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Last Updated: March 29, 2024

DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE - Generic Drug Details


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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

SponsorPhase
University of Erlangen-Nürnberg Medical SchoolPhase 4
Sabyasachi SenPhase 4
Zhujiang HospitalPhase 4

See all DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE clinical trials

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 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
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
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
>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

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

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