Stalevo 125 is a drug owned by Orion Pharma. It is protected by 3 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 Jun 29, 2020. Details of Stalevo 125'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). | |||
| US6500867 | Pharmaceutical composition comprising entacapone, levodopa, and carbidopa |
Jun, 2020
(4 years ago) |
Expired
|
| US6797732 | Pharmaceutical composition comprising entracapone, levodopa, and carbidopa |
Jun, 2020
(4 years ago) |
Expired
|
| US5446194 | Pharmacologically active catechol derivatives |
Oct, 2013
(11 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 Stalevo 125's patents.
Latest Legal Activities on Stalevo 125's Patents
Given below is the list of recent legal activities going on the following patents of Stalevo 125.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Recordation of Patent Grant Mailed Critical | 28 Sep, 2004 | US6797732 |
| Patent Issue Date Used in PTA Calculation Critical | 28 Sep, 2004 | US6797732 |
| Issue Notification Mailed Critical | 09 Sep, 2004 | US6797732 |
| Receipt into Pubs | 03 Sep, 2004 | US6797732 |
| Application Is Considered Ready for Issue Critical | 01 Sep, 2004 | US6797732 |
| Dispatch to FDC | 01 Sep, 2004 | US6797732 |
| Issue Fee Payment Received Critical | 18 Aug, 2004 | US6797732 |
| Issue Fee Payment Verified Critical | 18 Aug, 2004 | US6797732 |
| Receipt into Pubs | 17 Aug, 2004 | US6797732 |
| Receipt into Pubs | 07 Jun, 2004 | US6797732 |
US patents provide insights into the exclusivity only within the United States, but Stalevo 125 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 Stalevo 125's family patents as well as insights into ongoing legal events on those patents.
Stalevo 125's Family Patents
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Generic Launch
Generic Release Date:
Stalevo 125's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 29, 2020 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Stalevo 125 Generic API suppliers:
Carbidopa; Entacapone; Levodopa is the generic name for the brand Stalevo 125. 4 different companies have already filed for the generic of Stalevo 125, with Norvium Bioscience having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Stalevo 125's generic
How can I launch a generic of Stalevo 125 before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Stalevo 125's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Stalevo 125'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 Stalevo 125 -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 12.5 mg, 50 mg and 200 mg | 05 Aug, 2008 | 1 | 20 Nov, 2012 | 29 Jun, 2020 | Extinguished Deferred |
| 18.75 mg/75 mg/ 200 mg and 31.25 mg/125 mg/ 200 mg | 19 May, 2009 | 1 | 20 Nov, 2012 | 29 Jun, 2020 | Deferred |
| 25/100/200 mg and 37.5/150/200 mg | 29 Jun, 2007 | 1 | 10 May, 2012 | 29 Jun, 2020 | Extinguished |
| 50 mg/200 mg/ 200 mg | 28 Aug, 2008 | 1 | Deferred |
Alternative Brands for Stalevo 125
Stalevo 125 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 (Carbidopa; Entacapone; Levodopa). 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 |
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| Boehringer Ingelheim |
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| Impax |
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| Orion Pharma |
| |||||||||||||
| Supernus Pharms |
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| Teva |
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Apart from brand drugs containing the same ingredient, some generics have also been filed for Carbidopa; Entacapone; Levodopa, Stalevo 125's active ingredient. Check the complete list of approved generic manufacturers for Stalevo 125
About Stalevo 125
Stalevo 125 is a drug owned by Orion Pharma. It is used for managing symptoms of Parkinson's Disease. Stalevo 125 uses Carbidopa; Entacapone; Levodopa as an active ingredient. Stalevo 125 was launched by Orion Pharma in 2003.
Approval Date:
Stalevo 125 was approved by FDA for market use on 11 June, 2003.
Active Ingredient:
Stalevo 125 uses Carbidopa; Entacapone; Levodopa as the active ingredient. Check out other Drugs and Companies using Carbidopa; Entacapone; Levodopa ingredient
Treatment:
Stalevo 125 is used for managing symptoms of Parkinson's Disease.
Dosage:
Stalevo 125 is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 31.25MG;200MG;125MG | TABLET | Prescription | ORAL |