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 |
---|---|---|---|
Japan | 2011148819 | NOVEL PHARMACEUTICAL FORMULATION CONTAINING BIGUANIDE AND THIAZOLIDINEDIONE DERIVATIVE | ⤷ Try a Trial |
Colombia | 5700740 | PREPARACION SOLIDA | ⤷ Try a Trial |
Ukraine | 91852 | ФАРМАЦЕВТИЧЕСКАЯ ДОЗИРОВАННАЯ ФОРМА, КОТОРАЯ СОДЕРЖИТ МЕТФОРМИН И ПИОГЛИТАЗОН КАК АКТИВНЫЕ МЕДИКАМЕНТЫ;ФАРМАЦЕВТИЧНА ДОЗОВАНА ФОРМА, ЯКА МІСТИТЬ МЕТФОРМІН ТА ПІОГЛІТАЗОН ЯК АКТИВНІ МЕДИКАМЕНТИ (PHARMACEUTICAL FORMULATION CONTAINING A METFORMIN AND A PIOGLITAZONE AS ACTIVE MEDICAMENTS) | ⤷ Try a Trial |
Japan | 2007505903 | ⤷ Try a Trial | |
European Patent Office | 1539144 | NOUVELLE PREPARATION PHARMACEUTIQUE CONTENANT UN BIGUANIDE ET UN DERIVE DE LA THIAZOLIDINEDIONE (MULTISTAGE FORMULATION CONTAINING A BIGUANIDE AND A 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 |
---|---|---|---|---|
1412357 | PA2008013 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REG. NO/DATE: EU/1/08/455/001-014 20080716 |
1412357 | 77 5006-2008 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: SITAGLIPTIN A METFORMIN; NAT. REG.NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REG.:CH 58450 01-03 20080408 |
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 |
1506211 | 122014000070 | Germany | ⤷ Try a Trial | PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, WIE DURCH DAS GRUNDPATENT GESCHUETZT; REGISTRATION NO/DATE: EU/1/13/900 20140116 |
2498758 | 2090013-0 | Sweden | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION OF METFORMIN HYDROCHLORIDE, SAXAGLIPTIN OR A PHARMACEUTICALLY ACCEPABLE SALT THEREOF, AND DAPAGLIFLOZIN OR PH ARMACEUTICALLY ACCEPTABLE SOLVATE THEREOF; REG. NO/DATE: EU/1/19/1401 20191113 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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