Mirapex is a drug owned by Boehringer Ingelheim. It is protected by 2 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 Jan 16, 2018. Details of Mirapex'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). | |||
| US6001861 | Use of pramipexole in the treatment of restless legs syndrome |
Jan, 2018
(6 years ago) |
Expired
|
| US6194445 | Use of pramipexole in the treatment of restless legs syndrome |
Jan, 2018
(6 years ago) |
Expired
|
FDA has granted several exclusivities to Mirapex. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Mirapex, 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.
Exclusivity Information
Mirapex holds 1 exclusivities. All of its exclusivities have expired in 2014. Details of Mirapex's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-104) | May 13, 2014 |
US patents provide insights into the exclusivity only within the United States, but Mirapex 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's family patents as well as insights into ongoing legal events on those patents.
Mirapex's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Mirapex's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 16, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Mirapex Generic API suppliers:
Pramipexole Dihydrochloride is the generic name for the brand Mirapex. 24 different companies have already filed for the generic of Mirapex, 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's generic
How can I launch a generic of Mirapex before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Mirapex's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Mirapex'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 -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.125 mg, 0.5 mg, 1 mg and 1.5 mg | 24 Jun, 2005 | 1 | 19 Feb, 2008 | 25 Mar, 2011 | Eligible |
| 0.25 mg | 27 May, 2005 | 1 | 19 Feb, 2008 | 25 Mar, 2011 | Eligible |
| 0.75 mg | 31 Jul, 2008 | 1 | 09 Apr, 2010 | 08 Oct, 2010 | Extinguished Eligible |
Alternative Brands for Mirapex
Mirapex which is used for treating moderate to severe primary Restless Legs Syndrome (RLS)., has several other brand drugs 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 | |
|---|---|---|
| Boehringer Ingelheim |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Pramipexole Dihydrochloride, Mirapex's active ingredient. Check the complete list of approved generic manufacturers for Mirapex
About Mirapex
Mirapex is a drug owned by Boehringer Ingelheim. It is used for treating moderate to severe primary Restless Legs Syndrome (RLS). Mirapex uses Pramipexole Dihydrochloride as an active ingredient. Mirapex was launched by Boehringer Ingelheim in 1997.
Approval Date:
Mirapex was approved by FDA for market use on 01 July, 1997.
Active Ingredient:
Mirapex uses Pramipexole Dihydrochloride as the active ingredient. Check out other Drugs and Companies using Pramipexole Dihydrochloride ingredient
Treatment:
Mirapex is used for treating moderate to severe primary Restless Legs Syndrome (RLS).
Dosage:
Mirapex is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |