Stalevo 75 Patent Expiration

Stalevo 75 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 75'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

(10 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 75's patents.

Given below is the list of recent legal activities going on the following patents of Stalevo 75.

Activity Date Patent Number
Patent litigations
Recordation of Patent Grant Mailed 28 Sep, 2004 US6797732
Patent Issue Date Used in PTA Calculation 28 Sep, 2004 US6797732
Issue Notification Mailed 09 Sep, 2004 US6797732
Receipt into Pubs 03 Sep, 2004 US6797732
Application Is Considered Ready for Issue 01 Sep, 2004 US6797732
Dispatch to FDC 01 Sep, 2004 US6797732
Issue Fee Payment Received 18 Aug, 2004 US6797732
Issue Fee Payment Verified 18 Aug, 2004 US6797732
Receipt into Pubs 17 Aug, 2004 US6797732
Receipt into Pubs 07 Jun, 2004 US6797732

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US patents provide insights into the exclusivity only within the United States, but Stalevo 75 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 75's family patents as well as insights into ongoing legal events on those patents.

Stalevo 75's Family Patents


Family Patents

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Generic Launch

Generic Release Date:

Stalevo 75'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 75 Generics:

Carbidopa; Entacapone; Levodopa is the generic name for the brand Stalevo 75. 4 different companies have already filed for the generic of Stalevo 75, with Norvium Bioscience having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Stalevo 75's generic

How can I launch a generic of Stalevo 75 before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Stalevo 75's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Stalevo 75'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 75 -

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 75

Stalevo 75 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
Tasmar Used for managing symptoms of Parkinson's disease.
Boehringer Ingelheim
Mirapex Er Used for managing symptoms of Parkinson's disease.
Impax
Rytary Used for treating Parkinson's disease and related conditions such as post-encephalitic parkinsonism and parkinsonism from carbon monoxide or manganese intoxication.
Orion Pharma
Comtan Used for treating Parkinson's disease.
Stalevo 50

(uses Carbidopa; Entacapone; Levodopa)

Used for managing symptoms of Parkinson's disease.
Stalevo 100

(uses Carbidopa; Entacapone; Levodopa)

Used for managing symptoms of Parkinson's disease.
Stalevo 125

(uses Carbidopa; Entacapone; Levodopa)

used for managing symptoms of Parkinson's Disease.
Stalevo 150

(uses Carbidopa; Entacapone; Levodopa)

Used for managing symptoms of Parkinson's disease.
Stalevo 200

(uses Carbidopa; Entacapone; Levodopa)

Used for managing the symptoms of Parkinson's disease.
Supernus Pharms
Osmolex Er Used for treating Parkinson's disease and drug-induced extrapyramidal reactions in adult patients.
Teva
Azilect Used for managing the symptoms of Parkinson's disease.

Apart from brand drugs containing the same ingredient, some generics have also been filed for Carbidopa; Entacapone; Levodopa, Stalevo 75's active ingredient. Check the complete list of approved generic manufacturers for Stalevo 75





About Stalevo 75

Stalevo 75 is a drug owned by Orion Pharma. It is used for managing symptoms of Parkinson's Disease. Stalevo 75 uses Carbidopa; Entacapone; Levodopa as an active ingredient. Stalevo 75 was launched by Orion Pharma in 2003.

Approval Date:

Stalevo 75 was approved by FDA for market use on 11 June, 2003.

Active Ingredient:

Stalevo 75 uses Carbidopa; Entacapone; Levodopa as the active ingredient. Check out other Drugs and Companies using Carbidopa; Entacapone; Levodopa ingredient

Treatment:

Stalevo 75 is used for managing symptoms of Parkinson's Disease.

Dosage:

Stalevo 75 is available in tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
18.75MG;200MG;75MG TABLET Prescription ORAL