Eliglustat tartrate - Generic Drug Details
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What are the generic drug sources for eliglustat tartrate and what is the scope of freedom to operate?
Eliglustat tartrate
is the generic ingredient in two branded drugs marketed by Genzyme Corp, Aizant, Dr Reddys, Teva Pharms Usa Inc, and Upsher Smith Labs, and is included in five NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Eliglustat tartrate has one hundred and sixty-one patent family members in forty-four countries.
There are six drug master file entries for eliglustat tartrate. One supplier is listed for this compound.
Summary for eliglustat tartrate
International Patents: | 161 |
US Patents: | 4 |
Tradenames: | 2 |
Applicants: | 5 |
NDAs: | 5 |
Drug Master File Entries: | 6 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 44 |
Clinical Trials: | 6 |
Patent Applications: | 176 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for eliglustat tartrate |
DailyMed Link: | eliglustat tartrate at DailyMed |
Recent Clinical Trials for eliglustat tartrate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Sanofi | Phase 1 |
Genzyme, a Sanofi Company | Phase 1 |
Genzyme, a Sanofi Company | Phase 3 |
Pharmacology for eliglustat tartrate
Drug Class | Glucosylceramide Synthase Inhibitor |
Mechanism of Action | Cytochrome P450 2D6 Inhibitors Glucosylceramide Synthase Inhibitors P-Glycoprotein Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for eliglustat tartrate
Paragraph IV (Patent) Challenges for ELIGLUSTAT TARTRATE
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 eliglustat tartrate
Expired US Patents for eliglustat tartrate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Genzyme Corp | CERDELGA | eliglustat tartrate | CAPSULE;ORAL | 205494-001 | Aug 19, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Genzyme Corp | CERDELGA | eliglustat tartrate | CAPSULE;ORAL | 205494-001 | Aug 19, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Genzyme Corp | CERDELGA | eliglustat tartrate | CAPSULE;ORAL | 205494-001 | Aug 19, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for eliglustat tartrate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Denmark | 2266968 | ⤷ Try a Trial | |
Japan | 2013136618 | SYNTHESIS OF UDP-GLUCOSE: N-ACYLSPHINGOSINE GLUCOSYL TRANSFERASE INHIBITORS | ⤷ Try a Trial |
Canada | 3140959 | FORME AMORPHE ET CRISTALLINE DE GENZ 112638 HEMITARTRATE COMME INHIBITEUR DE SYNTHASE DE GLUCOSYLCERAMIDE (AN AMORPHOUS AND A CRYSTALLINE FORM OF GENZ 112638 HEMITARTRATE AS INHIBITOR OF GLUCOSYLCERAMIDE SYNTHASE) | ⤷ Try a Trial |
South Korea | 20180049255 | 글루코실세라마이드 신타아제의 억제제로서 GENZ 112638 헤미타르타르산염의 무정형 및 결정질 형태 (112638 AN AMORPHOUS AND A CRYSTALLINE FORM OF GENZ 112638 HEMITARTRATE AS INHIBITOR OF GLUCOSYLCERAMIDE SYNTHASE) | ⤷ Try a Trial |
Spain | 2875382 | ⤷ Try a Trial | |
Philippines | 12015502514 | AN AMORPHOUS AND CRYSTALLINE FORM OF GENZ 112638 HEMITARTRAT AS INHIBITOR OF GLUCOSYLCERAMIDE SYNTHASE | ⤷ Try a Trial |
Poland | 3133070 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for eliglustat tartrate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1409467 | 587 | Finland | ⤷ Try a Trial | |
1409467 | 132016000023075 | Italy | ⤷ Try a Trial | PRODUCT NAME: ELIGLUSTAT, OPZIONALMENTE NELLA FORMA DI UN SALE FARMACOLOGICAMENTE ACCETTABILE(CERDELGA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/974, 20150119 |
1409467 | CR 2015 00035 | Denmark | ⤷ Try a 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 | C20150027 00161 | Estonia | ⤷ Try a Trial | PRODUCT NAME: ELIGLUSTAAT;REG NO/DATE: EU/1/14/974 21.01.2015 |
1409467 | 122015000051 | Germany | ⤷ Try a Trial | PRODUCT NAME: ELIGLUSTAT; REGISTRATION NO/DATE: EU/1/14/974 20150119 |
1409467 | 1590029-3 | Sweden | ⤷ Try a Trial | PRODUCT NAME: ELIGLUSTAT, VALFRITT I FORM AV ETT FYSIOLOGISKT GODTAGBART SALT; REG. NO/DATE: EU/1/14/974 20150121 |
1409467 | 244 4-2015 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: ELIGLUSTAT (VO FORME TARTRATU); REGISTRATION NO/DATE: EU/1/14/974 20150121 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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