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Last Updated: December 6, 2022

Empagliflozin; linagliptin - Generic Drug Details


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What are the generic sources for empagliflozin; linagliptin and what is the scope of patent protection?

Empagliflozin; linagliptin is the generic ingredient in two branded drugs marketed by Boehringer Ingelheim and is included in two NDAs. There are eighteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Empagliflozin; linagliptin has five hundred and fifty-seven patent family members in forty-seven countries.

One supplier is listed for this compound. There are three tentative approvals for this compound.

Summary for empagliflozin; linagliptin
Recent Clinical Trials for empagliflozin; linagliptin

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

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

See all empagliflozin; linagliptin clinical trials

Generic filers with tentative approvals for EMPAGLIFLOZIN; LINAGLIPTIN
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing25MG;5MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing25MG/5MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing10MG/5MGTABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for EMPAGLIFLOZIN; LINAGLIPTIN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
GLYXAMBI Tablets empagliflozin; linagliptin 10 mg/5 mg and 25 mg/5 mg 206073 9 2018-08-01

US Patents and Regulatory Information for empagliflozin; linagliptin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-002 Jan 30, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-002 Jan 30, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-002 Jan 27, 2020 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-004 Jan 27, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-004 Jan 27, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

EU/EMA Drug Approvals for empagliflozin; linagliptin

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Boehringer Ingelheim International GmbH Glyxambi empagliflozin, linagliptin EMEA/H/C/003833
Glyxambi, fixed dose combination of empagliflozin and linagliptin, is indicated in adults aged 18 years and older with type 2 diabetes mellitus:to improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the monocomponents of Glyxambi do not provide adequate glycaemic control;when already being treated with the free combination of empagliflozin and linagliptin.
Authorised no no no 2016-11-11
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for empagliflozin; linagliptin

Country Patent Number Title Estimated Expiration
Australia 2007247141 Uses of DPP-IV inhibitors See Plans and Pricing
Japan 5063356 See Plans and Pricing
Cyprus 1112948 See Plans and Pricing
Montenegro P59708 8-(3-amino-piperidin-1-il)-kasantini, njihovo dobijanje i njihova primjena kao farmaceutskih kompozicija (8-[3-AMINO-PIPERIDIN-1-YL]-XANTHINES, THE PRODUCTION THEREOF AND THE USE OF THE SAME AS MEDICAMENTS) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2006048427 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for empagliflozin; linagliptin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1730131 CA 2014 00054 Denmark See Plans and Pricing PRODUCT NAME: EMPAGLIFLOZIN OG SALTE DERAF, SAERLIGT EMPAGLIFLOZIN; REG. NO/DATE: EU1/14/930/001/018 20140522
1730131 PA2014035 Lithuania See Plans and Pricing PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522
2187879 122017000024 Germany See Plans and Pricing PRODUCT NAME: EMPAGLIFLOZIN MIT LINAGLIPTIN ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ HIERVON; REGISTRATION NO/DATE: EU/1/16/1146/001-018 20161111
2187879 2017/018 Ireland See Plans and Pricing PRODUCT NAME: COMBINATION OF: EMPAGLIFLOZIN; AND LINAGLIPTIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/16/1146 20161111
1730131 14C0074 France See Plans and Pricing PRODUCT NAME: EMPAGLIFLOZINE ET SES SELS, EN PARTICULIER L'EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930 20140527
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
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