You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 21, 2024

EMPAGLIFLOZIN; LINAGLIPTIN - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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

Empagliflozin; linagliptin is the generic ingredient in two branded drugs marketed by Boehringer Ingelheim and is included in two NDAs. There are nineteen 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 sixty-two 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
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for EMPAGLIFLOZIN; LINAGLIPTIN
Generic Entry Date for EMPAGLIFLOZIN; LINAGLIPTIN*:
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 EMPAGLIFLOZIN; LINAGLIPTIN

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

SponsorPhase
Diabetes & Endocrinology FoundationN/A
Medanta, The Medicity, IndiaN/A
Wuxi People's HospitalN/A

See all EMPAGLIFLOZIN; LINAGLIPTIN clinical trials

Generic filers with tentative approvals for EMPAGLIFLOZIN; LINAGLIPTIN
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up25MG;5MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up25MG/5MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up10MG/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 206073-001 Jan 30, 2015 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-003 Jan 27, 2020 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-001 Jan 27, 2020 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-004 Jan 27, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-001 Jan 27, 2020 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 EMPAGLIFLOZIN; LINAGLIPTIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-001 Jan 30, 2015 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-002 Jan 30, 2015 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-002 Jan 30, 2015 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-001 Jan 30, 2015 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-001 Jan 30, 2015 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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
South Korea 20050058375 8-[3-AMINO-PIPERIDIN-1-YL]-XANTHINES, THE PRODUCTION THEREOF AND THE USE OF THE SAME AS MEDICAMENTS ⤷  Sign Up
Poland 2277509 ⤷  Sign Up
Mexico 2020009911 USOS DE INHIBIORES DE DPP IV. (USES OF DPP-IV INHIBITORS.) ⤷  Sign Up
Brazil 0313648 8-[3-amino-piperidin-1-il]-xantinas, a preparação das mesmas e uso das mesmas como medicamento ⤷  Sign Up
Argentina 087287 8-[3-AMINO-PIPERIDIN-1-IL]-XANTINAS, SU PREPARACION Y SU UTILIZACION COMO MEDICAMENTOS ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for EMPAGLIFLOZIN; LINAGLIPTIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1532149 PA2012022 Lithuania ⤷  Sign Up PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
2187879 276 10-2017 Slovakia ⤷  Sign Up PRODUCT NAME: EMPAGLIFLOZIN/LINAGLIPTIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1146 20161115
2187879 17C1016 France ⤷  Sign Up PRODUCT NAME: COMBINAISON D'EMPAGLIFLOZINE ET DE LINAGLIPTINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/16/1146 20161115
1532149 621 Finland ⤷  Sign Up
1532149 C300569 Netherlands ⤷  Sign Up PRODUCT NAME: LINAGLIPTINE, DESGEWENST IN DE VORM VAN EEN ZOUT, IN COMBINATIE MET METFORMINEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/12/780/001-028 20120720
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.