Omidria Patent Expiration

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

(9 years from now)

Active
US9066856

(Pediatric)

Stable preservative-free mydriatic and anti-inflammatory solutions for injection
Apr, 2034

(9 years from now)

Active
US9066856 Stable preservative-free mydriatic and anti-inflammatory solutions for injection
Oct, 2033

(9 years from now)

Active
US9855246 Stable preservative-free mydriatic and anti-inflammatory solutions for injection
Oct, 2033

(9 years from now)

Active
US9486406 Stable preservative-free mydriatic and anti-inflammatory solutions for injection
Oct, 2033

(9 years from now)

Active
US9399040

(Pediatric)

Ophthalmologic irrigation solutions and method
Jan, 2024

(8 months ago)

Expired
US8173707

(Pediatric)

Ophthalmologic irrigation solutions and method
Jan, 2024

(8 months ago)

Expired
US8586633

(Pediatric)

Ophthalmologic irrigation solutions and method
Jan, 2024

(8 months ago)

Expired
US9278101

(Pediatric)

Ophthalmologic irrigation solutions and method
Jan, 2024

(8 months ago)

Expired
US8586633 Ophthalmologic irrigation solutions and method
Jul, 2023

(1 year, 2 months ago)

Expired
US9399040 Ophthalmologic irrigation solutions and method
Jul, 2023

(1 year, 2 months ago)

Expired
US9278101 Ophthalmologic irrigation solutions and method
Jul, 2023

(1 year, 2 months ago)

Expired
US8173707 Ophthalmologic irrigation solutions and method
Jul, 2023

(1 year, 2 months 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.

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

Activity Date Patent Number
Patent litigations
Expire Patent 10 Jun, 2024 US8173707 (Litigated)
Email Notification 22 May, 2024 US9486406
Change in Power of Attorney (May Include Associate POA) 22 May, 2024 US9855246
Email Notification 22 May, 2024 US9855246
Change in Power of Attorney (May Include Associate POA) 22 May, 2024 US9066856 (Litigated)
Change in Power of Attorney (May Include Associate POA) 22 May, 2024 US9486406
Email Notification 22 May, 2024 US9066856 (Litigated)
Email Notification 10 Apr, 2024 US9486406
Change in Power of Attorney (May Include Associate POA) 10 Apr, 2024 US9486406
Maintenance Fee Reminder Mailed 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

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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

Omidria has patent protection in a total of 39 countries. It's US patent count contributes only to 30.7% of its total global patent coverage. 5 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 Omidria.

Family Patents

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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 Generics:

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