ACTOPLUS MET XR Drug Patent Profile
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Which patents cover Actoplus Met Xr, and when can generic versions of Actoplus Met Xr launch?
Actoplus Met Xr is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has seventy-two patent family members in twenty-five countries.
The generic ingredient in ACTOPLUS MET XR is metformin hydrochloride; pioglitazone hydrochloride. There are forty-nine drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; pioglitazone hydrochloride profile page.
DrugPatentWatch® Generic Entry Outlook for Actoplus Met Xr
There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for ACTOPLUS MET XR
International Patents: | 72 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 2 |
Clinical Trials: | 3 |
Patent Applications: | 36 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ACTOPLUS MET XR |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ACTOPLUS MET XR |
DailyMed Link: | ACTOPLUS MET XR at DailyMed |
Recent Clinical Trials for ACTOPLUS MET XR
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Cancer Institute (NCI) | Phase 2 |
Torrent Pharmaceuticals Limited | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for ACTOPLUS MET XR
Paragraph IV (Patent) Challenges for ACTOPLUS MET XR
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 ACTOPLUS MET XR
ACTOPLUS MET XR is protected by two US patents.
Patents protecting ACTOPLUS MET XR
Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Expired US Patents for ACTOPLUS MET XR
International Patents for ACTOPLUS MET XR
See the table below for patents covering ACTOPLUS MET XR around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Denmark | 171614 | ⤷ Try a Trial | |
South Korea | 20130039344 | PHARMACEUTICAL TABLET | ⤷ Try a Trial |
Czech Republic | 9601811 | ⤷ Try a Trial | |
Australia | 2003272504 | NOVEL PHARMACEUTICAL FORMULATION CONTAINING A BIGUANIDE AND A THIAZOLIDINEDIONE DERIVATIVE | ⤷ Try a Trial |
European Patent Office | 1764110 | ⤷ Try a Trial | |
Costa Rica | 9355 | FORMULACION FARMACEUTICA NOVEDOSA QUE CONTIENE UNA BIGUANIDA Y UN DERIVADO DE TIAZOLIDINADIONA | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ACTOPLUS MET XR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1174135 | C01174135/01 | Switzerland | ⤷ Try a Trial | FORMER REPRESENTATIVE: BOHEST AG, CH |
2498758 | 16/2020 | Austria | ⤷ Try a Trial | PRODUCT NAME: METFORMIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; SAXAGLIPTIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; DAPAGLIFLOZIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/19/1401 (MITTEILUNG) 20191113 |
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 |
1174135 | SPC/GB10/011 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: THE COMBINATION OF PIOGLITAZONE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY THE HYDROCHLORIDE SALT, AND GLIMEPIRIDE.; REGISTERED: UK EU/1/06/366/001 20070108; UK EU/1/06/366/002 20070108; UK EU/1/06/366/003 20070108; UK EU/1/06/366/004 20070108; UK EU/1/06/366/005 20070108; UK EU/1/06/366/006 20070108; UK EU/1/06/366/019 20070108; UK EU/1/06/366/020 20070108; UK EU/1/06/366/021 20070108; UK EU/1/06/366/022 20070108; UK EU/1/06/366/013 20070108; UK EU/1/06/366/014 20070108; UK EU/1/06/366/015 20070108; UK EU/1/06/366/016 20070108; UK EU/1/06/366/017 20070108; UK EU/1/06/366/018 20070108; UK EU/1/06/366/007 20070108; UK EU/1/06/366/008 20070108; UK EU |
1506211 | C300677 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121 |
1261586 | 2012C/016 | Belgium | ⤷ Try a Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |