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 |
the Fifth Affiliated Hospital of Zunyi Medical University | Phase 4 |
Peking University Shenzhen Hospital | Phase 4 |
See all DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE clinical trials
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 | 210874-002 | May 2, 2019 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Astrazeneca Ab | QTERNMET XR | dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210874-001 | May 2, 2019 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Astrazeneca Ab | QTERNMET XR | dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210874-002 | May 2, 2019 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>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 | 210874-002 | May 2, 2019 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Ab | QTERNMET XR | dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210874-004 | May 2, 2019 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Ab | QTERNMET XR | dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210874-001 | May 2, 2019 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
Philippines | 12012500168 | CRYSTALLINE SOLVATES AND COMPLEXES OF (IS)-1,5-ANHYDRO-L-C-(3-((PHENYL)METHYL)PHENYL)-D-GLUCITOL DERIVATIVES WITH AMINO ACIDS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES | ⤷ Try a Trial |
South Korea | 20020063876 | C-아릴 글루코시드 SGLT2 억제제 (- 2 C-Aryl Glucoside SGLT2 Inhibitors) | ⤷ Try a Trial |
South Korea | 101502292 | ⤷ 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 |
---|---|---|---|---|
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 | 136 5005-2013 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: DAPAGLIFLOZIN; FIRST REGISTRATION NO/DATE: EU/1/12/795/001, EU/1/12/795/002, EU/1/12/795/003, EU/1/12/795/004, EU/1/12/795/005, EU/1/12/795/006, EU/1/12/795/007, EU/1/12/795/007, EU/1/12/795/008, EU/1/12/795/009, EU/1/12/795/010 20121112 |
1506211 | 92182 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |