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. Five 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
There have been two 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
International Patents: | 41 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Clinical Trials: | 3 |
Patent Applications: | 54 |
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Tablet
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
Takeda Pharms Usa | ACTOPLUS MET XR | metformin hydrochloride; pioglitazone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022024-001 | May 12, 2009 | DISCN | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Takeda Pharms Usa | ACTOPLUS MET | metformin hydrochloride; pioglitazone hydrochloride | TABLET;ORAL | 021842-002 | Aug 29, 2005 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
>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 | See Plans and Pricing | See Plans and Pricing |
Takeda Pharms Usa | ACTOPLUS MET | metformin hydrochloride; pioglitazone hydrochloride | TABLET;ORAL | 021842-002 | Aug 29, 2005 | See Plans and Pricing | See Plans and Pricing |
Takeda Pharms Usa | ACTOPLUS MET | metformin hydrochloride; pioglitazone hydrochloride | TABLET;ORAL | 021842-001 | Aug 29, 2005 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ACTOPLUS MET
When does loss-of-exclusivity occur for ACTOPLUS MET?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 03271103
Estimated Expiration: See Plans and Pricing
Brazil
Patent: 15082
Estimated Expiration: See Plans and Pricing
Canada
Patent: 01587
Estimated Expiration: See Plans and Pricing
China
Patent: 17253
Estimated Expiration: See Plans and Pricing
Patent: 0427143
Estimated Expiration: See Plans and Pricing
Colombia
Patent: 00740
Estimated Expiration: See Plans and Pricing
Costa Rica
Patent: 97
Estimated Expiration: See Plans and Pricing
Cyprus
Patent: 14863
Estimated Expiration: See Plans and Pricing
Denmark
Patent: 61472
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 61472
Estimated Expiration: See Plans and Pricing
Hong Kong
Patent: 80385
Estimated Expiration: See Plans and Pricing
Israel
Patent: 7835
Estimated Expiration: See Plans and Pricing
Japan
Patent: 36553
Estimated Expiration: See Plans and Pricing
Patent: 04149521
Estimated Expiration: See Plans and Pricing
Patent: 08208141
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 05003668
Estimated Expiration: See Plans and Pricing
Morocco
Patent: 487
Estimated Expiration: See Plans and Pricing
New Zealand
Patent: 9711
Estimated Expiration: See Plans and Pricing
Patent: 2559
Estimated Expiration: See Plans and Pricing
Norway
Patent: 2993
Estimated Expiration: See Plans and Pricing
Patent: 052239
Estimated Expiration: See Plans and Pricing
Poland
Patent: 9608
Estimated Expiration: See Plans and Pricing
Patent: 6176
Estimated Expiration: See Plans and Pricing
Portugal
Patent: 61472
Estimated Expiration: See Plans and Pricing
Russian Federation
Patent: 57757
Estimated Expiration: See Plans and Pricing
Patent: 05113999
Estimated Expiration: See Plans and Pricing
Slovenia
Patent: 61472
Estimated Expiration: See Plans and Pricing
South Africa
Patent: 0503507
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 0820609
Estimated Expiration: See Plans and Pricing
Patent: 050070039
Estimated Expiration: See Plans and Pricing
Patent: 070119095
Estimated Expiration: See Plans and Pricing
Spain
Patent: 37072
Estimated Expiration: See Plans and Pricing
Ukraine
Patent: 991
Estimated Expiration: See Plans and Pricing
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 around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Austria | 41931 | See Plans and Pricing | |
Japan | 4809806 | See Plans and Pricing | |
Taiwan | 438587 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ACTOPLUS MET
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0861666 | 300258 | Netherlands | See Plans and Pricing | 300258, 20160620, EXPIRES: 20210619 |
1506211 | 179 5017-2014 | Slovakia | See Plans and Pricing | PRODUCT NAME: KOMBINACIA DAPAGLIFLOZINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI A METFORMINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI; REGISTRATION NO/DATE: EU/1/13/900/001 - EU/1/13/900/012 20140116 |
1506211 | PA2014026,C1506211 | Lithuania | See Plans and Pricing | PRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |