DrugPatentWatch Database Preview
ACTOPLUS MET Drug Profile
When do Actoplus Met patents expire, and what generic alternatives are available?
Actoplus Met is a drug marketed by Takeda Pharms Usa and is included in two NDAs. There are nine patents protecting this drug and two Paragraph IV challenges.
This drug has forty-one patent family members in twenty-five countries.
The generic ingredient in ACTOPLUS MET 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.
Summary for ACTOPLUS MET
| International Patents: | 41 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 3 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ACTOPLUS MET |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ACTOPLUS MET |
| DailyMed Link: | ACTOPLUS MET at DailyMed |
Recent Clinical Trials for ACTOPLUS MET
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Cancer Institute (NCI) | Phase 2 |
| Torrent Pharmaceuticals Limited | Phase 1 |
Recent Litigation for ACTOPLUS MET
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Takeda Pharmaceutical Company Limited v. Mylan, Inc. | 2012-01-03 |
| Takeda Pharmaceutical Company Limited v. Hetero Drugs Limited | 2011-11-16 |
| Takeda Pharmaceutical Company Limited v. Accord Healthcare, Inc. | 2011-09-12 |
Pharmacology for ACTOPLUS MET
Synonyms for ACTOPLUS MET
| 737811-27-7 |
| Actoplus Met XR |
| Actoplus metformin |
| LS-188012 |
| Metformin hydrochloride mixture with pioglitazone hydrochloride |
| Metformin mixture with pioglitazone |
| Pioglitazone hydrochloride and metformin hydrochloride |
| Pioglitazone hydrochloride mixture with Metformin hydrochloride |
| Pioglitazone mixture with metformin |
US Patents and Regulatory Information for ACTOPLUS MET
Expired US Patents for ACTOPLUS MET
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Takeda Pharms Usa | ACTOPLUS MET | metformin hydrochloride; pioglitazone hydrochloride | TABLET;ORAL | 021842-001 | Aug 29, 2005 | Start Trial | Start Trial |
| Takeda Pharms Usa | ACTOPLUS MET | metformin hydrochloride; pioglitazone hydrochloride | TABLET;ORAL | 021842-001 | Aug 29, 2005 | Start Trial | Start Trial |
| Takeda Pharms Usa | ACTOPLUS MET | metformin hydrochloride; pioglitazone hydrochloride | TABLET;ORAL | 021842-002 | Aug 29, 2005 | Start Trial | Start Trial |
| Takeda Pharms Usa | ACTOPLUS MET | metformin hydrochloride; pioglitazone hydrochloride | TABLET;ORAL | 021842-002 | Aug 29, 2005 | Start Trial | Start Trial |
| Takeda Pharms Usa | ACTOPLUS MET | metformin hydrochloride; pioglitazone hydrochloride | TABLET;ORAL | 021842-002 | Aug 29, 2005 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ACTOPLUS MET
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Poland | 376176 | Start Trial |
| Russian Federation | 2357757 | Start Trial |
| South Korea | 100820609 | Start Trial |
| Denmark | 1561472 | Start Trial |
| European Patent Office | 1561472 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ACTOPLUS MET
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1261586 | 2012C/016 | Belgium | Start 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 |
| 1412357 | C 2008 016 | Romania | Start Trial | PRODUCT NAME: SITAGLIPTIN OPTIONAL SUB FORMA DE SARE ACCEPTABILAFARMACEUTIC IN SPECIAL MONOFOSFAT + METFORMIN OPTIONAL SUB FORMA DE SARE ACCEPTABILA FARMACEUTIC IN SPECIALCLORHIDRAT; NATIONAL AUTHORISATION NUMBER: RO EU/1/08/455/001 - RO EU/1/08/455/014; DATE OF NATIONAL AUTHORISATION: 20080716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): CH 58450 01, CH 58450 02, CH 58450 03; DATE OF FIRST AUTHORISATION IN EEA: 20080408 |
| 1506211 | CR 2014 00037 | Denmark | Start 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 |
| 1261586 | 12C0028 | France | Start Trial | PRODUCT NAME: ASSOCIATION COMPRENANT LA SAXAGLIPTINE OU UN DE SES SELS ET LA METFORMINE OU UN DE SES SELS, Y COMPRIS L'ASSOCIATION CHLORHYDRATE DE SAXAGLIPTINE ET CHLORHYDRATE DE METFORMINE; REGISTRATION NO/DATE: EU/1/11/731/001 20111124 |
| 1532149 | 92128 | Luxembourg | Start 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
