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 seven 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: | 48 |
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 | 022024-001 | 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 | 021842-001 | 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 |
---|---|---|---|
European Patent Office | 2292268 | ⤷ Try a Trial | |
Argentina | 005641 | COMPOSICION FARMACEUTICA PARA DISMINUIR LA HIPERGLICEMIA Y PARA PROFILAXIS Y TRATAMIENTO DE DIABETES | ⤷ Try a Trial |
Mexico | 9202933 | DERIVADOS DE TIAZOLIDINDIONA. | ⤷ 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 |
---|---|---|---|---|
1506211 | 300677 | 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 | C300524 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE VAN SAXAGLIPTINE EN METFORMINE, DESGEWENST IN DE VORM VAN FARMACEUTISCH AANVAARDBARE AFGELEIDEN DAARVAN; NAT. REGISTRATION NO/DATE: EU/1/11/731/001-012 20111124; FIRST REGISTRATION: |
0193256 | C300038 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: PIOGLITAZON, DESGEWENST IN DE VORM VAN EEN FARMACOLOGISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/00/151/001 - EU/1/00/151/006 20001011 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |