DrugPatentWatch Database Preview
ACTOPLUS MET XR Drug Profile
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 seven patents protecting this drug and one Paragraph IV challenge.
This drug has eighty-six patent family members in twenty-four 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.
Summary for ACTOPLUS MET XR
| International Patents: | 86 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 3 |
| 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 |
Recent Litigation for ACTOPLUS MET XR
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Shionogi Inc. v. Amneal Pharmaceuticals, LLC | 2018-10-11 |
| SHIONOGI INC. v. ZYDUS PHARMACEUTICALS (USA) INC. | 2018-08-16 |
| Shionogi Inc. v. Qingdao Baheal Pharmaceutical Co. Ltd. | 2017-09-22 |
See all ACTOPLUS MET XR litigation
PTAB Litigation
| Petitioner | Date |
|---|---|
| Aurobindo Pharma USA Inc. | 2018-01-24 |
| Aurobindo Pharma USA Inc. | 2017-06-23 |
| Aurobindo Pharma USA Inc. | 2017-06-22 |
Pharmacology for ACTOPLUS MET XR
Synonyms for ACTOPLUS MET XR
| 737811-27-7 |
| ACTOPLUS MET |
| 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 XR
Expired US Patents for ACTOPLUS MET XR
Paragraph IV (Patent) Challenges for ACTOPLUS MET XR
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Extended-release Tablets | 15 mg/1000 mg and 30 mg/1000 mg | ➤ Subscribe | See Pricing |
International Patents for ACTOPLUS MET XR
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2013209426 | See Pricing |
| Singapore | 160415 | See Pricing |
| Australia | 3083002 | See Pricing |
| Argentina | 054238 | See Pricing |
| China | 101675929 | See Pricing |
| Eurasian Patent Organization | 015244 | See Pricing |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ACTOPLUS MET XR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1506211 | CR 2014 00037 | Denmark | See Pricing | 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 |
| 1412357 | PA2008013 | Lithuania | See Pricing | PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REG. NO/DATE: EU/1/08/455/001-014 20080716 |
| 1506211 | PA2014026 | Lithuania | See Pricing | PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116 |
| 1506211 | CA 2014 00037 | Denmark | See Pricing | 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 |
| 1506211 | 122014000071 | Germany | See Pricing | PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116 |
| 1261586 | 1290013-0 | Sweden | See Pricing | PRODUCT NAME: SAXAGLIPTIN/METFORMIN; REG. NO/DATE: EU/1/11/731/001 20111124 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
