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
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Questions you can ask:
- What is the 5 year forecast for ACTOPLUS MET XR?
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- What is Average Wholesale Price for ACTOPLUS MET XR?
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: | 58 |
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 |
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.
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 | 022024-001 | May 12, 2009 | ⤷ Try for Free | ⤷ Try for Free |
Takeda Pharms Usa | ACTOPLUS MET XR | metformin hydrochloride; pioglitazone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022024-001 | May 12, 2009 | ⤷ Try for Free | ⤷ Try for Free |
Takeda Pharms Usa | ACTOPLUS MET XR | metformin hydrochloride; pioglitazone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022024-002 | May 12, 2009 | ⤷ Try for Free | ⤷ Try for Free |
Takeda Pharms Usa | ACTOPLUS MET XR | metformin hydrochloride; pioglitazone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022024-001 | May 12, 2009 | ⤷ Try for Free | ⤷ Try for Free |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ACTOPLUS MET XR
When does loss-of-exclusivity occur for ACTOPLUS MET XR?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 4238
Patent: COMPOSICION FARMACEUTICA QUE CONTIENE UNA BIGUANIDA Y UN DERIVADO DE TIAZOLIDINDIONA
Estimated Expiration: ⤷ Try for Free
Canada
Patent: 01501
Patent: NOUVELLE FORMULATION PHARMACEUTIQUE CONTENANT UN BIGUANIDE ET UN DERIVE DE THIAZOLIDINEDIONE (NOVEL PHARMACEUTICAL FORMULATION CONTAINING A BIGUANIDE AND A THIAZOLIDINEDIONE DERIVATIVE)
Estimated Expiration: ⤷ Try for Free
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering ACTOPLUS MET XR around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Spain | 2541124 | ⤷ Try for Free | |
South Korea | 20050053677 | MULTISTAGE FORMULATION CONTAINING A BIGUANIDE AND THIAZOLIDINDIONE DERIVATIVES | ⤷ Try for Free |
New Zealand | 525559 | Controlled release metformin compositions for the reduction of serum glucose levels in human patients with NIDDM | ⤷ Try for Free |
Germany | 69631157 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ACTOPLUS MET XR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0193256 | SPC/GB01/016 | United Kingdom | ⤷ Try for Free | PRODUCT NAME: PIOGLITAZONE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE HYDROCHLORIDE SALT; REGISTERED: CH IKS 55 378 01 20000927; CH IKS 55 378 02 20000927; CH IKS 55 378 03 20000927; UK EU/1/00/151/001 20001011; UK EU/1/00/151/002 20001011; UK EU/1/00/151/003 20001011; UK EU/1/00/151/004 20001011; UK EU/1/00/151/005 20001011; UK EU/1/00/151/006 20001011 |
2498758 | 301040 | Netherlands | ⤷ Try for Free | PRODUCT NAME: METFORMINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; SAXAGLIPTINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/19/1401 20191113 |
0861666 | 07C0006 | France | ⤷ Try for Free | PRODUCT NAME: PIOGLITAZONE/METFORMINE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/06/354/001 DU 20060728; REGISTRATION NO/DATE AT EEC: EU/1/06/354/001 DU 20060728 |
0861666 | C00861666/01 | Switzerland | ⤷ Try for Free | FORMER REPRESENTATIVE: BOHEST AG, CH |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for ACTOPLUS MET XR
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