Olinvyk Patent Expiration

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 will be open to challenges from 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.
US11931350 Opioid receptor ligands and methods of using and making same
Mar, 2032

(7 years from now)

Active
US8835488 Opioid receptor ligands and methods of using and making same
Mar, 2032

(7 years from now)

Active
US9309234 Opioid receptor ligands and methods of using and making same
Mar, 2032

(7 years from now)

Active
US11077098 Opioid receptor ligands and methods of using and making same
Mar, 2032

(7 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

(7 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.

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

Activity Date Patent Number
Patent litigations
Email Notification 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 19 Mar, 2024 US11931350
Patent eGrant Notification 19 Mar, 2024 US11931350
Patent Issue Date Used in PTA Calculation 19 Mar, 2024 US11931350
Email Notification 29 Feb, 2024 US11931350
Issue Notification Mailed 28 Feb, 2024 US11931350
Email Notification 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

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

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
Patent litigations
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

Olinvyk has patent protection in a total of 23 countries. It's US patent count contributes only to 21.2% of its total global patent coverage. 2 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 Olinvyk.

Family Patents

Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List


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 Prescription INTRAVENOUS
2MG/2ML (1MG/ML) SOLUTION Prescription INTRAVENOUS
30MG/30ML (1MG/ML) SOLUTION Prescription INTRAVENOUS