Dapagliflozin; saxagliptin hydrochloride - Generic Drug Details
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What are the generic sources for dapagliflozin; saxagliptin hydrochloride and what is the scope of patent protection?
Dapagliflozin; saxagliptin hydrochloride
is the generic ingredient in one branded drug marketed by Astrazeneca Ab and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Dapagliflozin; saxagliptin hydrochloride has three hundred and ten patent family members in forty-eight countries.
One supplier is listed for this compound.
Summary for dapagliflozin; saxagliptin hydrochloride
International Patents: | 310 |
US Patents: | 7 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 26 |
DailyMed Link: | dapagliflozin; saxagliptin hydrochloride at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for dapagliflozin; saxagliptin hydrochloride
Generic Entry Date for dapagliflozin; saxagliptin hydrochloride*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;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; saxagliptin hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Erlangen-Nürnberg Medical School | Phase 4 |
Sabyasachi Sen | Phase 4 |
First People's Hospital, Shunde China | Phase 4 |
See all dapagliflozin; saxagliptin hydrochloride clinical trials
Pharmacology for dapagliflozin; saxagliptin hydrochloride
Drug Class | Dipeptidyl Peptidase 4 Inhibitor Sodium-Glucose Cotransporter 2 Inhibitor |
Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors Sodium-Glucose Transporter 2 Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for dapagliflozin; saxagliptin hydrochloride
Paragraph IV (Patent) Challenges for DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
QTERN | Tablets | dapagliflozin; saxagliptin hydrochloride | 5 mg/5 mg | 209091 | 1 | 2020-07-29 |
QTERN | Tablets | dapagliflozin; saxagliptin hydrochloride | 10 mg/5 mg | 209091 | 5 | 2018-01-08 |
US Patents and Regulatory Information for dapagliflozin; 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 | QTERN | dapagliflozin; saxagliptin hydrochloride | TABLET;ORAL | 209091-001 | Feb 27, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Astrazeneca Ab | QTERN | dapagliflozin; saxagliptin hydrochloride | TABLET;ORAL | 209091-001 | Feb 27, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Astrazeneca Ab | QTERN | dapagliflozin; saxagliptin hydrochloride | TABLET;ORAL | 209091-001 | Feb 27, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Astrazeneca Ab | QTERN | dapagliflozin; saxagliptin hydrochloride | TABLET;ORAL | 209091-002 | May 2, 2019 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | 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; saxagliptin hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Astrazeneca Ab | QTERN | dapagliflozin; saxagliptin hydrochloride | TABLET;ORAL | 209091-002 | May 2, 2019 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca Ab | QTERN | dapagliflozin; saxagliptin hydrochloride | TABLET;ORAL | 209091-001 | Feb 27, 2017 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca Ab | QTERN | dapagliflozin; saxagliptin hydrochloride | TABLET;ORAL | 209091-002 | May 2, 2019 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca Ab | QTERN | dapagliflozin; saxagliptin hydrochloride | TABLET;ORAL | 209091-001 | Feb 27, 2017 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for dapagliflozin; saxagliptin hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 20160013276 | 다파글리플로진 프로필렌 글리콜 수화물을 함유하는 제약 제형 (PHARMACEUTICAL FORMULATIONS CONTAINING DAPAGLIFLOZIN PROPYLENE GLYCOL HYDRATE) | ⤷ Sign Up |
Montenegro | P13008 | C-ARIL GLUKOZID SGLT2 INHIBITORI i POSTUPAK ZA NJIHOVU UPOTREBU (C-ARYL GLUCOSIDE SGLT2 INHIBITORS AND METHOD) | ⤷ Sign Up |
Portugal | 2139494 | ⤷ Sign Up | |
Argentina | 065809 | FORMULACIONES FARMACEUTICAS QUE CONTIENEN UN INHIBIDOR SGLT2 | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for dapagliflozin; saxagliptin hydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1506211 | 1390017-0 | Sweden | ⤷ Sign Up | PRODUCT NAME: DAPAGLIFLOZIN OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/12/795/001 20121112 |
2139494 | SPC/GB20/028 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: SAXAGLIPTIN AND DAPAGLIFLOZIN; REGISTERED: UK EU/1/16/1108 (NI) 20160719; UK PLGB 17901/0339 20160719 |
2139494 | 301054 | Netherlands | ⤷ Sign Up | PRODUCT NAME: SAXAGLIPTIN AND DAPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/16/1108 20160719 |
2139494 | 34/2020 | Austria | ⤷ Sign Up | PRODUCT NAME: DAPAGLIFLOZIN PROPYLENGYLKOL HYDRAT/SAXAGLIPTIN; REGISTRATION NO/DATE: EU/1/16/1108 (MITTEILUNG) 20160715 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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