Metformin hydrochloride; pioglitazone hydrochloride - Generic Drug Details
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What are the generic drug sources for metformin hydrochloride; pioglitazone hydrochloride and what is the scope of freedom to operate?
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.
Five 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: | 5 |
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 | 2014196314 | ビグアニドおよびチアゾリジンジオン誘導体を含む新規の医薬製剤 (NOVEL PHARMACEUTICAL FORMULATION CONTAINING BIGUANIDE AND THIAZOLIDINEDIONE DERIVATIVE) | ⤷ Sign Up |
Australia | 2003272504 | NOVEL PHARMACEUTICAL FORMULATION CONTAINING A BIGUANIDE AND A THIAZOLIDINEDIONE DERIVATIVE | ⤷ Sign Up |
Peru | 20061389 | FORMULACION FARMACEUTICA QUE CONTIENE BIGUANIDA Y UN DERIVADO DE TIAZOLIDINADIONA | ⤷ Sign Up |
Portugal | 1867324 | ⤷ Sign Up | |
World Intellectual Property Organization (WIPO) | 2006106815 | ⤷ Sign Up | |
>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 | CA 2008 00035 | Denmark | ⤷ Sign Up | PRODUCT NAME: SITAGLIPTIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER MONOPHOSPHAT, METFORMIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER HYDROCHLORID |
1506211 | 42/2014 | Austria | ⤷ Sign Up | 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 |
1261586 | 2012C/016 | Belgium | ⤷ Sign Up | PRODUCT NAME: UNE COMBINAISON DE PRODUITS DE SAXAGLIPTINE ET DE METFORMINE AINSI QUE TOUT SELS PHARMACEUTIQUEMENT ACCEPTABLES, DONT LES SELS DE CHLORHYDRATE DE SAXAGLIPTINE ET DE METFORMINE; AUTHORISATION NUMBER AND DATE: EU/1/11/731/001 20111128 |
2498758 | PA2020003,C2498758 | Lithuania | ⤷ Sign Up | PRODUCT NAME: METFORMINO HIDROCHLORIDAS; SAKSAGLIPTINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; DAPAGLIFLOZINAS ARBA FARMACINIU POZIURIU PRIIMTINAS JO SOLVATAS; REGISTRATION NO/DATE: EU/1/19/1401 20191111 |
1532149 | 92128 | Luxembourg | ⤷ 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, LES ENANTIOMERES ET LEURS SELS, EN PARTICULIER LA LINAGLIPTINE COMBINEE AVEC DU CHLORHYDRATE DE METFORMINE. LINAGLIPTINE |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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