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 |
---|---|
Genzyme, a Sanofi Company | Phase 1 |
Sanofi | 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 |
---|---|---|---|
Hong Kong | 1153733 | ⤷ Try a Trial | |
Brazil | 122015016314 | método para preparar um composto acíclico, método para preparar um composto amina, método de preparar um composto como esfingosina e método para preparar um composto como ceramida | ⤷ Try a Trial |
Hong Kong | 1203485 | 在組合療法中治療戈謝病或法布里病的 (GENZ 112638 FOR TREATING GAUCHER OR FABRY DISEASE IN COMBINATION THERAPY GENZ112638) | ⤷ Try a Trial |
San Marino | T201600273 | GENZ 112638 PER TRATTARE LA MALATTIA DI GAUCHER O FABRY IN TERAPIA DI COMBINAZIONE | ⤷ Try a Trial |
Slovenia | 2504332 | ⤷ Try a Trial | |
Japan | 2017075151 | UDP−グルコース:N−アシルスフィンゴシングルコシルトランスフェラーゼインヒビターの合成 (SYNTHESIS OF UDP-GLUCOSE:N-ACYLSPHINGOSINE GLUCOSYL TRANSFERASE INHIBITORS) | ⤷ 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 | 37/2015 | Austria | ⤷ Try a Trial | PRODUCT NAME: ELIGLUSTAT, OPTIONAL IN DER FORM EINES PHYSIOLOGISCH AKZEPTABLEN SALZES; REGISTRATION NO/DATE: EU/1/14/974 20150119 |
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 | C300738 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ELIGLUSTAT, OF FYSIOLOGISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/14/974 20150119 |
1409467 | 2015/027 | Ireland | ⤷ Try a Trial | PRODUCT NAME: ELIGLUSTAT, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/14/974 20150119 |
1409467 | 92717 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: ELIGLUSTAT, EVENTUELLEMENT SOUS LA FORME D UN SEL PHYSIOLOGIQUEMENT ACCEPTABLE. FIRST REGISTRATION: 20150121 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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