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Last Updated: March 28, 2024

EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE - Generic Drug Details


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What are the generic drug sources for empagliflozin; linagliptin; metformin hydrochloride and what is the scope of freedom to operate?

Empagliflozin; linagliptin; metformin hydrochloride is the generic ingredient in one branded drug marketed by Boehringer Ingelheim and is included in one NDA. There are fifteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Empagliflozin; linagliptin; metformin hydrochloride has four hundred and eighty-four patent family members in forty-eight countries.

One supplier is listed for this compound.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Generic Entry Date for EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, EXTENDED RELEASE;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 EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolN/A
Wuxi People's HospitalN/A
The First Affiliated Hospital with Nanjing Medical UniversityN/A

See all EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE clinical trials

Pharmacology for EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Paragraph IV (Patent) Challenges for EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TRIJARDY XR Extended-release Tablets empagliflozin; linagliptin; metformin hydrochloride 5 mg/2.5 mg/1 g, 10 mg/5 mg/1 g, 12.5 mg/5 mg/1 g, 25 mg/5 mg/1 g 212614 1 2020-05-26

US Patents and Regulatory Information for EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-002 Jan 27, 2020 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-002 Jan 27, 2020 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-004 Jan 27, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-002 Jan 27, 2020 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-002 Jan 27, 2020 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-004 Jan 27, 2020 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 EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE

International Patents for EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Country Patent Number Title Estimated Expiration
New Zealand 564768 8-[3-amino-piperidin-1-yl]-xanthines, the production thereof and the use of the same as medicaments ⤷  Try a Trial
Slovenia 2981271 ⤷  Try a Trial
Peru 20100232 PROCEDIMIENTO PARA PREPARAR 8-(3-AMINO-PIPERIDIN-1-IL)-XANTINAS QUIRALES ⤷  Try a Trial
Australia 2005300559 Method for producing chiral 8-(3-amino-piperidin-1-yl)-xanthines ⤷  Try a Trial
Japan 2011516456 ⤷  Try a Trial
Taiwan 200635599 Glucopyranosyl-substituted benzene derivatives, medicaments containing such compounds, their use and process for their manufacture ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2187879 PA2017014 Lithuania ⤷  Try a Trial PRODUCT NAME: EMPAGLIFLOZINO IR LINAGLIPTINO DERINYS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/16/1146/001 - EU/1/16/1146/018 20161111
1532149 CR 2011 00030 Denmark ⤷  Try a Trial PRODUCT NAME: LINAGLIPTIN OG SALTE DERAF; NAT. REG. NO/DATE: EU/1/11/707/001-011 20110830; FIRST REG. NO/DATE: EU EU/1/11/707/001-0011 20110830
1730131 C01730131/03 Switzerland ⤷  Try a Trial PRODUCT NAME: EMPAGLIFLOZIN UND LINAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66132 29.03.2017
1730131 2014/055 Ireland ⤷  Try a Trial PRODUCT NAME: EMPAGLIFLOZIN AND SALTS THEREOF, IN PARTICULAR EMPAGLIFLOZIN ((1S)-1,5- ANHYDRO-1-C-(4-CHLORO-3-((4-(((3S)-OXOLAN-3-YL)OXY))PHENYL)METHYL)PHENYL)- D-GLUCITOL); REGISTRATION NO/DATE: EU/1/14/930 20140522
1730131 1490061-7 Sweden ⤷  Try a Trial PERIOD OF VALIDITY (FROM - UNTIL): 20250312 - 20290526
1730131 PA2014035,C1730131 Lithuania ⤷  Try a Trial PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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