METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE - Generic Drug Details
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What are the generic sources for metformin hydrochloride; pioglitazone hydrochloride and what is the scope of patent protection?
Metformin hydrochloride; pioglitazone hydrochloride
is the generic ingredient in three branded drugs marketed by Takeda Pharms Usa, Aurobindo Pharma Ltd, Chartwell Rx, Macleods Pharms Ltd, Mylan, Teva Pharms Usa, and Torrent Pharms Ltd, and is included in eight NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Metformin hydrochloride; pioglitazone hydrochloride has one hundred and thirteen patent family members in thirty-two countries.
Six suppliers are listed for this compound.
Summary for METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
International Patents: | 113 |
US Patents: | 4 |
Tradenames: | 3 |
Applicants: | 7 |
NDAs: | 8 |
Finished Product Suppliers / Packagers: | 6 |
Clinical Trials: | 155 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE |
DailyMed Link: | METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Minnesota | Phase 2 |
Nanjing First Hospital, Nanjing Medical University | Phase 3 |
Affiliated Hospital of Nantong University | Phase 1 |
See all METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE clinical trials
Pharmacology for METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ACTOPLUS MET XR | Extended-release Tablets | metformin hydrochloride; pioglitazone hydrochloride | 15 mg/1000 mg and 30 mg/1000 mg | 022024 | 1 | 2011-09-23 |
US Patents and Regulatory Information for METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
Expired US Patents for METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
International Patents for METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 2537665 | NOUVELLE PREPARATION PHARMACEUTIQUE CONTENANT UN BIGUANIDE ET UN DERIVE THIAZOLIDINEDIONE (NOVEL PHARMACEUTICAL FORMULATION CONTAINING A BIGUANIDE AND A THIAZOLIDINEDIONE DERIVATIVE) | ⤷ Try a Trial |
Japan | 2008208141 | SOLID PHARMACEUTICAL PREPARATION | ⤷ Try a Trial |
China | 101222912 | Novel pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative | ⤷ Try a Trial |
Eurasian Patent Organization | 015244 | ФАРМАЦЕВТИЧЕСКАЯ ДОЗИРОВАННАЯ ФОРМА (ВАРИАНТЫ) С КОНТРОЛИРУЕМЫМ ВЫСВОБОЖДЕНИЕМ МЕТФОРМИНА В КОМБИНАЦИИ С ГИДРОХЛОРИДОМ ПИОГЛИТАЗОНА (PHARMACEUTICAL DOSAGE FORM (EMBODIMENTS) WITH CONTROLLED RELEASE OF METFORMIN IN COMBINATION WITH HYDROCHLORIDE PIOGLITAZONE) | ⤷ Try a Trial |
Brazil | PI0609550 | formulação farmacêutica contendo uma biguanida e um derivado de tiazolidinediona | ⤷ Try a Trial |
Japan | 2011148819 | NOVEL PHARMACEUTICAL FORMULATION CONTAINING BIGUANIDE AND THIAZOLIDINEDIONE DERIVATIVE | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1506211 | PA2014026 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116 |
1506211 | 42/2014 | Austria | ⤷ Try a Trial | PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON UND METFORMIN UND EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON; REGISTRATION NO/DATE: EU/1/13/900 (MITTEILUNG) 20140121 |
1506211 | 179 5017-2014 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: KOMBINACIA DAPAGLIFLOZINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI A METFORMINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI; REGISTRATION NO/DATE: EU/1/13/900/001 - EU/1/13/900/012 20140116 |
1506211 | CR 2014 00037 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116 |
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 |
2498758 | CR 2020 00017 | Denmark | ⤷ Try a Trial | PRODUCT NAME: METFORMIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; SAXAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SOLVAT DERAF; REG. NO/DATE: EU/1/19/1401 20191113 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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