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). | |||
| US10213393 | Composition and method for treating neurological disease |
Feb, 2038
(12 years from now) | Active |
| US10213394 | Composition and method for treating neurological disease |
Feb, 2038
(12 years from now) | Active |
| US10512617 | Composition and method for treating neurological disease |
Feb, 2038
(12 years from now) | Active |
| US10500170 | Composition and method for treating neurological disease |
Feb, 2038
(12 years from now) | Active |
| US10500171 | Composition and method for treating neurological disease |
Feb, 2038
(12 years from now) | Active |
| US10500172 | Composition and method for treating neurological disease |
Feb, 2038
(12 years from now) | Active |
| US11890261 | Composition and method for treating neurological disease |
Feb, 2038
(12 years from now) | Active |
| US8252331 | Osmotic device containing amantadine and an osmotic salt |
Mar, 2030
(4 years from now) | Active |
| US8389578 | Composition and method for treating neurological disease |
Jan, 2028
(2 years from now) | Active |
| US8574626 | Osmotic device containing amantadine and an osmotic salt |
Nov, 2025
(6 months from now) | Active |
| US8895616 | Composition and method for treating neurological disease |
Nov, 2025
(6 months from now) | Active |
| US8895615 | Composition and method for treating neurological disease |
Nov, 2025
(6 months from now) | Active |
| US8895617 | Composition and method for treating neurological disease |
Nov, 2025
(6 months from now) | Active |
| US8895618 | Composition and method for treating neurological disease |
Nov, 2025
(6 months from now) | Active |
| US8987333 | Composition and method for treating neurological disease |
Nov, 2025
(6 months from now) | Active |
| US8889740 | Composition and method for treating neurological disease |
Nov, 2025
(6 months from now) | Active |
| US8895614 | Composition and method for treating neurological disease |
Nov, 2025
(6 months from now) | Active |
| US8796337 | Composition and method for treating neurological disease |
Nov, 2025
(6 months from now) | Active |
| US9072697 | Composition and method for treating neurological disease |
Nov, 2025
(6 months 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.
Latest 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 |
|---|---|---|
 | ||
| Maintenance Fee Reminder Mailed Critical | 15 Apr, 2024 | US8252331 |
| Mail Patent eGrant Notification | 06 Feb, 2024 | US11890261 |
| Recordation of Patent Grant Mailed Critical | 06 Feb, 2024 | US11890261 |
| Patent Issue Date Used in PTA Calculation Critical | 06 Feb, 2024 | US11890261 |
| Recordation of Patent eGrant | 06 Feb, 2024 | US11890261 |
| Email Notification Critical | 06 Feb, 2024 | US11890261 |
| Patent eGrant Notification | 06 Feb, 2024 | US11890261 |
| Email Notification Critical | 18 Jan, 2024 | US11890261 |
| Issue Notification Mailed Critical | 17 Jan, 2024 | US11890261 |
| Application Is Considered Ready for Issue Critical | 27 Dec, 2023 | US11890261 |
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
Explore Our Curated Drug Screens
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. 31 different companies have already filed for the generic of Osmolex Er, with Invagen Pharms 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 |
| |||||||||||||||
| Boehringer Ingelheim |
| |||||||||||||||
| Glaxosmithkline Llc |
| |||||||||||||||
| Impax |
| |||||||||||||||
| Orion Pharma |
| |||||||||||||||
| 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. Amantadine Hydrochloride. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Supernus Pharms |
|
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 258MG BASE | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| EQ 129MG BASE | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| EQ 193MG BASE | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| EQ 161MG BASE | TABLET, EXTENDED RELEASE | Discontinued | ORAL |