DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE - Generic Drug Details
✉ Email this page to a colleague
What are the generic drug 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 six patent family members in forty-eight countries.
One supplier is listed for this compound.
Summary for DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
International Patents: | 306 |
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 |
Zhujiang 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
Expired US Patents for DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
International Patents for DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Spain | 2950089 | ⤷ Try a Trial | |
Czech Republic | 20021285 | C-Arylglukosidové inhibitory SGLT2 a jejich použití (C-Arylglukoside SGLT2 inhibitors and their use) | ⤷ Try a Trial |
Spain | 2593582 | ⤷ Try a Trial | |
South Korea | 101493102 | ⤷ Try a Trial | |
Canada | 2486539 | C-ARYL GLUCOSIDES EN TANT QU'INHIBITEURS DE SGLT-2 ET METHODE CORRESPONDANTE (C-ARYL GLUCOSIDE SGLT2 INHIBITORS AND METHOD) | ⤷ Try a Trial |
Croatia | P20200753 | ⤷ Try a Trial | |
Canada | 2653344 | SOLVATES CRISTALLINS ET COMPLEXES DE DERIVES DE (IS)-1,5-ANHYDRO-L-C-{3-[(PHENYL)METHYL]PHENYL}-D-GLUCITOL AVEC DES ACIDES AMINES EN TANT QU'INHIBITEURS DE SGLT2 POUR LE TRAITEMENT DU DIABETE (CRYSTALLINE SOLVATES AND COMPLEXES OF (IS) -1, 5-ANHYDRO-1-C- (3- ( (PHENYL) METHYL) PHENYL) -D-GLUCITOL DERIVATIVES WITH AMINO ACIDS ASSGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES) | ⤷ 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 | PA 2013 008, C 1506211 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112 |
1506211 | 588 | Finland | ⤷ 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 | C01506211/02 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: DAPAGLIFLOZIN + METFORMIN; REGISTRATION NO/DATE: SWISSMEDIC 65377 16.07.2015 |
1506211 | 1390017-0 | Sweden | ⤷ Try a Trial | PRODUCT NAME: DAPAGLIFLOZIN OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/12/795/001 20121112 |
2139494 | LUC00176 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: SAXAGLIPTINE ET DAPAGLIFLOZINE; AUTHORISATION NUMBER AND DATE: EU/1/16/1108 20160719 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.