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 freedom to operate?
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 |
Peking University Shenzhen Hospital | 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 |
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Astrazeneca Ab | QTERN | dapagliflozin; saxagliptin hydrochloride | TABLET;ORAL | 209091-002 | May 2, 2019 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Astrazeneca Ab | QTERN | dapagliflozin; saxagliptin hydrochloride | TABLET;ORAL | 209091-002 | May 2, 2019 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Astrazeneca Ab | QTERN | dapagliflozin; saxagliptin hydrochloride | TABLET;ORAL | 209091-001 | Feb 27, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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; 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 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Ab | QTERN | dapagliflozin; saxagliptin hydrochloride | TABLET;ORAL | 209091-002 | May 2, 2019 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Ab | QTERN | dapagliflozin; saxagliptin hydrochloride | TABLET;ORAL | 209091-002 | May 2, 2019 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Ab | QTERN | dapagliflozin; saxagliptin hydrochloride | TABLET;ORAL | 209091-001 | Feb 27, 2017 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for dapagliflozin; saxagliptin hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Brazil | PI0809233 | FORMULAÇÕES FARMACÊUTICAS QUE CONTÊM HIDRATO DE PROPILENO GLICOL DE DAPAGLIFLOZINA | ⤷ Try a Trial |
France | 20C1042 | ⤷ Try a Trial | |
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 | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for dapagliflozin; saxagliptin hydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2139494 | C20200028 00358 | Estonia | ⤷ Try a Trial | PRODUCT NAME: SAKSAGLIPTIIN JA DAPAGLIFLOSIIN;REG NO/DATE: EU/1/16/1108; 19.07.2016 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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