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CERDELGA Drug 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 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 19th, 2018.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be June 26th, 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. Historic data indicate that 48% of cases that proceed to trial are decided in favor of the generic patent challenger.
Summary for CERDELGA
| International Patents: | 49 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 17 |
| 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 |
|---|---|
| Sanofi | N/A |
| National Taiwan University Hospital | N/A |
| Sanofi | Phase 3 |
Recent Litigation for CERDELGA
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| GENZYME CORP. v. DR. REDDYS LABORATORIES, INC. | 2018-11-21 |
| Genzyme Corp. v. Cipla Limited | 2018-11-20 |
| Genzyme Corp. v. Apotex Corp. | 2018-11-14 |
Pharmacology for CERDELGA
| Drug Class | Glucosylceramide Synthase Inhibitor |
| Mechanism of Action | Glucosylceramide Synthase Inhibitors P-Glycoprotein Inhibitors Cytochrome P450 2D6 Inhibitors |
Synonyms for CERDELGA
| 1000191-50-3 |
| 928659-70-5 |
| 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 |
| DTXSID50239166 |
| Eliglustat (hemitartrate) |
| Eliglustat (Tartrate) |
| eliglustat hemitartrate |
| Eliglustat hemitartrate(Genz-99067) |
| eliglustat L-tartrate |
| Eliglustat tartrate |
| Eliglustat tartrate (JAN/USAN) |
| Eliglustat tartrate [USAN] |
| Genz 112638 |
| 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) |
| SB16832 |
| UNII-N0493335P3 |
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 | |||
| >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 |
|---|---|---|
| Austria | 555102 | Start Trial |
| World Intellectual Property Organization (WIPO) | 03008399 | Start Trial |
| Brazil | 122015016313 | Start Trial |
| Denmark | 2067775 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for CERDELGA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1409467 | 587 | Finland | Start Trial | |
| 1409467 | 244 4-2015 | Slovakia | Start Trial | PRODUCT NAME: ELIGLUSTAT (VO FORME TARTRATU); REGISTRATION NO/DATE: EU/1/14/974 20150121 |
| 1409467 | C300738 | Netherlands | Start Trial | PRODUCT NAME: ELIGLUSTAT, OF FYSIOLOGISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/14/974 20150119 |
| 1409467 | 122015000051 | Germany | Start Trial | PRODUCT NAME: ELIGLUSTAT; REGISTRATION NO/DATE: EU/1/14/974 20150119 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
