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CERDELGA Drug Profile
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-six 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.
Summary for CERDELGA
| International Patents: | 46 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 16 |
| 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
*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.
Pharmacology for CERDELGA
| Drug Class | Glucosylceramide Synthase Inhibitor |
| Mechanism of Action | Glucosylceramide Synthase Inhibitors P-Glycoprotein Inhibitors Cytochrome P450 2D6 Inhibitors |
Synonyms for CERDELGA
| 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 |
| 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 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 | ➤ 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 | Y | ➤ Sign Up | |||
| 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 | ||||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
Paragraph IV (Patent) Challenges for CERDELGA
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Tartrate Capsules | 84mg | ➤ Subscribe | ➤ Sign Up |
International Patents for CERDELGA
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Hong Kong | 1132267 | ➤ Sign Up |
| European Patent Office | 1384719 | ➤ Sign Up |
| Japan | 2013136618 | ➤ Sign Up |
| World Intellectual Property Organization (WIPO) | 03008399 | ➤ Sign Up |
| Japan | 6182254 | ➤ Sign Up |
| Canada | 2454453 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for CERDELGA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| /2015 | Austria | ➤ Sign Up | PRODUCT NAME: ELIGLUSTAT, OPTIONAL IN DER FORM EINES PHYSIOLOGISCH AKZEPTABLEN SALZES; REGISTRATION NO/DATE: EU/1/14/974 20150119 |
| 90029-3 | Sweden | ➤ Sign Up | PRODUCT NAME: ELIGLUSTAT, VALFRITT I FORM AV ETT FYSIOLOGISKT GODTAGBART SALT; REG. NO/DATE: EU/1/14/974 20150121 |
| 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 |
| 717 | Luxembourg | ➤ Sign Up | PRODUCT NAME: ELIGLUSTAT, EVENTUELLEMENT SOUS LA FORME D UN SEL PHYSIOLOGIQUEMENT ACCEPTABLE. FIRST REGISTRATION: 20150121 |
| C0036 | France | ➤ Sign Up | PRODUCT NAME: ELIGLUSTAT,EVENTUELLEMENT SOUS FORME D'UN SEL PHYSIOLOGIQUEMENT ACCEPTABLE; REGISTRATION NO/DATE: EU/1/14/974 20150119 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
