Mirapex Er is a drug owned by Boehringer Ingelheim Pharmaceuticals Inc. It is protected by 2 US drug patents filed from 2013 to 2014 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 08, 2029. Details of Mirapex Er'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). | |||
| US8679533 | Pramipexole once-daily dosage form |
Sep, 2029
(4 years from now) | Active |
| US7695734 | Extended release tablet formulation containing pramipexole or a pharmaceutically acceptable salt thereof |
Apr, 2028
(3 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 Mirapex Er's patents.
Latest Legal Activities on Mirapex Er's Patents
Given below is the list of recent legal activities going on the following patents of Mirapex Er.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 06 Oct, 2021 | US7695734 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 12 Aug, 2021 | US8679533 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 03 Oct, 2017 | US7695734 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 29 Aug, 2017 | US8679533 |
| Mail O.P. Petition Decision | 22 Apr, 2015 | US8679533 |
| Mail-Petition Decision - Dismissed Critical | 21 Apr, 2015 | US8679533 |
| Petition Decision - Dismissed Critical | 20 Apr, 2015 | US8679533 |
| O.P. Petition Decision | 19 Apr, 2015 | US8679533 |
| Adjustment of PTA Calculation by PTO | 19 Apr, 2015 | US8679533 |
| Petition Entered | 20 May, 2014 | US8679533 |
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 Mirapex Er and ongoing litigations to help you estimate the early arrival of Mirapex Er generic.
Mirapex Er's Litigations
Mirapex Er been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Sep 26, 2011, against patent number US8679533. The petitioner , challenged the validity of this patent, with Ernest J. Lee et al as the respondent. Click below to track the latest information on how companies are challenging Mirapex Er's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8679533 | September, 2011 |
Decision
(22 Oct, 2013) | Ernest J. Lee et al | |
FDA has granted some exclusivities to Mirapex Er. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Mirapex Er, 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 Mirapex Er.
Exclusivity Information
Mirapex Er holds 2 exclusivities. All of its exclusivities have expired in 2013. Details of Mirapex Er's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | Feb 19, 2013 |
| New Indication(I-623) | Mar 19, 2013 |
Several oppositions have been filed on Mirapex Er'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 Mirapex Er's generic, the next section provides detailed information on ongoing and past EP oppositions related to Mirapex Er patents.
Mirapex Er's Oppositions Filed in EPO
Mirapex Er has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Aug 03, 2011, by Sölch, Günter. This opposition was filed on patent number EP05777774A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP03771959A | Jun, 2014 | Maiwald Patentanwalts GmbH | Opposition rejected |
| EP03771959A | Oct, 2013 | Actavis Group PTC ehf | Opposition rejected |
| EP05763065A | Aug, 2012 | Dr. May, Mark Andrew | Patent maintained as amended |
| EP05777774A | Aug, 2011 | Teva Pharmaceutical Industries LTD. | Patent maintained as amended |
| EP05777774A | Aug, 2011 | Sölch, Günter | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Mirapex Er 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 Mirapex Er's family patents as well as insights into ongoing legal events on those patents.
Mirapex Er's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Mirapex Er's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 08, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Mirapex Er Generic API suppliers:
Pramipexole Dihydrochloride is the generic name for the brand Mirapex Er. 24 different companies have already filed for the generic of Mirapex Er, with Heritage Pharma Avet having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Mirapex Er's generic
How can I launch a generic of Mirapex Er before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Mirapex Er's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Mirapex Er'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 Mirapex Er -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.375 mg, 0.75 mg, 1.5 mg, 3 mg and 4.5 mg | 01 Jun, 2010 | 1 | 26 Apr, 2028 | Extinguished | |
| 2.25 mg and 3.75 mg | 26 Jul, 2011 | 1 | 06 Feb, 2014 | 26 Apr, 2028 | Eligible |
Alternative Brands for Mirapex Er
Mirapex Er which is used for managing symptoms of Parkinson's disease., has several other brand drugs in the same treatment category and using the same active ingredient (Pramipexole Dihydrochloride). 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 | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bausch |
| |||||||||||||||
| Impax |
| |||||||||||||||
| Orion Pharma |
| |||||||||||||||
| Supernus Pharms |
| |||||||||||||||
| Teva |
| |||||||||||||||
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. Pramipexole Dihydrochloride. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Boehringer Ingelheim |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Pramipexole Dihydrochloride, Mirapex Er's active ingredient. Check the complete list of approved generic manufacturers for Mirapex Er
About Mirapex Er
Mirapex Er is a drug owned by Boehringer Ingelheim Pharmaceuticals Inc. It is used for managing symptoms of Parkinson's disease. Mirapex Er uses Pramipexole Dihydrochloride as an active ingredient. Mirapex Er was launched by Boehringer Ingelheim in 2010.
Approval Date:
Mirapex Er was approved by FDA for market use on 19 February, 2010.
Active Ingredient:
Mirapex Er uses Pramipexole Dihydrochloride as the active ingredient. Check out other Drugs and Companies using Pramipexole Dihydrochloride ingredient
Treatment:
Mirapex Er is used for managing symptoms of Parkinson's disease.
Dosage:
Mirapex Er is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 3MG | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| 0.75MG | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| 3.75MG | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| 0.375MG | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| 4.5MG | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| 1.5MG | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| 2.25MG | TABLET, EXTENDED RELEASE | Discontinued | ORAL |