Omidria is a drug owned by Rayner Surgical Inc. It is protected by 13 US drug patents filed from 2014 to 2018. Out of these, 5 drug patents are active and 8 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 23, 2034. Details of Omidria'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). | |||
|
US9486406 (Pediatric) | Stable preservative-free mydriatic and anti-inflammatory solutions for injection |
Apr, 2034
(8 years from now) | Active |
|
US9066856 (Pediatric) | Stable preservative-free mydriatic and anti-inflammatory solutions for injection |
Apr, 2034
(8 years from now) | Active |
| US9855246 | Stable preservative-free mydriatic and anti-inflammatory solutions for injection |
Oct, 2033
(7 years from now) | Active |
| US9486406 | Stable preservative-free mydriatic and anti-inflammatory solutions for injection |
Oct, 2033
(7 years from now) | Active |
| US9066856 | Stable preservative-free mydriatic and anti-inflammatory solutions for injection |
Oct, 2033
(7 years from now) | Active |
|
US9278101 (Pediatric) | Ophthalmologic irrigation solutions and method |
Jan, 2024
(1 year, 9 months ago) |
Expired
|
|
US8173707 (Pediatric) | Ophthalmologic irrigation solutions and method |
Jan, 2024
(1 year, 9 months ago) |
Expired
|
|
US8586633 (Pediatric) | Ophthalmologic irrigation solutions and method |
Jan, 2024
(1 year, 9 months ago) |
Expired
|
|
US9399040 (Pediatric) | Ophthalmologic irrigation solutions and method |
Jan, 2024
(1 year, 9 months ago) |
Expired
|
| US9278101 | Ophthalmologic irrigation solutions and method |
Jul, 2023
(2 years ago) |
Expired
|
| US9399040 | Ophthalmologic irrigation solutions and method |
Jul, 2023
(2 years ago) |
Expired
|
| US8586633 | Ophthalmologic irrigation solutions and method |
Jul, 2023
(2 years ago) |
Expired
|
| US8173707 | Ophthalmologic irrigation solutions and method |
Jul, 2023
(2 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 Omidria's patents.
Latest Legal Activities on Omidria's Patents
Given below is the list of recent legal activities going on the following patents of Omidria.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent
Critical | 10 Jun, 2024 | US8173707 (Litigated) |
| Email Notification
Critical | 22 May, 2024 | US9486406 |
| Change in Power of Attorney (May Include Associate POA)
Critical | 22 May, 2024 | US9855246 |
| Email Notification
Critical | 22 May, 2024 | US9855246 |
| Change in Power of Attorney (May Include Associate POA)
Critical | 22 May, 2024 | US9066856 (Litigated) |
| Change in Power of Attorney (May Include Associate POA)
Critical | 22 May, 2024 | US9486406 |
| Email Notification
Critical | 22 May, 2024 | US9066856 (Litigated) |
| Email Notification
Critical | 10 Apr, 2024 | US9486406 |
| Change in Power of Attorney (May Include Associate POA)
Critical | 10 Apr, 2024 | US9486406 |
| Maintenance Fee Reminder Mailed
Critical | 18 Mar, 2024 | US9399040 |
FDA has granted several exclusivities to Omidria. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Omidria, 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
Omidria.
Exclusivity Information
Omidria holds 3 exclusivities. All of its exclusivities have expired in 2021. Details of Omidria's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | May 30, 2017 |
| New Patient Population(NPP) | Dec 08, 2020 |
| Pediatric Exclusivity(PED) | Jun 08, 2021 |
US patents provide insights into the exclusivity only within the United States, but
Omidria 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 Omidria's family patents as well as insights into
ongoing legal events
on those patents.
Omidria's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Omidria's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 23, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Omidria Generic API suppliers:
Ketorolac Tromethamine; Phenylephrine Hydrochloride is the generic name for the brand Omidria. 1 company has already filed for the generic of Omidria. Check out the entire list of companies who have already received approval for Omidria's generic
How can I launch a generic of Omidria before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Omidria's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Omidria's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Omidria -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1%/0.3% | 29 May, 2015 | 1 | 30 Jul, 2023 | Extinguished |
About Omidria
Omidria is a drug owned by Rayner Surgical Inc. It is used for maintaining pupil size during and after eye surgery. Omidria uses Ketorolac Tromethamine; Phenylephrine Hydrochloride as an active ingredient. Omidria was launched by Rayner Surgical in 2014.
Approval Date:
Omidria was approved by FDA for market use on 30 May, 2014.
Active Ingredient:
Omidria uses Ketorolac Tromethamine; Phenylephrine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Ketorolac Tromethamine; Phenylephrine Hydrochloride ingredient
Treatment:
Omidria is used for maintaining pupil size during and after eye surgery.
Dosage:
Omidria is available in solution form for irrigation use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.3% BASE;EQ 1% BASE | SOLUTION | Prescription | IRRIGATION |