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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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
Shenzhen Sixth People's 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

Anatomical Therapeutic Chemical (ATC) Classes for dapagliflozin; saxagliptin hydrochloride

A10BH	Dipeptidyl peptidase 4 (DPP-4) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

A10BK	Sodium-glucose co-transporter 2 (SGLT2) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

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

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Glossary

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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	⤷ 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	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
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-002	May 2, 2019		RX	Yes	No	⤷ 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	209091-002	May 2, 2019	⤷ 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
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

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Country	Patent Number	Title	Estimated Expiration
Russian Federation	2262507	С-АРИЛГЛЮКОЗИДНЫЕ ИНГИБИТОРЫ SGLT2 (C-ARYLGLUCOSIDE INHIBITORS OF SGLT-2)	⤷ Sign Up
Hong Kong	1068214	C-aryl glucoside sglt2 inhibitors and method	⤷ Sign Up
European Patent Office	4245299	Formulations pharmaceutiques contenant un hydrate de propylèneglycol dapagliflozine (Pharmaceutical formulations containing dapagliflozin propylene glycol hydrate)	⤷ Sign Up
Argentina	040032	C-ARIL-GLUCOSIDOS COMO INHIBIDORES DE SGLT2 Y METODO	⤷ Sign Up
European Patent Office	3363807	COMPOSITION PHARMACEUTIQUE COMPRENANT SOLVATE DE (S)-PROPYLENE GLYCOL DE (2S,3R,4S,5S,6R)-2-[4-CHLORO-3-(4-ÉTHOXY-BENZYL)-PHÉNYL]-6-HYDROXYMÉTHYL-2-MÉTHOXY-TETRAHYDRO-PYRAN-3,4,5-TRIOL CRISTALLINE (PHARMACEUTICAL COMPOSITION COMPRISING CRYSTALLINE (2S,3R,4S,5S,6R)-2-[4-CHLORO-3-(4-ETHOXY-BENZYL)-PHENYL]-6-HYDROXYMETHYL-2-METHOXY-TETRAHYDRO-PYRAN-3,4,5-TRIOL (S)-PROPYLENE GLYCOL SOLVATE)	⤷ Sign Up
Czech Republic	20021285	C-Arylglukosidové inhibitory SGLT2 a jejich použití (C-Arylglukoside SGLT2 inhibitors and their use)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for dapagliflozin; saxagliptin hydrochloride

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	PA2013008	Lithuania	⤷ Sign Up	PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
1506211	588	Finland	⤷ Sign Up
1506211	C 2014 029	Romania	⤷ Sign Up	PRODUCT NAME: COMBINATIE DE DAPAGLIFLOZIN SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTUIA SI METFORMINA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/900; DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/900; DATE OF FIRST AUTHORISATION IN EEA: 20140116
1506211	1390017-0	Sweden	⤷ Sign Up	PRODUCT NAME: DAPAGLIFLOZIN OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/12/795/001 20121112
1506211	92496	Luxembourg	⤷ Sign Up	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
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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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.