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
*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 |
| The Fifth Affiliated Hospital of Zunyi Medical College | Phase 4 |
| First People's Hospital, Shunde China | Phase 4 |
See all DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE clinical trials
Anatomical Therapeutic Chemical (ATC) Classes for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
US Patents and Regulatory Information for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN 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 | QTERNMET XR | dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210874-001 | May 2, 2019 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Astrazeneca Ab | QTERNMET XR | dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210874-002 | May 2, 2019 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Astrazeneca Ab | QTERNMET XR | dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210874-003 | May 2, 2019 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Astrazeneca Ab | QTERNMET XR | dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210874-002 | May 2, 2019 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astrazeneca Ab | QTERNMET XR | dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210874-003 | May 2, 2019 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca Ab | QTERNMET XR | dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210874-003 | May 2, 2019 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca Ab | QTERNMET XR | dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210874-001 | May 2, 2019 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca Ab | QTERNMET XR | dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210874-003 | May 2, 2019 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Russian Federation | 2262507 | С-АРИЛГЛЮКОЗИДНЫЕ ИНГИБИТОРЫ SGLT2 (C-ARYLGLUCOSIDE INHIBITORS OF SGLT-2) | ⤷ Sign Up |
| Hong Kong | 1068214 | C-aryl glucoside sglt2 inhibitors and method | ⤷ Sign Up |
| South Korea | 20070027560 | COATED TABLET FORMULATION AND METHOD | ⤷ Sign Up |
| Peru | 20090185 | FORMULACIONES FARMACEUTICAS QUE CONTIENEN UN INHIBIDOR SGLT2 | ⤷ Sign Up |
| >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 |
|---|---|---|---|---|
| 2498758 | PA2020003,C2498758 | Lithuania | ⤷ Sign Up | PRODUCT NAME: METFORMINO HIDROCHLORIDAS; SAKSAGLIPTINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; DAPAGLIFLOZINAS ARBA FARMACINIU POZIURIU PRIIMTINAS JO SOLVATAS; REGISTRATION NO/DATE: EU/1/19/1401 20191111 |
| 1506211 | PA2013008 | Lithuania | ⤷ Sign Up | PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112 |
| 1506211 | 588 | Finland | ⤷ Sign Up | |
| 1506211 | C 2014 029 | Romania | ⤷ Sign Up | 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 |
