Ongentys is a drug owned by Amneal Pharmaceuticals Llc. It is protected by 10 US drug patents filed from 2020 to 2024 out of which none have expired yet. Ongentys's patents have been open to challenges since 24 April, 2024. Based on its patents and exclusivities, its generic launch date is estimated to be May 27, 2035. Details of Ongentys's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US9630955 | Chemical compound useful as intermediate for preparing a catechol-O-methyltransferase inhibitor |
Dec, 2032
(7 years from now) | Active |
| US8168793 | Nitrocatechol derivatives as COMT inhibitors |
Apr, 2029
(3 years from now) | Active |
| US8907099 | Nitrocatechol derivatives as COMT inhibitors |
May, 2027
(1 year, 9 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10357468 | Medicaments for slowing Parkinson's disease |
May, 2035
(9 years from now) | Active |
| US12129247 | Administration regime for nitrocatechols |
Jan, 2032
(6 years from now) | Active |
| US10583130 | Pharmaceutical formulations compromising nitrocatechol derivatives and methods of making thereof |
Mar, 2030
(4 years from now) | Active |
| US10071085 | Pharmaceutical formulations comprising nitrocatechol derivatives and methods of making thereof |
Mar, 2030
(4 years from now) | Active |
| US8524746 | Dosage regimen for COMT inhibitors |
Jul, 2029
(3 years from now) | Active |
| US9745290 | Dosage regimen for COMT inhibitors |
Oct, 2027
(2 years from now) | Active |
| US9550759 | Nitrocatechol derivatives as COMT inhibitors |
Jul, 2026
(1 year, 9 days from now) | Active |
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 Ongentys's patents.
Latest Legal Activities on Ongentys's Patents
Given below is the list of recent legal activities going on the following patents of Ongentys.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 17 Jul, 2024 | US9550759 |
| transaction for FDA Determination of Regulatory Review Period | 29 Feb, 2024 | US10071085 |
| transaction for FDA Determination of Regulatory Review Period | 29 Feb, 2024 | US9630955 |
| transaction for FDA Determination of Regulatory Review Period | 29 Feb, 2024 | US9550759 |
| transaction for FDA Determination of Regulatory Review Period | 29 Feb, 2024 | US8168793 |
| transaction for FDA Determination of Regulatory Review Period | 28 Feb, 2024 | US8524746 |
| transaction for FDA Determination of Regulatory Review Period | 23 Feb, 2024 | US8168793 |
| transaction for FDA Determination of Regulatory Review Period | 23 Feb, 2024 | US9550759 |
| transaction for FDA Determination of Regulatory Review Period | 23 Feb, 2024 | US10071085 |
| transaction for FDA Determination of Regulatory Review Period | 23 Feb, 2024 | US8524746 |
FDA has granted several exclusivities to Ongentys. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Ongentys, 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 Ongentys.
Exclusivity Information
Ongentys holds 1 exclusivities. All of its exclusivities have expired in 2025. Details of Ongentys's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Apr 24, 2025 |
US patents provide insights into the exclusivity only within the United States, but Ongentys 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 Ongentys's family patents as well as insights into ongoing legal events on those patents.
Ongentys's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Ongentys's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 27, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ongentys Generics:
There are no approved generic versions for Ongentys as of now.
About Ongentys
Ongentys is a drug owned by Amneal Pharmaceuticals Llc. It is used for treating Parkinson's disease by providing adjunctive therapy to patients experiencing off episodes in combination with levodopa/carbidopa. Ongentys uses Opicapone as an active ingredient. Ongentys was launched by Amneal in 2020.
Approval Date:
Ongentys was approved by FDA for market use on 24 April, 2020.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Ongentys is 24 April, 2020, its NCE-1 date is estimated to be 24 April, 2024.
Active Ingredient:
Ongentys uses Opicapone as the active ingredient. Check out other Drugs and Companies using Opicapone ingredient
Treatment:
Ongentys is used for treating Parkinson's disease by providing adjunctive therapy to patients experiencing off episodes in combination with levodopa/carbidopa.
Dosage:
Ongentys is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 50MG | CAPSULE | Prescription | ORAL |
| 25MG | CAPSULE | Prescription | ORAL |