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: | 14 |
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 |
---|---|
Wuxi People's Hospital | 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 |
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
Expired US Patents for EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
International Patents for EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Poland | 403104 | Sposób otrzymywania kompozycji farmaceutycznej zawierajacej pochodne 8-[3-aminopiperydyn-1-ylo]ksantyny (Method for preparing a pharmaceutical composition comprising derivatives of 8 - [3-Amino-piperidin-1-yl]-xanthine) | ⤷ Try a Trial |
Norway | 20140127 | ⤷ Try a Trial | |
Peru | 20091730 | FORMULACIONES QUE COMPRENDEN UN INHIBIDOR DE DPP4 | ⤷ Try a Trial |
Japan | 2016000756 | メトホルミン及びDPP−4阻害剤又はSGLT−2阻害剤を含む医薬組成物 (PHARMACEUTICAL COMPOSITION COMPRISING METFORMIN AND DPP-4 INHIBITOR OR SGLT-2 INHIBITOR) | ⤷ Try a Trial |
Ukraine | 84275 | 8-[3-АМИНОПИПЕРИДИН-1-ИЛ]КСАНТИНЫ, СПОСОБ ИХ ПОЛУЧЕНИЯ И ИХ ПРИМЕНЕНИЕ КАК ЛЕКАРСТВЕННЫХ СРЕДСТВ;8-[3-АМІНОПІПЕРИДИН-1-ІЛ]КСАНТИНИ, СПОСІБ ЇХ ОДЕРЖАННЯ ТА ЇХ ЗАСТОСУВАННЯ ЯК ЛІКАРСЬКИХ ЗАСОБІВ (8-[3-AMINO-PIPERIDIN-1-YL]-XANTHINES, THE PREPARATION THEREOF AND THEIR USE AS PHARMACEUTICAL COMPOSITIONS) | ⤷ Try a Trial |
>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 |
---|---|---|---|---|
2187879 | PA2017014,C2187879 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: EMPAGLIFLOZINO IR LINAGLIPTINO ARBA JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS DERINYS; REGISTRATION NO/DATE: EU/1/16/1146/001 - EU/1/16/1146/018 20161111 |
1532149 | 92128 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3, 7-DIHYDROPURIN-2, 6-DION, LES ENANTIOMERES ET LEURS SELS, EN PARTICULIER LA LINAGLIPTINE COMBINEE AVEC DU CHLORHYDRATE DE METFORMINE. LINAGLIPTINE |
1730131 | C20140033 00134 | Estonia | ⤷ Try a Trial | PRODUCT NAME: EMPAGLIFLOSIIN;REG NO/DATE: EU/1/14/930 27.05.2014 |
1730131 | PA2014035,C1730131 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522 |
2187879 | 1790019-2 | Sweden | ⤷ Try a Trial | PRODUCT NAME: COMBINATION OF EMPAGLIFLOZIN AND LINAGLIPTIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/16/1146 20161115 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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