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Serving leading biopharmaceutical companies globally:

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Generated: January 22, 2018

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Dapagliflozin propanediol; metformin hydrochloride - Generic Drug Details

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What are the generic sources for dapagliflozin propanediol; metformin hydrochloride and what is the scope of dapagliflozin propanediol; metformin hydrochloride patent protection?

Dapagliflozin propanediol; metformin hydrochloride
is the generic ingredient in one branded drug marketed by Astrazeneca Ab and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dapagliflozin propanediol; metformin hydrochloride has two hundred and twenty patent family members in forty-four countries.

There are twenty drug master file entries for dapagliflozin propanediol; metformin hydrochloride. One supplier is listed for this compound.
Summary for dapagliflozin propanediol; metformin hydrochloride
Pharmacology for dapagliflozin propanediol; metformin hydrochloride

US Patents and Regulatory Information for dapagliflozin propanediol; metformin 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 XIGDUO XR dapagliflozin propanediol; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-001 Oct 29, 2014 RX Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Astrazeneca Ab XIGDUO XR dapagliflozin propanediol; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-004 Oct 29, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Astrazeneca Ab XIGDUO XR dapagliflozin propanediol; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-004 Oct 29, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Astrazeneca Ab XIGDUO XR dapagliflozin propanediol; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-004 Oct 29, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Astrazeneca Ab XIGDUO XR dapagliflozin propanediol; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-001 Oct 29, 2014 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Astrazeneca Ab XIGDUO XR dapagliflozin propanediol; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-003 Oct 29, 2014 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Astrazeneca Ab XIGDUO XR dapagliflozin propanediol; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-002 Oct 29, 2014 RX Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Astrazeneca Ab XIGDUO XR dapagliflozin propanediol; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-004 Oct 29, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Astrazeneca Ab XIGDUO XR dapagliflozin propanediol; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-002 Oct 29, 2014 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Astrazeneca Ab XIGDUO XR dapagliflozin propanediol; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-002 Oct 29, 2014 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for dapagliflozin propanediol; metformin hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,535,715 Bilayer tablet formulations ➤ Subscribe
8,716,251 Pharmaceutical formulations containing an SGLT2 inhibitor ➤ Subscribe
8,221,786 Pharmaceutical formulations containing an SGLT2 inhibitor ➤ Subscribe
8,361,972 Pharmaceutical formulations containing an SGLT2 inhibitor ➤ Subscribe
9,050,258 Bilayer tablet formulations ➤ Subscribe
9,453,039 Crystal structures of SGLT2 inhibitors and processes for preparing same ➤ Subscribe
7,851,502 Pharmaceutical formulations containing an SGLT2 inhibitor ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for dapagliflozin propanediol; metformin hydrochloride

Supplementary Protection Certificates for dapagliflozin propanediol; metformin hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0677 Netherlands ➤ Subscribe 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
2014000071 Germany ➤ Subscribe PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116
2014026 Lithuania ➤ Subscribe PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
496 Luxembourg ➤ Subscribe 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
C0022 France ➤ Subscribe PRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/795/001 20121112
182 Luxembourg ➤ Subscribe PRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
2013000033 Germany ➤ Subscribe PRODUCT NAME: DAPAGLIFLOZIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112
1506211/01 Switzerland ➤ Subscribe PRODUCT NAME: DAPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC 65176 19.08.2014
2014026,C1506211 Lithuania ➤ Subscribe PRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
2013 008, C 1506211 Lithuania ➤ Subscribe PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
US Department of Justice
Cipla
Johnson and Johnson
Harvard Business School
Boehringer Ingelheim
Covington
Cantor Fitzgerald
Farmers Insurance

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 verifification 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.

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