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ACTOPLUS MET XR Drug 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 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.
US ANDA Litigation and Generic Entry Outlook for Actoplus Met Xr
Actoplus Met Xr was eligible for patent challenges on December 31, 1968.
There have been fifteen 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: | 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 |
Paragraph IV (Patent) Challenges for ACTOPLUS MET XR
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ACTOPLUS MET XR | TABLET, EXTENDED RELEASE;ORAL | metformin hydrochloride; pioglitazone hydrochloride | 022024 | 2011-09-23 |
US Patents and Regulatory Information for ACTOPLUS MET XR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Takeda Pharms Usa | ACTOPLUS MET XR | metformin hydrochloride; pioglitazone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022024-001 | May 12, 2009 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Takeda Pharms Usa | ACTOPLUS MET XR | metformin hydrochloride; pioglitazone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022024-001 | May 12, 2009 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Takeda Pharms Usa | ACTOPLUS MET XR | metformin hydrochloride; pioglitazone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022024-001 | May 12, 2009 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Takeda Pharms Usa | ACTOPLUS MET XR | metformin hydrochloride; pioglitazone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022024-002 | May 12, 2009 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Takeda Pharms Usa | ACTOPLUS MET XR | metformin hydrochloride; pioglitazone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022024-002 | May 12, 2009 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for ACTOPLUS MET XR
International Patents for ACTOPLUS MET XR
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2008100240 | Start Trial |
| Eurasian Patent Organization | 015244 | Start Trial |
| European Patent Office | 1863445 | Start Trial |
| European Patent Office | 1539144 | Start Trial |
| European Patent Office | 1663170 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ACTOPLUS MET XR
| 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 |
| 1261586 | 1290013-0 | Sweden | Start Trial | PRODUCT NAME: SAXAGLIPTIN/METFORMIN; REG. NO/DATE: EU/1/11/731/001 20111124 |
| 1412357 | PA2008013,C1412357 | Lithuania | Start Trial | PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716 |
| 1506211 | 42/2014 | Austria | Start 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 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
