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Last Updated: July 29, 2025

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 twenty-one patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Empagliflozin; linagliptin has six hundred and six patent family members in forty-eight 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
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
⤷  Try for Free⤷  Try for Free25MG;5MGTABLET;ORAL
⤷  Try for Free⤷  Try for Free25MG/5MGTABLET;ORAL
⤷  Try for Free⤷  Try for Free10MG/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

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-001 Jan 30, 2015 RX Yes No 12,115,179 ⤷  Try for Free ⤷  Try for Free
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-001 Jan 30, 2015 RX Yes No 8,673,927*PED ⤷  Try for Free Y ⤷  Try for Free
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-001 Jan 30, 2015 RX Yes No 9,949,998 ⤷  Try for Free ⤷  Try for Free
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-002 Jan 27, 2020 RX Yes No 10,258,637*PED ⤷  Try for Free Y ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 4 of 4 entries

Expired US Patents for empagliflozin; linagliptin

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-002 Jan 30, 2015 6,890,898 ⤷  Try for Free
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-001 Jan 30, 2015 8,178,541 ⤷  Try for Free
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-002 Jan 30, 2015 8,178,541 ⤷  Try for Free
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-001 Jan 30, 2015 6,303,661 ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 4 of 4 entries

EU/EMA Drug Approvals for empagliflozin; linagliptin

CompanyDrugnameInnProduct Number / IndicationStatusGenericBiosimilarOrphanMarketing AuthorisationMarketing 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
Showing 1 to 1 of 1 entries

International Patents for empagliflozin; linagliptin

CountryPatent NumberTitleEstimated Expiration
Chile 2015002940 Usos terapéuticos de empaglifozina. ⤷  Try for Free
Japan 6139004 ⤷  Try for Free
Peru 20100232 PROCEDIMIENTO PARA PREPARAR 8-(3-AMINO-PIPERIDIN-1-IL)-XANTINAS QUIRALES ⤷  Try for Free
South Korea 20150082668 DPP-IV 억제제의 용도 (USE OF DPP-IV INHIBITORS) ⤷  Try for Free
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 4 of 4 entries

Supplementary Protection Certificates for empagliflozin; linagliptin

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
1532149 1190035-4 Sweden ⤷  Try for Free PERIOD OF VALIDITY (FROM - UNTIL): 20230819 - 20260829
2187879 300872 Netherlands ⤷  Try for Free PRODUCT NAME: COMBINATIE VAN EMPAGLIFLOZINE EN LINAGLIPTINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/16/1146 20161115
1532149 91889 Luxembourg ⤷  Try for Free 91889, EXPIRES: 20260824
1532149 PA2011013,C1532149 Lithuania ⤷  Try for Free PRODUCT NAME: LINAGLIPTINUM; REGISTRATION NO/DATE: EU/1/11/707/001, 2011-08-24 EU/1/11/707/002, 2011-08-24 EU/1/11/707/003, 2011-08-24 EU/1/11/707/004, 2011-08-24 EU/1/11/707/005, 2011-08-24 EU/1/11/707/006, 2011-08-24 EU/1/11/707/007, 2011-08-24 EU/1/11/707/008, 2011-08-24 EU/1/11/707/00 2011082
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 4 of 4 entries

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