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Dapagliflozin; metformin hydrochlorideis the generic ingredient in two branded drugs marketed by Astrazeneca Ab and is included in two NDAs. There are eleven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.
Dapagliflozin; metformin hydrochloride has two hundred and fifty-one patent family members in forty-five countries.
There are twenty-six drug master file entries for dapagliflozin; metformin hydrochloride. One supplier is listed for this compound.
Recent Clinical Trials for dapagliflozin; metformin hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
|Swedish Healthcare Regions||Phase 4|
|Uppsala University Hospital||Phase 4|
|Swedish National Board of Health and Welfare||Phase 4|
Pharmacology for dapagliflozin; metformin hydrochloride
|Drug Class||Sodium-Glucose Cotransporter 2 Inhibitor |
|Mechanism of Action||Sodium-Glucose Transporter 2 Inhibitors |
Paragraph IV (Patent) Challenges for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
|Country||Patent Number||Estimated Expiration|
|>Country||>Patent Number||>Estimated Expiration|
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|1506211||2013/013||Ireland||Start Trial||PRODUCT NAME: DAPAGLIFLOZIN AND PHARACEUTICALLY ACCEPTABLE SALTS THREOF; REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112|
|1506211||PA2014026,C1506211||Lithuania||Start Trial||PRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116|
|1506211||PA2013008||Lithuania||Start Trial||PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112|
|1506211||2014C/041||Belgium||Start Trial||PRODUCT NAME: LA COMBINAISON DE DAPAGLIFLOZINE (OU SON SEL PHARMACEUTIQUEMENT ACCEPTABLE); AUTHORISATION NUMBER AND DATE: EU/1/13/900 20140121|
|1506211||136 5005-2013||Slovakia||Start Trial||PRODUCT NAME: DAPAGLIFLOZIN; FIRST REGISTRATION NO/DATE: EU/1/12/795/001, EU/1/12/795/002, EU/1/12/795/003, EU/1/12/795/004, EU/1/12/795/005, EU/1/12/795/006, EU/1/12/795/007, EU/1/12/795/007, EU/1/12/795/008, EU/1/12/795/009, EU/1/12/795/010 20121112|
|1506211||C01506211/02||Switzerland||Start Trial||PRODUCT NAME: DAPAGLIFLOZIN + METFORMIN; REGISTRATION NO/DATE: SWISSMEDIC 65377 16.07.2015|
|>Patent Number||>Supplementary Protection Certificate||>SPC Country||>SPC Expiration||>SPC Description|
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