approved as eliglustat tartrate by AIZANT on September 8th, 2021.
Summary for CERDELGA
| International Patents: | 163 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 29 |
| Clinical Trials: | 3 |
| Patent Applications: | 113 |
| 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 |
Recent Clinical Trials for CERDELGA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Taiwan University Hospital | N/A |
| Sanofi | 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 |
Anatomical Therapeutic Chemical (ATC) Classes for CERDELGA
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 |
International Patents for CERDELGA
See the table below for patents covering CERDELGA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Israel | 275091 | See Plans and Pricing | |
| Japan | 5227348 | See Plans and Pricing | |
| Peru | 20121337 | FORMA CRISTALINA Y AMORFA DE HEMITARTRATO DE GENZ 112638 COMO INHIBIDOR DE GLUCOSILCERAMIDA SINTASA | See Plans and Pricing |
| >Country | >Patent Number | >Title | >Estimated 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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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.
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