Actos is a drug owned by Takeda Pharmaceuticals Usa Inc. It is protected by 10 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 09, 2016. Details of Actos'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). | |||
| US6303640 | Pharmaceutical composition |
Aug, 2016
(8 years ago) |
Expired
|
| US6150383 | 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
|
| US6271243 | Pharmaceutical composition |
Jun, 2016
(8 years ago) |
Expired
|
| US6329404 | Pharmaceutical composition |
Jun, 2016
(8 years ago) |
Expired
|
| US6172090 | Pharmaceutical composition |
Jun, 2016
(8 years ago) |
Expired
|
| US6211205 | Pharmaceutical composition |
Jun, 2016
(8 years ago) |
Expired
|
| US6166043 | Pharmaceutical composition |
Jun, 2016
(8 years ago) |
Expired
|
| US6150384 | Pharmaceutical composition |
Jun, 2016
(8 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Actos 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 Actos's family patents as well as insights into ongoing legal events on those patents.
Actos's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Actos's generic launch date based on the expiry of its last outstanding patent is estimated to be Aug 09, 2016 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Actos Generic API suppliers:
Pioglitazone Hydrochloride is the generic name for the brand Actos. 14 different companies have already filed for the generic of Actos, with Chartwell Rx having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Actos's generic
How can I launch a generic of Actos before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Actos's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Actos'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 Actos -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 15 mg, 30 mg and 45 mg |
Alternative Brands for Actos
Actos which is used for managing and improving glycemic control in patients with type 2 diabetes. ., has several other brand drugs in the same treatment category and using the same active ingredient (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 | Treatment Area | ||
|---|---|---|---|---|
| Takeda Pharms Usa |
| |||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Pioglitazone Hydrochloride. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |||
|---|---|---|---|---|
| Takeda Pharms Usa |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Pioglitazone Hydrochloride, Actos's active ingredient. Check the complete list of approved generic manufacturers for Actos
About Actos
Actos is a drug owned by Takeda Pharmaceuticals Usa Inc. It is used for managing and improving glycemic control in patients with type 2 diabetes. . Actos uses Pioglitazone Hydrochloride as an active ingredient. Actos was launched by Takeda Pharms Usa in 1999.
Approval Date:
Actos was approved by FDA for market use on 15 July, 1999.
Active Ingredient:
Actos uses Pioglitazone Hydrochloride as the active ingredient. Check out other Drugs and Companies using Pioglitazone Hydrochloride ingredient
Treatment:
Actos is used for managing and improving glycemic control in patients with type 2 diabetes. .
Dosage:
Actos is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 45MG BASE | TABLET | Prescription | ORAL |
| EQ 15MG BASE | TABLET | Prescription | ORAL |
| EQ 30MG BASE | TABLET | Prescription | ORAL |