ACTOPLUS MET Drug Patent Profile
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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 four patents protecting this drug.
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.
DrugPatentWatch® Generic Entry Outlook for Actoplus Met
Indicators of Generic Entry
Summary for ACTOPLUS MET
International Patents: | 41 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 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 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ACTOPLUS MET |
What excipients (inactive ingredients) are in ACTOPLUS MET? | ACTOPLUS MET excipients list |
DailyMed Link: | ACTOPLUS MET at DailyMed |
US Patents and Regulatory Information for ACTOPLUS MET
ACTOPLUS MET is protected by two US patents.
Patents protecting ACTOPLUS MET
Solid preparation
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Tablet
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | metformin hydrochloride; pioglitazone hydrochloride | TABLET;ORAL | 021842-001 | Aug 29, 2005 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Takeda Pharms Usa | ACTOPLUS MET XR | metformin hydrochloride; pioglitazone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022024-002 | May 12, 2009 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Takeda Pharms Usa | ACTOPLUS MET | metformin hydrochloride; pioglitazone hydrochloride | TABLET;ORAL | 021842-002 | Aug 29, 2005 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Takeda Pharms Usa | ACTOPLUS MET | metformin hydrochloride; pioglitazone hydrochloride | TABLET;ORAL | 021842-002 | Aug 29, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
Takeda Pharms Usa | ACTOPLUS MET | metformin hydrochloride; pioglitazone hydrochloride | TABLET;ORAL | 021842-001 | Aug 29, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
Takeda Pharms Usa | ACTOPLUS MET | metformin hydrochloride; pioglitazone hydrochloride | TABLET;ORAL | 021842-002 | Aug 29, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ACTOPLUS MET
See the table below for patents covering ACTOPLUS MET around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 723097 | ⤷ Try a Trial | |
Japan | 4809806 | ⤷ Try a Trial | |
Norway | 20052239 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ACTOPLUS MET
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1412357 | C 2008 016 | Romania | ⤷ Try a 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 |
2498758 | LUC00152 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: METFORMINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; SAXAGLIPTINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; DAPAGLIFLOZINE OU UN SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1401 20191113 |
1412357 | DO 77; 5006-2008 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |