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Last Updated: June 27, 2022

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

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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

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.