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Empagliflozinis the generic ingredient in five branded drugs marketed by Boehringer Ingelheim and is included in five NDAs. There are eighteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.
Empagliflozin has two hundred and twenty-three patent family members in forty-four countries.
There are twenty-two drug master file entries for empagliflozin. Four suppliers are listed for this compound. There are six tentative approvals for this compound.
Summary for empagliflozin
|Drug Master File Entries:||22|
|Finished Product Suppliers / Packagers:||4|
|Raw Ingredient (Bulk) Api Vendors:||75|
|Formulation / Manufacturing:||see details|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for empagliflozin|
|What excipients (inactive ingredients) are in empagliflozin?||empagliflozin excipients list|
|DailyMed Link:||empagliflozin at DailyMed|
Recent Clinical Trials for empagliflozin
Identify potential brand extensions & 505(b)(2) entrants
|Shahid Beheshti University of Medical Sciences||N/A|
Generic filers with tentative approvals for EMPAGLIFLOZIN
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for empagliflozin
|Drug Class||Sodium-Glucose Cotransporter 2 Inhibitor |
|Mechanism of Action||Sodium-Glucose Transporter 2 Inhibitors |
ATC Classes for empagliflozin
|Country||Patent Number||Estimated Expiration|
|European Patent Office||1888552||⤷ Free Forever Trial|
|China||103467423||⤷ Free Forever Trial|
|Taiwan||I472325||⤷ Free Forever Trial|
|Hong Kong||1188776||⤷ Free Forever Trial|
|South Korea||20100049595||⤷ Free Forever Trial|
|Israel||241101||⤷ Free Forever Trial|
|>Country||>Patent Number||>Estimated Expiration|
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|1730131||C300696||Netherlands||⤷ Free Forever Trial||PRODUCT NAME: EMPAGLIFLOZINE EN ZOUTEN DAARVAN, IN HET BIJZONDER EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930/001-009 20140522|
|2187879||300872||Netherlands||⤷ Free Forever Trial||PRODUCT NAME: COMBINATIE VAN EMPAGLIFLOZINE EN LINAGLIPTINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/16/1146 20161115|
|2187879||CA 2017 00019||Denmark||⤷ Free Forever Trial||PRODUCT NAME: KOMBINATION AF EMPAGLIFLOZIN OG LINAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/16/1146/001-018 20161115|
|1730131||C20140033 00134||Estonia||⤷ Free Forever Trial||PRODUCT NAME: EMPAGLIFLOSIIN;REG NO/DATE: EU/1/14/930 27.05.2014|
|2187879||LUC00017||Luxembourg||⤷ Free Forever Trial||PRODUCT NAME: GLYXAMBI- EMPAGLIFLOZINE/LINAGLIPTINE; AUTHORISATION NUMBER AND DATE: EU/1/16/1146 20161115|
|1730131||122014000099||Germany||⤷ Free Forever Trial||PRODUCT NAME: EMPAGLIFLOZIN UND DESSEN SALZE, INSBESONDERE EMPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/14/930 20140522|
|>Patent Number||>Supplementary Protection Certificate||>SPC Country||>SPC Expiration||>SPC Description|
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