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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 sixty-three patent family members in forty-six countries.
There are twenty-six drug master file entries for dapagliflozin; metformin hydrochloride. One supplier is listed for this compound. There is one tentative approval for this compound.
Recent Clinical Trials for dapagliflozin; metformin hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
|The University of The West Indies||Phase 2/Phase 3|
|Dong-A ST Co., Ltd.||Phase 3|
|Chang Gung Memorial Hospital||Phase 2|
Generic filers with tentative approvals for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
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 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
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Astrazeneca Ab||XIGDUO XR||dapagliflozin; metformin hydrochloride||TABLET, EXTENDED RELEASE;ORAL||205649-002||Oct 29, 2014||RX||Yes||No||Start Trial||Start Trial||Start Trial|
|Astrazeneca Ab||QTERNMET XR||dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride||TABLET, EXTENDED RELEASE;ORAL||210874-003||May 2, 2019||RX||Yes||No||Start Trial||Start Trial||Start Trial|
|Astrazeneca Ab||XIGDUO XR||dapagliflozin; metformin hydrochloride||TABLET, EXTENDED RELEASE;ORAL||205649-002||Oct 29, 2014||RX||Yes||No||Start Trial||Start Trial||Y||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|1506211||18/2013||Austria||Start Trial||PRODUCT NAME: DAPAGLIFLOZIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112|
|1506211||PA2014026||Lithuania||Start Trial||PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116|
|2498758||LUC00152||Luxembourg||Start Trial||PRODUCT NAME: METFORMINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; SAXAGLIPTINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; DAPAGLIFLOZINE OU UN SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1401 20191113|
|>Patent Number||>Supplementary Protection Certificate||>SPC Country||>SPC Expiration||>SPC Description|
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