DrugPatentWatch Database Preview
CERDELGA Drug Profile
» See Plans and Pricing
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
Summary for CERDELGA
| International Patents: | 49 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 18 |
| Clinical Trials: | 2 |
| Drug Prices: | Drug price information for CERDELGA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CERDELGA |
| DailyMed Link: | CERDELGA at DailyMed |
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
| 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 | Glucosylceramide Synthase Inhibitors P-Glycoprotein Inhibitors Cytochrome P450 2D6 Inhibitors |
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 | Y | Start Trial | |||
| 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 | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for CERDELGA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 2454453 | Start Trial |
| Japan | 4708073 | Start Trial |
| Japan | 6182254 | Start Trial |
| Spain | 2395463 | Start Trial |
| Japan | 2010095546 | Start Trial |
| Israel | 159905 | Start Trial |
| >Country | >Patent Number | >Estimated 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 | 15C0036 | France | Start Trial | PRODUCT NAME: ELIGLUSTAT,EVENTUELLEMENT SOUS FORME D'UN SEL PHYSIOLOGIQUEMENT ACCEPTABLE; REGISTRATION NO/DATE: EU/1/14/974 20150119 |
| 1409467 | CR 2015 00035 | Denmark | Start Trial | 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 | Start Trial | PRODUCT NAME: ELIGLUSTAT; REGISTRATION NO/DATE: EU/1/14/974 20150119 |
| 1409467 | 587 | Finland | Start Trial | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
