ACTOPLUS MET XR Drug Patent 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 two patents protecting this drug and one Paragraph IV challenge.
This drug has seventy-two patent family members in twenty-five 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.
DrugPatentWatch® Generic Entry Outlook for Actoplus Met Xr
There have been four 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: | 72 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 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 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 |
Anatomical Therapeutic Chemical (ATC) Classes for ACTOPLUS MET XR
Paragraph IV (Patent) Challenges for ACTOPLUS MET XR
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ACTOPLUS MET XR | Extended-release Tablets | metformin hydrochloride; pioglitazone hydrochloride | 15 mg/1000 mg and 30 mg/1000 mg | 022024 | 1 | 2011-09-23 |
US Patents and Regulatory Information for ACTOPLUS MET XR
ACTOPLUS MET XR is protected by two US patents.
Patents protecting ACTOPLUS MET XR
Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
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 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 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 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 | |||
>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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Takeda Pharms Usa | ACTOPLUS MET XR | metformin hydrochloride; pioglitazone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022024-002 | May 12, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Takeda Pharms Usa | ACTOPLUS MET XR | metformin hydrochloride; pioglitazone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022024-001 | May 12, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Takeda Pharms Usa | ACTOPLUS MET XR | metformin hydrochloride; pioglitazone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022024-001 | May 12, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ACTOPLUS MET XR
See the table below for patents covering ACTOPLUS MET XR around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Czech Republic | 291624 | Farmaceutický přípravek (Pharmaceutical composition) | ⤷ Try a Trial |
Japan | 5881962 | ⤷ Try a Trial | |
Austria | 438397 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ACTOPLUS MET XR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2498758 | PA2020003,C2498758 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: METFORMINO HIDROCHLORIDAS; SAKSAGLIPTINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; DAPAGLIFLOZINAS ARBA FARMACINIU POZIURIU PRIIMTINAS JO SOLVATAS; REGISTRATION NO/DATE: EU/1/19/1401 20191111 |
1506211 | 42/2014 | Austria | ⤷ Try a 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 | C300677 | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |