Dapagliflozin; metformin hydrochloride - Generic Drug Details
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What are the generic sources for dapagliflozin; metformin hydrochloride and what is the scope of freedom to operate?
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 |
Monash University | Phase 3 |
University of Sydney | 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 | 5MG;500MG | TABLET, EXTENDED RELEASE;ORAL |
⤷ 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 |
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 |
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Astrazeneca Ab | XIGDUO XR | dapagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205649-004 | Oct 29, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Ab | XIGDUO XR | dapagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205649-003 | Oct 29, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Ab | XIGDUO XR | dapagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205649-001 | Oct 29, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Ab | XIGDUO XR | dapagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205649-005 | Jul 28, 2017 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Ab | XIGDUO XR | dapagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205649-005 | Jul 28, 2017 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for dapagliflozin; metformin hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Portugal | 1506211 | ⤷ Try a Trial | |
Eurasian Patent Organization | 200900066 | КРИСТАЛЛИЧЕСКИЕ СОЛЬВАТЫ И КОМПЛЕКСЫ ПРОИЗВОДНЫХ (1S)-1,5-АНГИДРО-1-C-(3-((ФЕНИЛ)МЕТИЛ)ФЕНИЛ) -D-ГЛЮЦИТОЛА С АМИНОКИСЛОТАМИ В КАЧЕСТВЕ ИНГИБИТОРОВ SGLT2 ДЛЯ ЛЕЧЕНИЯ ДИАБЕТА | ⤷ Try a Trial |
Canada | 2987757 | FORMULATIONS DE COMPRIME BICOUCHE (BILAYER TABLET FORMULATIONS) | ⤷ Try a Trial |
China | 1896088 | C-aryl glucoside sglt2 inhibitors | ⤷ Try a Trial |
Russian Federation | 2004137489 | C-АРИЛ ГЛЮКОЗИДНЫЕ SGLT2 ИНГИБИТОРЫ И СПОСОБ ИХ ПРИМЕНЕНИЯ | ⤷ 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 |
---|---|---|---|---|
2498758 | 2090013-0 | Sweden | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION OF METFORMIN HYDROCHLORIDE, SAXAGLIPTIN OR A PHARMACEUTICALLY ACCEPABLE SALT THEREOF, AND DAPAGLIFLOZIN OR PH ARMACEUTICALLY ACCEPTABLE SOLVATE THEREOF; REG. NO/DATE: EU/1/19/1401 20191113 |
1506211 | C 2013 012 | Romania | ⤷ Try a Trial | PRODUCT NAME: DAPAGLIFLOZIN SI SARURILE ACCEPTABILE FARMACEUTIC ALEACESTUIA (2S, 3R, 4R, 5S, 6R)-2-[4-CLOR-3-(4-ETOXIBENZIL)FENIL]-6-(HIDROXIMETIL)TETRAHIDRO-2H-PIRAN-3,4,5-TRIOL; NATIONAL AUTHORISATION NUMBER: RO EU/1/12/795/001, RO EU/1/12/795/002, RO EU/1/12/795/003, RO EU/1/12/795/004, RO EU/1/12/795/005, RO EU/1/12/795/006, RO EU/1/12/795/007, RO EU/1/12/795/008, RO EU/1/12/795/009, RO EU/1/12/795/001/010; DATE OF NATIONAL AUTHORISATION: 20121112; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/12/795/001, EMEA EU/1/12/795/002, EMEA EU/1/12/795/003, EMEA EU/1/12/795/004, EMEA EU/1/12/795/005, EMEA EU/1/12/795/006, EMEA EU/1/12/795/007, EMEA EU/1/12/795/008 [...] |
2139494 | 122020000043 | Germany | ⤷ Try a Trial | PRODUCT NAME: SAXAGLIPTIN UND DAPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/16/1108 20160715 |
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 | LUC00152 | Luxembourg | ⤷ Try a 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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