Dapagliflozin; metformin hydrochloride - Generic Drug Details
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What are the generic drug sources for dapagliflozin; metformin hydrochloride and what is the scope of patent protection?
Dapagliflozin; metformin hydrochloride
is the generic ingredient in two branded drugs marketed by Astrazeneca Ab and is included in two NDAs. There are seven 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 thirty-six patent family members in forty-six countries.
Two suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for dapagliflozin; metformin hydrochloride
International Patents: | 236 |
US Patents: | 7 |
Tradenames: | 2 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 2 |
Clinical Trials: | 97 |
DailyMed Link: | dapagliflozin; metformin hydrochloride at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for dapagliflozin; metformin hydrochloride
Generic Entry Date for dapagliflozin; metformin hydrochloride*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, EXTENDED RELEASE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for dapagliflozin; metformin hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Nanjing First Hospital, Nanjing Medical University | Phase 3 |
University of Sydney | Phase 3 |
The University of New South Wales | Phase 3 |
See all dapagliflozin; metformin hydrochloride clinical trials
Generic filers with tentative approvals for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | 2.5MG;1GM | TABLET, EXTENDED RELEASE;ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 10MG;1GM | TABLET, EXTENDED RELEASE;ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 10MG;500MG | TABLET, EXTENDED RELEASE;ORAL |
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 | Biguanide Sodium-Glucose Cotransporter 2 Inhibitor |
Mechanism of Action | Sodium-Glucose Transporter 2 Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for dapagliflozin; metformin hydrochloride
Paragraph IV (Patent) Challenges for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
XIGDUO XR | Extended-release Tablets | dapagliflozin; metformin hydrochloride | 2.5 mg/1000 mg | 205649 | 1 | 2018-10-29 |
XIGDUO XR | Extended-release Tablets | dapagliflozin; metformin hydrochloride | 5 mg/500 mg 5 mg/1000 mg 10 mg/500 mg 10 mg/1000 mg | 205649 | 10 | 2018-01-08 |
US Patents and Regulatory Information for dapagliflozin; metformin hydrochloride
Expired US Patents for dapagliflozin; metformin hydrochloride
International Patents for dapagliflozin; metformin hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Lithuania | C2498758 | ⤷ Try a Trial | |
Japan | 6622862 | ⤷ Try a Trial | |
China | 102639125 | Methods for treating type 2 diabetes in patients resistant to previous treatment with other anti-diabetic drugs employing an SGLT2 inhibitor and compositions thereof | ⤷ Try a Trial |
Singapore | 10201402181S | CRYSTALLINE SOLVATES AND COMPLEXES OF (1S) -1, 5-ANHYDRO-1-C- (3- ( (PHENYL) METHYL) PHENYL) -D-GLUCITOL DERIVATIVES WITH AMINO ACIDS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES | ⤷ Try a Trial |
Canada | 2987757 | FORMULATIONS DE COMPRIME BICOUCHE (BILAYER TABLET FORMULATIONS) | ⤷ Try a Trial |
Mexico | 2012005416 | FORMULACIONES DE TABLETAS BICAPA. (BILAYER TABLET FORMULATIONS.) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for dapagliflozin; metformin hydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1506211 | 122013000033 | Germany | ⤷ Try a Trial | PRODUCT NAME: DAPAGLIFLOZIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112 |
2498758 | CR 2020 00017 | Denmark | ⤷ Try a Trial | PRODUCT NAME: METFORMIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; SAXAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SOLVAT DERAF; REG. NO/DATE: EU/1/19/1401 20191113 |
1506211 | C20130006 00074 | Estonia | ⤷ Try a Trial | PRODUCT NAME: DAPAGLIFLOZIN;REG NO/DATE: K(2012)8378 12.11.2012 |
1506211 | 92496 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: COMBINAISON DE DAPAGLIFLOZINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DE METFORMINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,TELLE QUE PROTEGEE PAR LE BREVET DE BASE EP1506211 B1 |
1506211 | 92182 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES |
1506211 | DO 136; 5005-2013 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: DAPAGLIFOZIN:REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112; FORMER OWNER: BRISTOL |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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