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 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 |
The George Institute | Phase 3 |
Monash University | 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 | 10MG;500MG | TABLET, EXTENDED RELEASE;ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 5MG;1GM | TABLET, EXTENDED RELEASE;ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 5MG;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 |
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 |
---|---|---|---|
Israel | 214181 | סולבטים גבישיים וקומפלקסים של נגזרות -1,51)(s-אנהידרו(3--1-c-((פניל)מתיל)פניל)-d-גלוציטול עם חומצות אמינו המשמשים כמעכבי 2sglt עבור הטיפול בסוכרת (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 |
Taiwan | I519528 | ⤷ Try a Trial | |
Japan | 5937187 | ⤷ Try a Trial | |
China | 101092409 | C-aryl glucoside sglt2 inhibitors and method | ⤷ Try a Trial |
Japan | 2017222681 | 糖尿病の治療用SGLT2阻害剤としてのアミノ酸を有する(1S)−1,5−アンヒドロ−1−C−(3−((フェニル)メチル)フェニル)−D−グルシトール誘導体の結晶性溶媒和物および複合体 (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 TREATMENT OF DIABETES) | ⤷ Try a Trial |
Eurasian Patent Organization | 202091391 | 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 |
Mexico | PA04011371 | C-ARIL-GLUCOSIDOS COMO INHIBIDORES DE SGLT2 Y METODO. (C-ARYL GLUCOSIDE SGLT2 INHIBITORS AND METHOD.) | ⤷ 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 | 122020000018 | Germany | ⤷ Try a Trial | PRODUCT NAME: METFORMIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; SAXAGLIPTIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; DAPAGLIFLOZIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/19/1401 20191111 |
1506211 | C20140021 00131 | Estonia | ⤷ Try a Trial | PRODUCT NAME: DAPAGLIFLOSIIN/METFORMIIN;REG NO/DATE: K(2014)308 (LOPLIK) 21.01.2014 |
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 | C300677 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121 |
2498758 | CA 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 | 92182 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES |
1506211 | C 2014 029 | Romania | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE DE DAPAGLIFLOZIN SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTUIA SI METFORMINA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/900; DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/900; DATE OF FIRST AUTHORISATION IN EEA: 20140116 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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