Olinvyk is a drug owned by Trevena Inc. It is protected by 5 US drug patents filed from 2021 to 2024 out of which none have expired yet. Olinvyk's patents have been open to challenges since 30 October, 2024. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 23, 2032. Details of Olinvyk'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. | |||
| US8835488 | Opioid receptor ligands and methods of using and making same |
Mar, 2032
(6 years from now) | Active |
| US9309234 | Opioid receptor ligands and methods of using and making same |
Mar, 2032
(6 years from now) | Active |
| US11931350 | Opioid receptor ligands and methods of using and making same |
Mar, 2032
(6 years from now) | Active |
| US11077098 | Opioid receptor ligands and methods of using and making same |
Mar, 2032
(6 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9642842 | Opioid receptor ligands and methods of using and making same |
Mar, 2032
(6 years 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 Olinvyk's patents.
Latest Legal Activities on Olinvyk's Patents
Given below is the list of recent legal activities going on the following patents of Olinvyk.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Email Notification Critical | 19 Mar, 2024 | US11931350 |
| Recordation of Patent eGrant | 19 Mar, 2024 | US11931350 |
| Mail Patent eGrant Notification | 19 Mar, 2024 | US11931350 |
| Recordation of Patent Grant Mailed Critical | 19 Mar, 2024 | US11931350 |
| Patent eGrant Notification | 19 Mar, 2024 | US11931350 |
| Patent Issue Date Used in PTA Calculation Critical | 19 Mar, 2024 | US11931350 |
| Email Notification Critical | 29 Feb, 2024 | US11931350 |
| Issue Notification Mailed Critical | 28 Feb, 2024 | US11931350 |
| Email Notification Critical | 06 Feb, 2024 | US11931350 |
| Filing Receipt - Corrected | 06 Feb, 2024 | US11931350 |
FDA has granted several exclusivities to Olinvyk. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Olinvyk, 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 Olinvyk.
Exclusivity Information
Olinvyk holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Olinvyk's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 30, 2025 |
Several oppositions have been filed on Olinvyk's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Olinvyk's generic, the next section provides detailed information on ongoing and past EP oppositions related to Olinvyk patents.
Olinvyk's Oppositions Filed in EPO
Olinvyk has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Feb 28, 2018, by Generics (Uk) Ltd. This opposition was filed on patent number EP12760456A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP12760456A | Feb, 2018 | Generics (UK) Ltd | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but Olinvyk 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 Olinvyk's family patents as well as insights into ongoing legal events on those patents.
Olinvyk's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Olinvyk's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 23, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Olinvyk Generics:
There are no approved generic versions for Olinvyk as of now.
About Olinvyk
Olinvyk is a drug owned by Trevena Inc. It is used for managing acute pain through intravenous injection. Olinvyk uses Oliceridine as an active ingredient. Olinvyk was launched by Trevena in 2020.
Approval Date:
Olinvyk was approved by FDA for market use on 30 October, 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 Olinvyk is 30 October, 2020, its NCE-1 date is estimated to be 30 October, 2024.
Active Ingredient:
Olinvyk uses Oliceridine as the active ingredient. Check out other Drugs and Companies using Oliceridine ingredient
Treatment:
Olinvyk is used for managing acute pain through intravenous injection.
Dosage:
Olinvyk is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1MG/ML (1MG/ML) | SOLUTION | Discontinued | INTRAVENOUS |
| 2MG/2ML (1MG/ML) | SOLUTION | Discontinued | INTRAVENOUS |
| 30MG/30ML (1MG/ML) | SOLUTION | Discontinued | INTRAVENOUS |