DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE - Generic Drug Details
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What are the generic drug sources for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride and what is the scope of freedom to operate?
Dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride
is the generic ingredient in one branded drug marketed by Astrazeneca Ab and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.Dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride has three hundred and forty-six patent family members in forty-eight countries.
Summary for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
International Patents: | 346 |
US Patents: | 6 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Clinical Trials: | 19 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE |
DailyMed Link: | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
Generic Entry Date for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN 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; SAXAGLIPTIN HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Sabyasachi Sen | Phase 4 |
First People's Hospital, Shunde China | Phase 4 |
Zhujiang Hospital | Phase 4 |
See all DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE clinical trials
US Patents and Regulatory Information for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
Expired US Patents for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
International Patents for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 3078369 | FORMULATION DE COMPRIMÉ REVÊTU ET PROCÉDÉ CORRESPONDANT (COATED TABLET FORMULATION AND METHOD) | ⤷ Try a Trial |
Spain | 2791682 | ⤷ Try a Trial | |
European Patent Office | 1506211 | C-ARYL GLUCOSIDES EN TANT QU'INHIBITEURS DE SGLT-2 ET METHODE CORRESPONDANTE (C-ARYL GLUCOSIDE SGLT2 INHIBITORS AND METHOD) | ⤷ Try a Trial |
New Zealand | 551591 | Coated tablet formulation and method | ⤷ Try a Trial |
Hungary | E029039 | ⤷ Try a Trial | |
Norway | 346828 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2139494 | 122020000043 | Germany | ⤷ Try a Trial | PRODUCT NAME: SAXAGLIPTIN UND DAPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/16/1108 20160715 |
1506211 | 18/2013 | Austria | ⤷ Try a Trial | PRODUCT NAME: DAPAGLIFLOZIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112 |
1506211 | C20140021 00131 | Estonia | ⤷ Try a Trial | PRODUCT NAME: DAPAGLIFLOSIIN/METFORMIIN;REG NO/DATE: K(2014)308 (LOPLIK) 21.01.2014 |
1506211 | PA2014026,C1506211 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116 |
2139494 | CA 2020 00035 | Denmark | ⤷ Try a Trial | PRODUCT NAME: SAXAGLIPTIN OG DAPAGLIFLOZIN; REG. NO/DATE: EU/1/16/1108 20160719 |
2139494 | 132020000000115 | Italy | ⤷ Try a Trial | PRODUCT NAME: SAXAGLIPTIN E DAPAGLIFLOZIN(QTERN); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1108, 20160719 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |