Eliglustat tartrate - Generic Drug Details
✉ Email this page to a colleague
What are the generic 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 |
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
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 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Genzyme Corp | CERDELGA | eliglustat tartrate | CAPSULE;ORAL | 205494-001 | Aug 19, 2014 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Genzyme Corp | CERDELGA | eliglustat tartrate | CAPSULE;ORAL | 205494-001 | Aug 19, 2014 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Teva Pharms Usa Inc | ELIGLUSTAT TARTRATE | eliglustat tartrate | CAPSULE;ORAL | 212474-001 | Dec 27, 2021 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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 |
---|---|---|---|
Peru | 20171255 | FORMA CRISTALINA Y AMORFA DE HEMITARTRATO DE GENZ 112638 COMO INHIBIDOR DE GLUCOSILCERAMIDA SINTASA | ⤷ Try a Trial |
South Korea | 20200100697 | 고쉐병의 치료 방법 | ⤷ Try a Trial |
Singapore | 10201800136Q | AN AMORPHOUS AND A CRYSTALLINE FORM OF GENZ 112638 HEMITARTRATE AS INHIBITOR OF GLUCOSYLCERAMIDE SYNTHASE | ⤷ Try a Trial |
Eurasian Patent Organization | 201592195 | ИНГИБИТОРЫ ГЛЮКОЗИЛЦЕРАМИДСИНТАЗЫ | ⤷ 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 | 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 | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.