Osmolex Er Patent Expiration

Osmolex Er is a drug owned by Supernus Pharmaceuticals Inc. It is protected by 20 US drug patents filed from 2018 to 2024. Out of these, 19 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 15, 2038. Details of Osmolex 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).
US10500170 Composition and method for treating neurological disease
Feb, 2038

(13 years from now)

Active
US10500171 Composition and method for treating neurological disease
Feb, 2038

(13 years from now)

Active
US10512617 Composition and method for treating neurological disease
Feb, 2038

(13 years from now)

Active
US10500172 Composition and method for treating neurological disease
Feb, 2038

(13 years from now)

Active
US10213394 Composition and method for treating neurological disease
Feb, 2038

(13 years from now)

Active
US10213393 Composition and method for treating neurological disease
Feb, 2038

(13 years from now)

Active
US11890261 Composition and method for treating neurological disease
Feb, 2038

(13 years from now)

Active
US8252331 Osmotic device containing amantadine and an osmotic salt
Mar, 2030

(5 years from now)

Active
US8389578 Composition and method for treating neurological disease
Jan, 2028

(3 years from now)

Active
US8574626 Osmotic device containing amantadine and an osmotic salt
Nov, 2025

(1 year, 12 days from now)

Active
US8895614 Composition and method for treating neurological disease
Nov, 2025

(1 year, 7 days from now)

Active
US9072697 Composition and method for treating neurological disease
Nov, 2025

(1 year, 7 days from now)

Active
US8895617 Composition and method for treating neurological disease
Nov, 2025

(1 year, 7 days from now)

Active
US8796337 Composition and method for treating neurological disease
Nov, 2025

(1 year, 7 days from now)

Active
US8895616 Composition and method for treating neurological disease
Nov, 2025

(1 year, 7 days from now)

Active
US8895615 Composition and method for treating neurological disease
Nov, 2025

(1 year, 7 days from now)

Active
US8895618 Composition and method for treating neurological disease
Nov, 2025

(1 year, 7 days from now)

Active
US8987333 Composition and method for treating neurological disease
Nov, 2025

(1 year, 7 days from now)

Active
US8889740 Composition and method for treating neurological disease
Nov, 2025

(1 year, 7 days from now)

Active
USRE39069 Multi-layered osmotic device
May, 2018

(6 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 Osmolex Er's patents.

Given below is the list of recent legal activities going on the following patents of Osmolex Er.

Activity Date Patent Number
Patent litigations
Maintenance Fee Reminder Mailed 15 Apr, 2024 US8252331
Mail Patent eGrant Notification 06 Feb, 2024 US11890261
Recordation of Patent Grant Mailed 06 Feb, 2024 US11890261
Patent Issue Date Used in PTA Calculation 06 Feb, 2024 US11890261
Recordation of Patent eGrant 06 Feb, 2024 US11890261
Email Notification 06 Feb, 2024 US11890261
Patent eGrant Notification 06 Feb, 2024 US11890261
Email Notification 18 Jan, 2024 US11890261
Issue Notification Mailed 17 Jan, 2024 US11890261
Application Is Considered Ready for Issue 27 Dec, 2023 US11890261

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

Osmolex Er's Family Patents

Osmolex Er has patent protection in a total of 10 countries. It has a significant patent presence in the US with 75.5% of its patents being US patents. 3 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Osmolex Er.

Family Patents

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Generic Launch

Generic Release Date:

Osmolex Er's generic launch date based on the expiry of its last outstanding patent is estimated to be Feb 15, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Osmolex Er Generic API suppliers:

Amantadine Hydrochloride is the generic name for the brand Osmolex Er. 30 different companies have already filed for the generic of Osmolex Er, with Strides Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Osmolex Er's generic

Alternative Brands for Osmolex Er

Osmolex Er which is used for treating Parkinson's disease and drug-induced extrapyramidal reactions in adult patients., has several other brand drugs in the same treatment category and using the same active ingredient (Amantadine 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
Bausch
Tasmar Used for managing symptoms of Parkinson's disease.
Boehringer Ingelheim
Mirapex Er Used for managing symptoms of Parkinson's disease.
Glaxosmithkline Llc
Requip Xl used for treating Parkinson's syndrome.
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 Used for managing symptoms of Parkinson's disease.
Stalevo 75 Used for managing symptoms of Parkinson's Disease.
Stalevo 100 Used for managing symptoms of Parkinson's disease.
Stalevo 125 used for managing symptoms of Parkinson's Disease.
Stalevo 150 Used for managing symptoms of Parkinson's disease.
Stalevo 200 Used for managing the symptoms of Parkinson's disease.
Teva
Azilect Used for managing the symptoms of Parkinson's disease.

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. Amantadine Hydrochloride. Given below is the list of those drugs and companies owning them.

Drug Owner Drug Name
Supernus Pharms
Gocovri


Apart from brand drugs containing the same ingredient, some generics have also been filed for Amantadine Hydrochloride, Osmolex Er's active ingredient. Check the complete list of approved generic manufacturers for Osmolex Er





About Osmolex Er

Osmolex Er is a drug owned by Supernus Pharmaceuticals Inc. It is used for treating Parkinson's disease and drug-induced extrapyramidal reactions in adult patients. Osmolex Er uses Amantadine Hydrochloride as an active ingredient. Osmolex Er was launched by Supernus Pharms in 2018.

Approval Date:

Osmolex Er was approved by FDA for market use on 16 February, 2018.

Active Ingredient:

Osmolex Er uses Amantadine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Amantadine Hydrochloride ingredient

Treatment:

Osmolex Er is used for treating Parkinson's disease and drug-induced extrapyramidal reactions in adult patients.

Dosage:

Osmolex Er is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 161MG BASE TABLET, EXTENDED RELEASE Discontinued ORAL
EQ 129MG BASE TABLET, EXTENDED RELEASE Discontinued ORAL
EQ 193MG BASE TABLET, EXTENDED RELEASE Discontinued ORAL
EQ 258MG BASE TABLET, EXTENDED RELEASE Discontinued ORAL