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Last Updated: November 7, 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-five 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
Medanta, The Medicity, IndiaN/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; 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 212614-004 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 212614-002 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 212614-002 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 212614-003 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 212614-002 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
>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
Hungary E044308 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2009121945 ⤷  Sign Up
Ukraine 91546 КРИСТАЛІЧНА ФОРМА 1-ХЛОР-4-(β-D-ГЛЮКОПІРАНОЗ-1-ИЛ)-2-[4-((S)-ТЕТРАГІДРОФУРАН-3-ІЛОКСИ)-БЕНЗИЛ]-БЕНЗОЛУ, СПОСІБ ЇЇ ОДЕРЖАННЯ ТА ЇЇ ЗАСТОСУВАННЯ ПРИ ПРИГОТУВАННІ ЛІКАРСЬКИХ ЗАСОБІВ[КРИСТАЛЛИЧЕСКАЯ ФОРМА 1-ХЛОР-4-(b-D-ГЛЮКОПИРАНОЗ-1- ИЛ)-2-[4-((S)- ТЕТРАГИДРОФУРАН-3-ИЛОКСИ)-БЕНЗИЛ]-БЕНЗОЛА, СПОСОБ ЕЕ ПОЛУЧЕНИЯ И ЕЕ ПРИМЕНЕНИЕ ПРИ ПРИГОТАВЛЕНИИ ЛЕКАРСТВЕННЫХ СРЕДСТВ (CRYSTALLINE FORM OF 1-CHLORO-4-(Я-D-GLUCOPYRANOS-1-YL)-2-[4-((S)-TETRAHYDROFURAN-3-YLOXY)-BENZYL]-BENZENE, A METHOD FOR ITS PREPARATION AND THE USE THEREOF FOR PREPARING MEDICAMENTS) ⤷  Sign Up
Serbia 58097 TERAPEUTSKE PRIMENE EMPAGLIFLOZINA (THERAPEUTIC USES OF EMPAGLIFLOZIN) ⤷  Sign Up
Spain 2696124 ⤷  Sign Up
Eurasian Patent Organization 201001577 ИНГИБИТОР ДПП-4 В КОМБИНАЦИИ С ДОПОЛНИТЕЛЬНЫМ ПРОТИВОДИАБЕТИЧЕСКИМ АГЕНТОМ, ТАБЛЕТКИ, ВКЛЮЧАЮЩИЕ УКАЗАННЫЕ КОМПОЗИЦИИ, ИХ ПРИМЕНЕНИЕ И СПОСОБ ИХ ПОЛУЧЕНИЯ ⤷  Sign Up
Argentina 067970 COMPOSICION FARMACEUTICA QUE COMPRENDE UN DERIVADO DE BENCENO SUSTITUIDO CON GLUCOPIRANOSILO ⤷  Sign Up
>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
1532149 621 Finland ⤷  Sign Up
1532149 8/2012 Austria ⤷  Sign Up PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION UND DESSEN SALZE, INSBES. LINAGLIPTIN; REGISTRATION NO/DATE: EU/1/11/707/001-011 (MITTEILUNG) 20110830
1730131 1490061-7 Sweden ⤷  Sign Up PERIOD OF VALIDITY (FROM - UNTIL): 20250312 - 20290526
1532149 C 2012 003 Romania ⤷  Sign Up PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-IL)-7-BUT-2-INIL-3-METIL-1-(4-METILCHINAZOLIN-2-ILMETIL)3,7-DIHIDROPURIN-2,6-DIONA, ENANTIOMERII SI SARURILE LOR IN SPECIAL LINAGLIPTIN - LINAGLIPTIN, ENANTIOMERIISI SARURILE ACCEPTABILE FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/707/001 - RO EU/1/11/707/011; DATE OF NATIONAL AUTHORISATION: 20110824; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/707/001 - EU/1/11/707/011; DATE OF FIRST AUTHORISATION IN EEA: 20110824
1532149 PA2011013,C1532149 Lithuania ⤷  Sign Up 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
1730131 PA2014035 Lithuania ⤷  Sign Up PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522
2187879 PA2017014 Lithuania ⤷  Sign Up 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.