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.
Summary for EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
International Patents: | 485 |
US Patents: | 15 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 16 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
DailyMed Link: | EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE at DailyMed |
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
Sponsor | Phase |
---|---|
Medanta, The Medicity, India | N/A |
The First Affiliated Hospital with Nanjing Medical University | N/A |
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | N/A |
See all EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE clinical trials
Pharmacology for EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Drug Class | Biguanide Dipeptidyl Peptidase 4 Inhibitor Sodium-Glucose Cotransporter 2 Inhibitor |
Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors Sodium-Glucose Transporter 2 Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes 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 | 212614-001 | 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 | 212614-003 | 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 | 212614-003 | 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 | 212614-004 | 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 | |||
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 | |||
>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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Boehringer Ingelheim | TRIJARDY XR | empagliflozin; linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 212614-002 | Jan 27, 2020 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | TRIJARDY XR | empagliflozin; linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 212614-004 | Jan 27, 2020 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | TRIJARDY XR | empagliflozin; linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 212614-001 | Jan 27, 2020 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | TRIJARDY XR | empagliflozin; linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 212614-004 | Jan 27, 2020 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | TRIJARDY XR | empagliflozin; linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 212614-003 | Jan 27, 2020 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | TRIJARDY XR | empagliflozin; linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 212614-003 | Jan 27, 2020 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 3424926 | 8-[3-AMINO-PIPÉRIDINE-1-YL]-XANTHINE, LEUR FABRICATION ET LEUR UTILISATION EN TANT QUE MÉDICAMENT (8-[3-AMINO-PIPERIDIN-1-YL]-XANTHINS, THEIR PRODUCTION AND UTILISATION AS MEDICINE) | ⤷ Sign Up |
Mexico | 2011008172 | COMPOSICION FARMACEUTICA QUE COMPRENDE UN INHIBIDOR DE SGLT2, UN INHIBIDOR DE DPP-IV Y OPCIONALMENTE OTRO AGENTE ANTIDIABETICO, Y USOS DE LA MISMA. (PHARMACEUTICAL COMPOSITION COMPRISING A SGLT2 INHIBITOR, A DPP-IV INHIBITOR AND OPTIONALLY A FURTHER ANTIDIABETIC AGENT AND USES THEREOF.) | ⤷ Sign Up |
Mexico | 2013010187 | COMPOSICIONES FARMACEUTICAS QUE COMPRENDEN MERFORMINA Y UN INHIBIDOR DE DPP-4 O UN INHIBIDOR DE SGLT-2. (PHARMACEUTICAL COMPOSITIONS COMPRISING METFORMIN AND A DPP-4 INHIBITOR OR A SGLT-2 INHIBITOR.) | ⤷ Sign Up |
Japan | 5766661 | ⤷ Sign Up | |
Portugal | 1730131 | ⤷ Sign Up | |
Eurasian Patent Organization | 013079 | КРИСТАЛЛИЧЕСКАЯ ФОРМА 1-ХЛОР-4-(β-D-ГЛЮКОПИРАНОЗ-1-ИЛ)-2-[4-((S)-ТЕТРАГИДРОФУРАН-3-ИЛОКСИ)БЕНЗИЛ]БЕНЗОЛА, СПОСОБ ЕЕ ПОЛУЧЕНИЯ И ЕЕ ПРИМЕНЕНИЕ ДЛЯ ПРИГОТОВЛЕНИЯ ЛЕКАРСТВЕННЫХ СРЕДСТВ (CRYSTALLINE FORM OF 1-CHLORO-4(&bgr;-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 |
>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 | 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 |
1730131 | C 2014 039 | Romania | ⤷ Sign Up | PRODUCT NAME: EMPAGLIFOZIN SI SARURILE ACESTUIA, IN SPECIAL EMPAGLIFOZIN(1S)-1,5-ANHIDRO-1-C-{4-CLORO-3-[(4-{[(3S)-OXOLAN-3-IL]OXI}FENIL)METIL}-D-GLUCITOL; NATIONAL AUTHORISATION NUMBER: EU/1/14/930; DATE OF NATIONAL AUTHORISATION: 20140522; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/930; DATE OF FIRST AUTHORISATION IN EEA: 20140522 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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