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Last Updated: May 19, 2022

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 five 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. 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 Xr

There have been seven 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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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 five US patents.

Patents protecting ACTOPLUS MET XR

Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
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 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 XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-002 May 12, 2009 DISCN 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 XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-002 May 12, 2009 DISCN Yes No 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 XR

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
Estimated Expiration: See Plans and Pricing

Australia

Patent: 03272504
Estimated Expiration: See Plans and Pricing

Patent: 04283059
Estimated Expiration: See Plans and Pricing

Patent: 06232993
Estimated Expiration: See Plans and Pricing

Patent: 11202162
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0414471
Estimated Expiration: See Plans and Pricing

Patent: 0609550
Estimated Expiration: See Plans and Pricing

Canada

Patent: 99597
Estimated Expiration: See Plans and Pricing

Patent: 37665
Estimated Expiration: See Plans and Pricing

Patent: 01501
Estimated Expiration: See Plans and Pricing

China

Patent: 81496
Estimated Expiration: See Plans and Pricing

Patent: 52703
Estimated Expiration: See Plans and Pricing

Patent: 0544717
Estimated Expiration: See Plans and Pricing

Patent: 1222912
Estimated Expiration: See Plans and Pricing

Patent: 1623274
Estimated Expiration: See Plans and Pricing

Patent: 1675929
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 55
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 5244
Estimated Expiration: See Plans and Pricing

Patent: 0702116
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 39144
Estimated Expiration: See Plans and Pricing

Patent: 63170
Estimated Expiration: See Plans and Pricing

Patent: 63445
Estimated Expiration: See Plans and Pricing

Patent: 04266
Estimated Expiration: See Plans and Pricing

Georgia, Republic of

Patent: 0104936
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 78783
Estimated Expiration: See Plans and Pricing

Patent: 14337
Estimated Expiration: See Plans and Pricing

Patent: 36780
Estimated Expiration: See Plans and Pricing

Israel

Patent: 6308
Estimated Expiration: See Plans and Pricing

Japan

Patent: 94841
Estimated Expiration: See Plans and Pricing

Patent: 18465
Estimated Expiration: See Plans and Pricing

Patent: 27781
Estimated Expiration: See Plans and Pricing

Patent: 81962
Estimated Expiration: See Plans and Pricing

Patent: 54909
Estimated Expiration: See Plans and Pricing

Patent: 06502187
Estimated Expiration: See Plans and Pricing

Patent: 07505903
Estimated Expiration: See Plans and Pricing

Patent: 08534589
Estimated Expiration: See Plans and Pricing

Patent: 11148819
Estimated Expiration: See Plans and Pricing

Patent: 13209426
Estimated Expiration: See Plans and Pricing

Patent: 14196314
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 6095
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 07011824
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 675
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 5653
Estimated Expiration: See Plans and Pricing

Patent: 1124
Estimated Expiration: See Plans and Pricing

Patent: 0804
Estimated Expiration: See Plans and Pricing

Norway

Patent: 075427
Estimated Expiration: See Plans and Pricing

Peru

Patent: 061389
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 0415
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0707137
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1249171
Estimated Expiration: See Plans and Pricing

Patent: 1363679
Estimated Expiration: See Plans and Pricing

Patent: 1401412
Estimated Expiration: See Plans and Pricing

Patent: 050053677
Estimated Expiration: See Plans and Pricing

Patent: 060076299
Estimated Expiration: See Plans and Pricing

Patent: 080005359
Estimated Expiration: See Plans and Pricing

Patent: 100137023
Estimated Expiration: See Plans and Pricing

Patent: 110126761
Estimated Expiration: See Plans and Pricing

Patent: 120034211
Estimated Expiration: See Plans and Pricing

Patent: 130039344
Estimated Expiration: See Plans and Pricing

Spain

Patent: 29180
Estimated Expiration: See Plans and Pricing

Patent: 41124
Estimated Expiration: See Plans and Pricing

Patent: 73321
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 44375
Estimated Expiration: See Plans and Pricing

Patent: 61070
Estimated Expiration: See Plans and Pricing

Patent: 0529831
Estimated Expiration: See Plans and Pricing

Patent: 0718433
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 852
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 XR around the world.

Country Patent Number Title Estimated Expiration
Canada 2179584 COMPOSITION PHARMACEUTIQUE CONTENANT UN ACTIVATEUR DE LA SENSIBILITE A L'INSULINE EN COMBINAISON AVEC UN AUTRE ANTIDIABETIQUE (PHARMACEUTICAL COMPOSITION CONTAINING INSULIN SENSITIVITY ENHANCER IN COMBINATION WITH ANOTHER ANTIDIABETIC) See Plans and Pricing
Japan 3148973 See Plans and Pricing
Georgia, Republic of P20104936 NOVEL PHARMACEUTICAL FORMULATION CONTAINING A BIGUANIDE AND A THIAZOLIDINEDIONE DERIVATIVE See Plans and Pricing
China 101623274 Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ACTOPLUS MET XR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1261586 132012902044560 Italy See Plans and Pricing PRODUCT NAME: SAXAGLIPTIN E METFORMINA(KOMBOGLYZE); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/11/731/001 A EU/1/11/731/014, 20111124
1412357 CA 2008 00035 Denmark See Plans and Pricing PRODUCT NAME: SITAGLIPTIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER MONOPHOSPHAT, METFORMIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER HYDROCHLORID
1506211 SPC/GB14/050 United Kingdom See Plans and Pricing PRODUCT NAME: A COMBINATION OF DAPAGLIFLOZIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND METFORMIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/900 20140121
0193256 SPC/GB01/016 United Kingdom See Plans and Pricing 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
>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.