Actoplus Met Xr is a drug owned by Takeda Pharmaceuticals Usa Inc. It is protected by 15 US drug patents filed from 2013 to 2015. Out of these, 2 drug patents are active and 13 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 31, 2026. Details of Actoplus Met Xr'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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7959946 | Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative |
Jul, 2026
(1 year, 7 months from now) | Active |
| US7785627 | Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative |
Jul, 2026
(1 year, 7 months from now) | Active |
| US8470368 | Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative |
Sep, 2023
(1 year, 3 months ago) |
Expired
|
| US8668931 | Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative |
Sep, 2023
(1 year, 3 months ago) |
Expired
|
| US9060941 | Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative |
Sep, 2023
(1 year, 3 months ago) |
Expired
|
| US6866866 | Controlled release metformin compositions |
Mar, 2021
(3 years ago) |
Expired
|
| US6790459 | Methods for treating diabetes via administration of controlled release metformin |
Mar, 2021
(3 years ago) |
Expired
|
| US6099859 | Controlled release oral tablet having a unitary core |
Mar, 2018
(6 years ago) |
Expired
|
| US8475841 | Controlled release metformin formulations |
Mar, 2018
(6 years ago) |
Expired
|
| US7919116 | Controlled release metformin formulations |
Mar, 2018
(6 years ago) |
Expired
|
| US6495162 | Controlled release oral tablet having a unitary core |
Mar, 2018
(6 years ago) |
Expired
|
| US6172090 | Pharmaceutical composition |
Jun, 2016
(8 years ago) |
Expired
|
| US6166043 | Pharmaceutical composition |
Jun, 2016
(8 years ago) |
Expired
|
| US5965584 | Pharmaceutical composition |
Jun, 2016
(8 years ago) |
Expired
|
| US6166042 | Pharmaceutical composition |
Jun, 2016
(8 years ago) |
Expired
|
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 Xr's patents.
Latest Legal Activities on Actoplus Met Xr's Patents
Given below is the list of recent legal activities going on the following patents of Actoplus Met Xr.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 08 May, 2023 | US7919116 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 14 Dec, 2022 | US9060941 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 07 Dec, 2022 | US7959946 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 21 Nov, 2022 | US7919116 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 23 Feb, 2022 | US7785627 (Litigated) |
| Expire Patent Critical | 09 Aug, 2021 | US8475841 |
| Maintenance Fee Reminder Mailed Critical | 22 Feb, 2021 | US8475841 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 14 Dec, 2020 | US8470368 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 10 Dec, 2018 | US9060941 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 04 Dec, 2018 | US7959946 (Litigated) |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Actoplus Met Xr and ongoing litigations to help you estimate the early arrival of Actoplus Met Xr generic.
Actoplus Met Xr's Litigations
Actoplus Met Xr been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jun 23, 2017, against patent number US6790459. The petitioner Aurobindo Pharma USA Inc., challenged the validity of this patent, with Andrx Labs, LLC as the respondent. Click below to track the latest information on how companies are challenging Actoplus Met Xr's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US6866866 | June, 2017 |
FWD Entered
(28 Dec, 2018) | Andrx Labs, LLC | Aurobindo Pharma USA Inc. |
| US6790459 | January, 2018 |
Terminated-Denied
(05 Sep, 2018) | Andrx Labs, LLC | Aurobindo Pharma USA Inc. |
| US6790459 | June, 2017 |
Terminated-Denied
(29 Dec, 2017) | Andrx Labs, LLC | Aurobindo Pharma USA Inc. |
US patents provide insights into the exclusivity only within the United States, but Actoplus Met Xr 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 Xr's family patents as well as insights into ongoing legal events on those patents.
Actoplus Met Xr's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Actoplus Met Xr's generic launch date based on the expiry of its last outstanding patent is estimated to be Jul 31, 2026 (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 Xr Generic API suppliers:
Metformin Hydrochloride; Pioglitazone Hydrochloride is the generic name for the brand Actoplus Met Xr. 6 different companies have already filed for the generic of Actoplus Met Xr, 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 Xr's generic
How can I launch a generic of Actoplus Met Xr before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Actoplus Met Xr's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Actoplus Met Xr's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Actoplus Met Xr -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 15 mg/1000 mg and 30 mg/1000 mg | 23 Sep, 2011 | 1 | 31 Jul, 2026 | Extinguished |
Alternative Brands for Actoplus Met Xr
Actoplus Met Xr which is used for improving glycemic control in patients with type 2 diabetes mellitus., has several other brand drugs using the same active ingredient (Metformin Hydrochloride; Pioglitazone Hydrochloride). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Takeda Pharms Usa |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Metformin Hydrochloride; Pioglitazone Hydrochloride, Actoplus Met Xr's active ingredient. Check the complete list of approved generic manufacturers for Actoplus Met Xr
About Actoplus Met Xr
Actoplus Met Xr is a drug owned by Takeda Pharmaceuticals Usa Inc. It is used for improving glycemic control in patients with type 2 diabetes mellitus. Actoplus Met Xr uses Metformin Hydrochloride; Pioglitazone Hydrochloride as an active ingredient. Actoplus Met Xr was launched by Takeda Pharms Usa in 2009.
Approval Date:
Actoplus Met Xr was approved by FDA for market use on 12 May, 2009.
Active Ingredient:
Actoplus Met Xr uses Metformin Hydrochloride; Pioglitazone Hydrochloride as the active ingredient. Check out other Drugs and Companies using Metformin Hydrochloride; Pioglitazone Hydrochloride ingredient
Treatment:
Actoplus Met Xr is used for improving glycemic control in patients with type 2 diabetes mellitus.
Dosage:
Actoplus Met Xr is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE | Discontinued | ORAL |