Actoplus Met Patent Expiration

Actoplus Met is a drug owned by Takeda Pharmaceuticals Usa Inc. It is protected by 6 US drug patents filed from 2013 to 2016. Out of these, 2 drug patents are active and 4 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 03, 2029. Details of Actoplus Met's patents and their expiration are given in the table below.


Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5965584 Pharmaceutical composition
Jun, 2016

(8 years ago)

Expired
US6166042 Pharmaceutical composition
Jun, 2016

(8 years ago)

Expired
US6166043 Pharmaceutical composition
Jun, 2016

(8 years ago)

Expired
US6172090 Pharmaceutical composition
Jun, 2016

(8 years ago)

Expired
US9101660 Solid preparation
Jan, 2027

(2 years from now)

Active
US9320714 Tablet
Feb, 2029

(4 years from now)

Active


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Actoplus Met's patents.

Given below is the list of recent legal activities going on the following patents of Actoplus Met.

Event Date Patent/Publication
Patent litigations
Payment of Maintenance Fee, 8th Year, Large Entity 21 Jan, 2023 US9101660
Payment of Maintenance Fee, 4th Year, Large Entity 31 Jan, 2019 US9101660
Post Issue Communication - Certificate of Correction 29 Jan, 2016 US9101660
Patent Issue Date Used in PTA Calculation 11 Aug, 2015 US9101660
Recordation of Patent Grant Mailed 11 Aug, 2015 US9101660
Email Notification 23 Jul, 2015 US9101660
Issue Notification Mailed 22 Jul, 2015 US9101660
Dispatch to FDC 07 Jul, 2015 US9101660
Application Is Considered Ready for Issue 06 Jul, 2015 US9101660
Issue Fee Payment Verified 01 Jul, 2015 US9101660


FDA has granted several exclusivities to Actoplus Met. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Actoplus Met, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Actoplus Met.

Exclusivity Information

Actoplus Met holds 1 exclusivities. All of its exclusivities have expired in 2015. Details of Actoplus Met's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
M(M-116) May 17, 2015

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Several oppositions have been filed on Actoplus Met's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Actoplus Met's generic, the next section provides detailed information on ongoing and past EP oppositions related to Actoplus Met patents.

Actoplus Met's oppositions filed in EPO

Actoplus Met has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jul 02, 2014, by Dr Klusmann Peter. This opposition was filed on patent number EP03751344A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP03751344A Jul, 2014 Generics [UK] Limited Patent maintained as amended
EP03751344A Jul, 2014 Dr Klusmann Peter Patent maintained as amended


US patents provide insights into the exclusivity only within the United States, but Actoplus Met is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Actoplus Met's family patents as well as insights into ongoing legal events on those patents.

Actoplus Met's family patents

Actoplus Met has patent protection in a total of 25 countries. It's US patent count contributes only to 10.0% of its total global patent coverage. 3 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Actoplus Met.

Family Patents

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Generic Launch

Generic Release Date:

Actoplus Met's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 03, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Actoplus Met Generics:

Metformin Hydrochloride; Pioglitazone Hydrochloride is the generic name for the brand Actoplus Met. 6 different companies have already filed for the generic of Actoplus Met, with Aurobindo Pharma Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Actoplus Met's generic





About Actoplus Met

Actoplus Met is a drug owned by Takeda Pharmaceuticals Usa Inc. It is used for improving glycemic control in patients with type 2 diabetes already on a combination of pioglitazone and metformin or a thiazolidinedione (TZD) and metformin. Actoplus Met uses Metformin Hydrochloride; Pioglitazone Hydrochloride as an active ingredient. Actoplus Met was launched by Takeda Pharms Usa in 2005.

Market Authorisation Date:

Actoplus Met was approved by FDA for market use on 29 August, 2005.

Active Ingredient:

Actoplus Met uses Metformin Hydrochloride; Pioglitazone Hydrochloride as the active ingredient. Check out other Drugs and Companies using Metformin Hydrochloride; Pioglitazone Hydrochloride ingredient

Treatment:

Actoplus Met is used for improving glycemic control in patients with type 2 diabetes already on a combination of pioglitazone and metformin or a thiazolidinedione (TZD) and metformin.

Dosage:

Actoplus Met is available in tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
500MG;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET Discontinued ORAL
850MG;EQ 15MG BASE TABLET Prescription ORAL