Ohtuvayre is a drug owned by Verona Pharma Inc. It is protected by 5 US drug patents filed from 2024 to 2025 out of which none have expired yet. Ohtuvayre's patents will be open to challenges from 26 June, 2028. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 25, 2044. Details of Ohtuvayre'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. | |||
| US9062047 | Crystalline form of pyrimido[6,1-A] isoquinolin-4-one compound |
Aug, 2031
(5 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). | |||
| US12251384 | Particulate composition |
Jun, 2044
(18 years from now) | Active |
| US12409180 | Formulation Production Process |
Feb, 2043
(16 years from now) | Active |
| US9956171 | Liquid inhalation formulation comprising RPL554 |
Sep, 2035
(9 years from now) | Active |
| US10945950 | Liquid inhalation formulation comprising RPL554 |
Sep, 2035
(9 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 Ohtuvayre's patents.
Latest Legal Activities on Ohtuvayre's Patents
Given below is the list of recent legal activities going on the following patents of Ohtuvayre.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Recordation of Patent eGrant | 09 Sep, 2025 | US12409180 |
| Patent eGrant Notification | 09 Sep, 2025 | US12409180 |
| Mail Patent eGrant Notification | 09 Sep, 2025 | US12409180 |
| Patent Issue Date Used in PTA Calculation | 09 Sep, 2025 | US12409180 |
| Email Notification | 09 Sep, 2025 | US12409180 |
| Email Notification | 28 Aug, 2025 | US12409180 |
| Issue Notification Mailed | 27 Aug, 2025 | US12409180 |
| Information Disclosure Statement (IDS) Filed | 26 Aug, 2025 | US9062047 |
| transaction for FDA Determination of Regulatory Review Period | 26 Aug, 2025 | US10945950 |
| transaction for FDA Determination of Regulatory Review Period | 26 Aug, 2025 | US9062047 |
FDA has granted several exclusivities to Ohtuvayre. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Ohtuvayre, 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
Ohtuvayre.
Exclusivity Information
Ohtuvayre holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Ohtuvayre's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jun 26, 2029 |
US patents provide insights into the exclusivity only within the United States, but
Ohtuvayre 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 Ohtuvayre's family patents as well as insights into
ongoing legal events
on those patents.
Ohtuvayre's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Ohtuvayre's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 25, 2044 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ohtuvayre Generics:
There are no approved generic versions for Ohtuvayre as of now.
About Ohtuvayre
Ohtuvayre is a drug owned by Verona Pharma Inc. Ohtuvayre uses Ensifentrine as an active ingredient. Ohtuvayre was launched by Verona in 2024.
Approval Date:
Ohtuvayre was approved by FDA for market use on 26 June, 2024.
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 Ohtuvayre is 26 June, 2024, its NCE-1 date is estimated to be 26 June, 2028.
Active Ingredient:
Ohtuvayre uses Ensifentrine as the active ingredient. Check out other Drugs and Companies using Ensifentrine ingredient
Dosage:
Ohtuvayre is available in suspension form for inhalation use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 3MG/2.5ML | SUSPENSION | Prescription | INHALATION |