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 |
The Sixth Affiliated Hospital of Guangzhou Medical University | 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 | 209091-002 | 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 | 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 | ||||
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 | 209091-001 | Feb 27, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Astrazeneca Ab | QTERN | dapagliflozin; saxagliptin hydrochloride | TABLET;ORAL | 209091-001 | Feb 27, 2017 | RX | Yes | Yes | ⤷ 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; 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 |
Astrazeneca Ab | QTERN | dapagliflozin; saxagliptin hydrochloride | TABLET;ORAL | 209091-001 | Feb 27, 2017 | ⤷ 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 |
---|---|---|---|
Taiwan | 200609002 | Coated tablet formulation and method | ⤷ Try a Trial |
Lithuania | 2508188 | ⤷ Try a Trial | |
New Zealand | 589202 | 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 |
European Patent Office | 2139494 | PRÉPARATIONS PHARMACEUTIQUES CONTENANT DE L'HYDRATE DE PROPYLÈNEGLYCOL DE DAPAGLIFLOZINE (PHARMACEUTICAL FORMULATIONS CONTAINING DAPAGLIFLOZIN PROPYLENE GLYCOL HYDRATE) | ⤷ Try a Trial |
Denmark | 2508188 | ⤷ Try a Trial | |
Ukraine | 96765 | КРИСТАЛЛИЧЕСКИЕ СОЛЬВАТЫ И КОМПЛЕКСЫ ПРОИЗВОДНЫХ (IS)-1,5-АНГИДРО-L-C-(3-((ФЕНИЛ)МЕТИЛ)ФЕНИЛ)-D-ГЛЮЦИТОЛА С АМИНОКИСЛОТАМИ КАК ИНГИБИТОРЫ БЕЛКА SGLT2, ПРИГОДНЫЕ В ЛЕЧЕНИИ ДИАБЕТА;КРИСТАЛІЧНІ СОЛЬВАТИ І КОМПЛЕКСИ ПОХІДНИХ (IS)-1,5-АНГІДРО-L-C-(3-((ФЕНІЛ)МЕТИЛ)ФЕНІЛ)-D-ГЛЮЦИТОЛУ З АМІНОКИСЛОТАМИ ЯК ІНГІБІТОРИ БІЛКА SGLT2, ПРИДАТНІ У ЛІКУВАННІ ДІАБЕТУ (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 |
Czech Republic | 20021285 | C-Arylglukosidové inhibitory SGLT2 a jejich použití (C-Arylglukoside SGLT2 inhibitors and their use) | ⤷ 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 |
---|---|---|---|---|
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 | 588 | Finland | ⤷ Try a Trial | |
2139494 | 132020000000115 | Italy | ⤷ Try a Trial | PRODUCT NAME: SAXAGLIPTIN E DAPAGLIFLOZIN(QTERN); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1108, 20160719 |
1506211 | C20140021 00131 | Estonia | ⤷ Try a Trial | PRODUCT NAME: DAPAGLIFLOSIIN/METFORMIIN;REG NO/DATE: K(2014)308 (LOPLIK) 21.01.2014 |
1506211 | CA 2013 00019 | Denmark | ⤷ Try a Trial | |
1506211 | DO 136; 5005-2013 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: DAPAGLIFOZIN:REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112; FORMER OWNER: BRISTOL |
1506211 | CR 2014 00037 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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